Multisite randomized feasibility study of Problem-Solving Training for care partners of adults with traumatic brain injury during inpatient rehabilitation

Abstract

BACKGROUND:

Problem-Solving Training (PST) during inpatient rehabilitation could provide care partners the skills needed to manage their life roles after discharge.

OBJECTIVE:

Determine the feasibility of PST+ Education versus Education for care partners of adults with traumatic brain injury (TBI) during inpatient rehabilitation.

METHODS:

We conducted a multisite randomized feasibility trial across three sites. We present recruitment rates, reasons for refusal to participate, and reasons for non-completion of interventions. We measured client satisfaction, participant engagement, and fidelity for both interventions. We compared change in depressive symptoms and caregiver burden between PST and Education groups.

RESULTS:

Though the interventions were generally feasible, recruitment and retention rates were lower than anticipated largely due to the COVID-19 pandemic. Participants who completed >3 sessions were less likely to be employed full-time and more often spouses and co-residing. Length of inpatient rehabilitation stay was correlated with number of sessions completed. We observed potential benefits of PST over Education, specifically for reducing depression symptoms and caregiver burden.

CONCLUSION:

High satisfaction, engagement, and fidelity, overall recruitment and retention, and positive change in outcomes suggest that PST is generally feasible and beneficial for care partners of persons with TBI. Adaptations, such as developing a 3-session version of PST, could improve feasibility.

Keywords

Caregiver care partner problem-solving training brain injuries behavioral intervention

1 Introduction

Traumatic brain injury (TBI) results in changes in cognitive, physical, emotional, behavioral and social abilities (Reeves & Panguluri, 2011). Long term support for the individual with TBI is typically provided by their care partner (Centers for Disease Control and Prevention, 2015), which most often is an unpaid person such as a spouse, family member or friend who provides assistance with various aspects of their care from activities of daily living (ADL), medical assistance and social/emotional support. Previous work has found that care partners of individuals with TBI report emotional distress – including depression and anxiety - and social difficulties affecting psychological well-being and quality of life (Baker et al., 2016; Carlozzi et al., 2014; Kreutzer et al., 2009; Marsh et al., 2002; Powell, Wise, et al., 2016).

There is a wealth of literature documenting the unmet needs of care partners of individuals with TBI and the negative impact of those unmet needs (Chronister et al., 2016; Davis et al., 2009; Hanks et al., 2007; Kreutzer et al., 2009; Manskow et al., 2015; Rivera et al., 2007; Saban et al., 2016). Relatively less work has examined interventions to benefit the care partners beyond the acute care setting (Backhaus et al., 2010; Damianakis et al., 2016; Kreutzer et al., 2010, 2015). Effective interventions would not only be able to address the current needs of the care partner but also be flexible to adapt as those needs change, for example when the individual with TBI transitions from inpatient care to a home setting (Holland & Shigaki, 1998). An important focus, then, would be to both provide information on living long-term with TBI (McPherson et al., 2000; Murphy & Carmine, 2012) and assist care partners in developing effective coping skills, such as problem-solving skills (Grant et al., 2002; Rivera et al., 2007, 2008).

Care partners not only have to acclimate to the changes in their loved one with TBI but also in the changes in their own lives that have occurred as well. Individuals with TBI have chronic conditions that care partners assist in managing throughout their lives (Corrigan & Hammond, 2013; Langlois et al., 2006). Managing these chronic conditions places a substantial burden on care partners (Arnould et al., 2015; Kolakowsky-Hayner et al., 2001; Kreutzer et al., 1994, 2009; Manskow et al., 2015; Nonterah et al., 2013; Tam et al., 2015) and contributes to emotional distress, ill health and reduced quality of life in care partners (Bayen et al., 2016; Corrigan et al., 2004, 2014; Kolakowsky-Hayner et al., 2001; Kreutzer et al., 1994; Manskow et al., 2015). Therefore, identifying mechanisms to support and reduce care partner burden is crucial.

While brain injury education is often a component of inpatient rehabilitation programs, very few skills, if any, are provided for the care partner to utilize as they transition from the hospital to the home environment. Most inventions to date have occurred once the individual with TBI had been discharged (Baker et al., 2016; Niemeier et al., 2018), but this neglects the critical time of transitioning from the hospital to the home environment where care partners may find themselves without the skills, training or resources needed. Care partners may find themselves unprepared and unable to navigate the new challenges faced when the individual with TBI is now discharged home. Research has shown that the ability to problem-solve has been associated with well-being and those with problem-solving difficulties are more likely to experience emotional distress and greater illnesses (Elliott et al., 2001; Elliott & Shewchuk, 2003). Therefore, a critical need would be to provide evidence-based problem-solving skill training to care partners so they have the skills needed to manage issues that arise over the course of caring for their loved one with TBI.

Interventions that teach proactive problem-solving and goal attainment skills can help care partners better balance the multitude of life roles and challenges they face, which could improve or even prevent the adverse psychosocial outcomes care partners experience. This includes growing evidence for Problem Solving Training (PST), a metacognitive strategy training intervention based in Problem-Solving Therapy concepts (D’Zurilla et al., 2004) and Self-Regulation Theory (McPherson et al., 2009). PST has demonstrated efficacy for improving caregiver burden, mental health, and self-efficacy among care partners, including care partners of those with traumatic injuries (Baker et al., 2016; Elliott et al., 2009; Elliott & Berry, 2009; Grant et al., 2002; Pfeiffer et al., 2014; Powell, Fraser, et al., 2016; Rivera et al., 2008), by teaching a simple step-by-step strategy for assessing problems, generating and selecting solutions, developing action plans, and evaluating and revising plans, as needed. One study of PST in care partners showed benefit for improving depressive symptoms and proactive problem-solving after only 3 intervention sessions (Elliott & Berry, 2009). Another study found that the amount of total time in PST sessions was not associated with treatment effect sizes (Baker et al., 2016). This suggests that PST is a promising brief intervention that could be delivered to care partners during the relatively short duration of their care recipient’s inpatient rehabilitation stay. However, no studies have examined the feasibility of delivering PST to care partners during inpatient rehabilitation for TBI. One small study examined the feasibility of delivering PST to n = 12 care partners of persons with TBI (n = 3), spinal cord injury (n = 1), burn injury (n = 5), or stroke (n = 5) during inpatient rehabilitation (Juengst, Osborne, et al., 2019). This study found that, despite inpatient rehabilitation being a busy and challenging time, few care partners declined to participate as a result of being overwhelmed or too busy, and those who participated in the PST intervention were engaged during sessions and satisfied overall with their experience. They also indicated feeling very confident using the PST strategy after 2-3 sessions, supporting previous studies indicating that PST can be beneficial after a very short time (Juengst, Osborne, et al., 2019).

We propose that PST for care partners during inpatient rehabilitation of individuals with TBI will provide care partners with the skills to manage their caregiving roles across the transition from hospital to home, resulting in less severe depressive symptoms and less caregiver strain. We followed the Obesity-Related Behavioral Intervention Trials (ORBIT) model of behavioral treatment development to develop objectives consistent with the state of the science and to guide our study design. Based on the state of the evidence, we conducted a Phase IIb (Pilot testing) feasibility pilot study to determine the feasibility of a protocol for a future randomized clinical trial by providing information on screening to enrollment ratios, dropout, acceptability of the intervention to the target population, and estimates of the clinical outcomes (e.g., change in depressive symptoms, caregiver burden) that we expect to improve (Czajkowski et al., 2015). Our primary aim was to determine the feasibility of delivering PST+ Education versus Education (control) to care partners of adults with TBI during inpatient rehabilitation. Our secondary aim was to evaluate the effects of PST + Education compared to Education on caregiver burden and depressive symptoms at 1-month after the care recipient’s inpatient rehabilitation discharge. We explored effects at 6-months post-discharge as well. We hypothesized that: (1) Care partners would complete at least three intervention sessions (in person or via telephone) prior to their care recipient’s discharge from inpatient rehabilitation; (2) Care partners would report high engagement and satisfaction in both intervention groups and high confidence in using the PST strategy for those in the PST Intervention; and (3) PST + Education would be associated with more improvement in depressive symptoms and caregiver burden from one-month post-discharge to six-months post-discharge compared to those who received Education only.

2 Methods

2.1 Ethical considerations

All procedures were approved by each site’s Institutional Review Board prior to onset of the study at that site. Participants provided informed consent prior to any study procedures. The study was registered at ClinicalTrials.gov (NCT03739450).

2.2 Participants and recruitment

Participants were care partners of people with TBI undergoing inpatient rehabilitation. Care partners were defined as any individual (spouse, partner, family member, friend, neighbor) contributing to the health and well-being of the person with moderate-to-severe TBI, following diagnostic criteria from the TBI Model Systems (Mellick, 2018). Inclusion criteria were: (1) identified as care partner; (2) ≥1-year relationship; (3) ability to communicate in English; (4) ≥18 years old; and (5) able to self-consent.

Participants were recruited from three TBI Model System Centers between November 2018 and June 2021. Modes of recruitment included flyers distributed by a study team member or through inpatient physician referral, and care partners were approached as close to inpatient rehabilitation admission as feasible.

2.3 Procedures

Participants were randomized and allocated to PST + Education or Education only via stratified, blocked randomization, described in detail in the published protocol paper (S. B. Juengst, Silva, et al., 2019). Allocation assignments for each center were known by each site’s principal investigator and interventionists. A trained research staff, blinded to intervention allocation, then collected baseline data in person, via telephone, or electronically via REDCaptrademark. Participants then completed the PST + Education or Education intervention with the interventionist and follow-up assessments were completed at 1-month and 6-months post-discharge via telephone or REDCaptrademark.

2.4 Measures

Descriptive data collected at baseline included age, education, race, ethnicity, living status, duration of relationship, and quality of relationship. Feasibility (as defined by the ORBIT model) was measured through screening to enrollment ratios, retention dropout rates (number of sessions completed during the inpatient rehabilitation stay, percent followed at 1-month), acceptability of the intervention to the target population (care partner satisfaction, Client Satisfaction Questionnaire 8), and estimates of the clinical outcomes [depressive symptoms using the Patient Health Questionnaire (PHQ9; (Kroenke et al., 2001)) and caregiver burden with the Zarit Burden Interview (ZBI; (Hébert et al., 2000))]. We assessed our ability to deliver PST with high fidelity to the intervention protocol (fidelity protocol, described below, and the Working Alliance Inventory). The effects of the intervention on the secondary outcome of positive aspects of caregiving using the Positive Aspects of Caregiving (PAC; (Tarlow et al., 2004) was also examined. See protocol paper (Juengst, Silva, et al., 2019) for a detailed description of measures.

2.5 Fidelity assessment

We established a fidelity protocol and checklists, described in detail in the previously published protocol paper for this trial (Juengst, Silva, et al., 2019). Briefly, we listened to audio recordings and completed fidelity assessments for 20% of sessions. We measured adherence to the intervention protocol using fidelity checklists and calculated fidelity scores (0-1, with 1 being perfect fidelity for PST sessions) to the PST protocol. Treatment differentiation refers to the degree to which the control/comparison intervention did not include components that it should not include (Perepletchikova & Kazdin, 2005). Therefore, for Education only sessions, a score of 1 was equal to perfect fidelity to the Education protocol, scores <1 indicated missing components in the Education only protocol, and scores >1 indicated “contamination” or inclusion of active components of the PST protocol.

2.6 Interventions

PST follows an established protocol that still offers flexibility to individualize sessions to each participant’s unique needs and goals (Bell et al., 2014; Juengst, Silva, et al., 2019). Participants learn a global problem-solving strategy that can be applied to any problem that they choose to work on during sessions or in the future. For our active control condition, matched to our PST intervention with regard to frequency of contact and perceived benefit to participants, we developed a brief Education-only intervention structured around our TBI Care Partner Workbook. Participants in both intervention groups received this workbook. Multi-professional research staff with master’s level education or equivalent experience provided both interventions using a manualized curriculum described in detail in our published study protocol (S. B. Juengst, Silva, et al., 2019). All intervention sessions occurred in-person or over the telephone. We delivered up to six sessions (∼2-3 per week) up until inpatient discharge. After discharge, a final session was conducted via telephone within 1 week (unless all 6 sessions were completed before discharge).

2.6.1 Problem-solving training + education (active intervention)

The PST intervention consisted of six sessions, lasting 30– 75 minutes, following a structured format. In Session 1, interventionists introduce the participant to the PST steps and structured PST Worksheets and provide participants with the Care Partner Workbook. Through Sessions 2– 5, the interventionist iteratively facilitated the participant’s use of the ABCDEF steps of PST (Assess the problem, Brainstorm solutions, Consider and choose, Develop a plan and do it, Evaluate if the plan worked, Flex the plan or to a new problem), using the PST Worksheets. In the final session (either session 6 or the final post-discharge session), interventionists reviewed progress made and discuss generalization of the PST steps to future problems that may arise.

2.6.2 Education intervention (attention control)

The Education intervention consisted of six sessions as well, generally lasting 15– 30 minutes. In Session 1, interventionists provided participants with the Care Partner Workbook, which we developed for a previous care partner study (Rivera et al., 2008), and brief introduction to its contents. The workbook consists of 12 educational modules for self-study, covering common sequelae of TBI, issues often encountered by care partners, work and school concerns for individuals with TBI, and navigating the rehabilitation system and accessing resources. Sessions 2– 5 consisted of check-ins regarding any questions about the workbook content, summary of the content of the next three chapters, and “homework” to read the next three chapters between sessions. In the final session (either session 6 or the final post-discharge session), the interventionists discussed common problems that may arise post-discharge and how participants could use the Care Partner Workbook as a resource.

2.7 Statistical analysis plan

For our first aim, the primary outcome for feasibility was completion of >3 PST or Education sessions. We report the number and percentage of randomized participants who completed <3 sessions or >3 sessions (across both interventions) and descriptively compared those who did and did not complete >3 sessions on demographic and other baseline factors and on group allocation (PST or Education). We present descriptive statistics for recruitment and retention feasibility including consent rates and attrition at 1-month and 6-month follow-up. For our second aim, the outcome was care partner engagement, satisfaction with the intervention and working alliance with the interventionist in both intervention groups. We also measured differences between intervention groups using t-tests or Mann-Whitney U test as appropriate to the data. We calculated measures of central tendency or numbers and percentages for all demographic baseline variables and descriptively compared those allocated to PST vs Education. For our third aim, to assess whether PST + Education was associated with more improvement in depressive symptoms and caregiver burden from one-month to six-months post-discharge compared to those who received Education only, we calculated change scores (such that positive values indicated improvement in the outcome of interest) and conducted Mann-Whitney U tests for group differences. We present appropriate effect sizes for all comparisons to aid in sample size determination for future Phase III clinical trials.

3 Results

3.1 Recruitment feasibility

During the recruitment period, we contacted n = 224 potential care partner participants, either in person or via telephone. Of those screened, 90.2% were eligible. Reasons for ineligibility are presented in Fig. 1. Twelve eligible participants were unable to participate due to their care recipient’s discharge being too soon. Of those eligible, n = 94 (49.5%) consented to participate and were randomized. Reasons for refusal are presented in Fig. 1.

Fig. 1

Recruitment, consent, and retention flowchart.

Recruitment over time is presented in Fig. 2, both by month and cumulatively. As shown, we fell short of our targeted recruitment goals seemingly as a direct result of restrictions occurring from the COVID-19 pandemic.

Fig. 2

Cumulative and monthly recruitment.

3.2 Participant characteristics

Participant characteristics are presented in Table 1, for all participants and by intervention allocation. The Education group had a larger percentage of White participants than the PST group (83.7% vs 54.1%), with the PST group having a larger percentage of Black/African American participants (21.6% vs 9.3%). The PST group had a higher percentage of divorced participants (24.3% vs 4.7%) and fewer participants co-residing with their care recipient (70.3% vs 83.7%). This group also had a higher proportion of participants who were employed full-time (75.7% vs 53.5%).

Table 1
Participant characteristics

Baseline characteristics All participants PST Education

n = 80^* n = 37 n = 43

n (%) n (%) n (%)

Age, mean (SD) 49.5 (14.0) 49.5 (12.0) 49.5 (15.7)

Gender/sex, n (%)

Men/male 15 (18.8) 8 (21.6) 7 (16.3)

Women/female 65 (81.3) 29 (78.4) 36 (83.7)

Race, n (%)

White 56 (70.0) 20 (54.1) 36 (83.7)

Black/African American 12 (15.0) 8 (21.6) 4 (9.3)

Asian 4 (5.0) 3 (8.1) 1 (2.3)

Multiple races 3 (3.8) 2 (5.4) 1 (2.3)

Unknown/missing 5 (6.2) 4 (10.8) 1 (2.3)

Education

<High school education 6 (7.5) 2 (5.4) 4 (9.3)

High school education 10 (12.5) 4 (24.3) 6 (14.0)

>High school education 64 (80.0) 31 (70.3) 33 (76.7)

Marital status, n (%)

Single 12 (15.0) 4 (10.8) 8 (18.6)

Married/domestic partner 56 (70.0) 24 (64.9) 32 (74.4)

Divorced/separated 11 (13.8) 9 (24.3) 2 (4.7)

Other 1 (1.3) – 1 (2.3)

Current employment status, n (%)

Full-time 51 (63.7) 28 (75.7) 23 (53.5)

Part-time 8 (10.0) 3 (8.1) 5 (11.6)

Homemaker 2 (2.5) – 2 (4.7)

Unemployed 3 (3.8) – 3 (7.0)

Student 2 (2.5) 1 (2.7) 1 (2.3)

Pension/retired 14 (17.5) 5 (13.5) 9 (20.9)

Role-type of care partner, n (%)

Spouse/partner 36 (45.0) 17 (45.9) 19 (44.2)

Parent 18 (22.5) 10 (27.0) 8 (18.6)

Child 19 (23.8) 10 (27.0) 9 (20.9)

Sibling 2 (2.5) – 2 (4.7)

Other relationship 4 (5.1) – 5 (11.6)

Co-residing with care recipient

Yes 62 (77.5) 26 (70.3) 36 (83.7)

No 18 (22.5) 11 (29.7) 7 (16.3)

Relationship quality (1– 10), mean (SD) 8.7 (1.6) 8.6 (1.7) 8.7 (1.5)

range: 2– 10 range: 2– 10 range: 5– 10

Injury mechanism for TBI survivor, n (%)

Motor vehicle accident 33 (41.5) 18 (38.6) 15 (34.9)

Fall 32 (40.0) 13 (35.1) 19 (44.2)

Pedestrian or bicycle accident 6 (7.5) 3 (8.1) 3 (7.0)

Violence 2 (2.5) – 2 (4.6)

Gunshot wound 2 (2.5) 2 (5.4) –

Other/unknown 5 (6.3) 1 (2.7) 4 (9.2)

Rehabilitation length of stay, mean (SD) 24.9 (16.2) 24.9 (16.5) 24.9 (16.2)

Baseline characteristics	All participants	PST	Education
Age, mean (SD)	49.5 (14.0)	49.5 (12.0)	49.5 (15.7)
Gender/sex, n (%)
Men/male	15 (18.8)	8 (21.6)	7 (16.3)
Women/female	65 (81.3)	29 (78.4)	36 (83.7)
Race, n (%)
White	56 (70.0)	20 (54.1)	36 (83.7)
Black/African American	12 (15.0)	8 (21.6)	4 (9.3)
Asian	4 (5.0)	3 (8.1)	1 (2.3)
Multiple races	3 (3.8)	2 (5.4)	1 (2.3)
Unknown/missing	5 (6.2)	4 (10.8)	1 (2.3)
Education
<High school education	6 (7.5)	2 (5.4)	4 (9.3)
High school education	10 (12.5)	4 (24.3)	6 (14.0)
>High school education	64 (80.0)	31 (70.3)	33 (76.7)
Marital status, n (%)
Single	12 (15.0)	4 (10.8)	8 (18.6)
Married/domestic partner	56 (70.0)	24 (64.9)	32 (74.4)
Divorced/separated	11 (13.8)	9 (24.3)	2 (4.7)
Other	1 (1.3)	–	1 (2.3)
Current employment status, n (%)
Full-time	51 (63.7)	28 (75.7)	23 (53.5)
Part-time	8 (10.0)	3 (8.1)	5 (11.6)
Homemaker	2 (2.5)	–	2 (4.7)
Unemployed	3 (3.8)	–	3 (7.0)
Student	2 (2.5)	1 (2.7)	1 (2.3)
Pension/retired	14 (17.5)	5 (13.5)	9 (20.9)
Role-type of care partner, n (%)
Spouse/partner	36 (45.0)	17 (45.9)	19 (44.2)
Parent	18 (22.5)	10 (27.0)	8 (18.6)
Child	19 (23.8)	10 (27.0)	9 (20.9)
Sibling	2 (2.5)	–	2 (4.7)
Other relationship	4 (5.1)	–	5 (11.6)
Co-residing with care recipient
Yes	62 (77.5)	26 (70.3)	36 (83.7)
No	18 (22.5)	11 (29.7)	7 (16.3)
Relationship quality (1– 10), mean (SD)	8.7 (1.6)	8.6 (1.7)	8.7 (1.5)
	range: 2– 10	range: 2– 10	range: 5– 10
Injury mechanism for TBI survivor, n (%)
Motor vehicle accident	33 (41.5)	18 (38.6)	15 (34.9)
Fall	32 (40.0)	13 (35.1)	19 (44.2)
Pedestrian or bicycle accident	6 (7.5)	3 (8.1)	3 (7.0)
Violence	2 (2.5)	–	2 (4.6)
Gunshot wound	2 (2.5)	2 (5.4)	–
Other/unknown	5 (6.3)	1 (2.7)	4 (9.2)
Rehabilitation length of stay, mean (SD)	24.9 (16.2)	24.9 (16.5)	24.9 (16.2)

^*n = 14 participants (n = 6 allocated to PST; n = 8 allocated to Education) who consented did not complete baseline assessment and no information is available for these participants. Rehabilitation length of stay available for n = 64 participants.

3.3 Intervention delivery

Of the 94 participants randomized, n = 43 participants were allocated to PST + Education and n = 51 participants were allocated to Education only. All participants received the Care Partner Workbook (education), though 14 (32.6%) allocated to PST and 23 (45.1%) allocated to Education never received any sessions with the interventionist. Seventeen (39.5%) allocated to PST met the targeted number of sessions (3+) compared to 22 (43.1%) allocated to Education only. See Table 2 for a complete summary of retention. Characteristics of participants across both intervention groups who received 0 sessions, 1-2 sessions, or 3+ sessions are presented in Table 3. Of note, those who received 3+ sessions were less often employed full-time and were more often spouses/partners rather than children or other relationships to their care recipient. Also, average length of stay was shortest for those who received no sessions and longest for those who received 3+ sessions, with total numbers of sessions and length of rehabilitation stay significantly positively correlated overall (r = 0.313, p = 0.012).

Table 2
Sessions completed and retention by intervention allocation

PST Education

n = 43 n = 51

Completed intervention sessions

0 14 (32.6) 23 (45.1)

1-2 12 (27.9) 6 (11.8)

3+ 17 (39.5) 22 (43.1)

Completed baseline assessment 37 (86%) 42 (82%)

Completed 1-month follow-up assessment 17 (46% ^) 25 (60% ^)

Completed 6-month follow-up assessment 18 (49% ^) 22 (52% ^)

	PST	Education
Completed intervention sessions
0	14 (32.6)	23 (45.1)
1-2	12 (27.9)	6 (11.8)
3+	17 (39.5)	22 (43.1)
Completed baseline assessment	37 (86%)	42 (82%)
Completed 1-month follow-up assessment	17 (46% ^*)	25 (60% ^*)
Completed 6-month follow-up assessment	18 (49% ^*)	22 (52% ^*)

^*Calculated as percentage of those who completed baseline assessment. Difference in number of sessions completed by intervention allocation was not statistically significant: $X_{2}^{2}$ = 4.18, p = 0.124.

Table 3

Participant characteristics by number of intervention sessions received

Baseline characteristics	No intervention sessions	1-2 intervention sessions	3+ intervention sessions
	n = 27	n = 17	n = 36
	n (%)	n (%)	n (%)
Age, mean (SD)	49.1 (13.0)	50.8 (13.9)	49.6 (15.1)
Gender (English)/sex, n (%)
Men/male	7 (18.9)	5 (27.8)	7 (17.9)
Women/female	30 (81.1)	13 (72.2)	32 (82.1)
Race, n (%)
White	25 (80.6)	8 (44.4)	29 (80.6)
Black/African American	4 (12.9)	4 (22.2)	5 (13.9)
Asian	1 (3.2)	3 (16.7)	–
Multiple races	1 (3.2)	2 (11.1)	1 (2.8)
Unknown/missing	–	1 (5.6)	1 (2.8)
Education
<High school education	1 (3.7)	–	5 (13.9)
High school education	4 (14.8)	1 (5.9)	5 (13.9)
>High school education	23 (81.5)	16 (94.1)	26 (72.2)
Marital status, n (%)
Single	4 (14.8)	3 (17.6)	5 (13.9)
Married/domestic partner	18 (66.7)	11 (64.7)	27 (75.0)
Divorced/separated	4 (14.8)	3 (17.6)	4 (11.1)
Other	1 (3.7)	–	–
Current employment status, n (%)
Full-time	20 (74.1)	12 (70.6)	19 (52.8)
Part-time	2 (7.4)	1 (5.9)	5 (13.9)
Homemaker	–	–	2 (5.6)
Unemployed	2 (7.4)	–	1 (2.8)
Student	–	–	2 (5.6)
Pension/retired	3 (11.1)	4 (23.5)	7 (19.4)
Role-type of care partner, n (%)
Spouse/partner	9 (33.3)	6 (35.3)	21 (58.3)
Parent	6 (22.2)	4 (23.5)	8 (22.2)
Child	10 (37.0)	6 (35.3)	3 (8.3)
Sibling	1 (3.7)	–	1 (2.8)
Other relationship	1 (3.7)	1 (5.9)	3 (8.4)
Co-residing with care recipient
Yes	16 (59.3)	15 (88.2)	31 (86.1)
No	11 (40.7)	2 (11.8)	5 (13.9)
Relationship quality (1– 10), mean (SD)	8.7 (1.8)	8.5 (1.4)	8.8 (1.5)
Injury mechanism for TBI survivor, n (%)
Motor vehicle accident	12 (44.4)	6 (35.3)	15 (41.1)
Fall	10 (37.0)	6 (35.3)	16 (44.4)
Pedestrian or bicycle accident	2 (7.4)	2 (11.8)	2 (5.6)
Violence	1 (3.7)	–	1 (2.8)
Gunshot wound	1 (3.7)	1 (5.9)	–
Other/unknown	1 (3.7)	2 (11.8)	2 (5.6)
Rehabilitation length of stay, mean (SD)	19.2 (11.3)	25.6 (17.9)	28.6 (17.7)

Rehabilitation length of stay available for n = 21 of 27 who received no sessions, n = 14 of 17 who received 1-2 sessions, and 29 of 36 who received 3+ sessions.

Trained raters evaluated intervention fidelity per our fidelity protocol [described in detail in our protocol paper (Juengst, Silva, et al., 2019)] for 77 PST sessions and 106 Education sessions. Scores range from 0-1, with a score of 1 indicating perfect fidelity. Average fidelity was 0.96 for PST and 0.98 for Education, indicating that both interventions were delivered per protocol.

Participants in both intervention groups were highly satisfied with the intervention and reported a strong working alliance with their interventionist, as demonstrated by CSQ8 and WAI scores presented in Table 4. They were also, on average, highly engaged across sessions, as measured by the PRPS (see Table 4). On the open-ended question at the end of the CSQ8, one participant in the PST group noted that the “training has spilled over to problem and decision process [in] overall life” and that she was “sitting down this morning doing goal-setting” on the day she completed her follow-up assessments. A participant in the Education group stated that “the book was very helpful.” This provides support that the education intervention was an effective attention control condition (Juengst et al., 2020), providing an engaging and satisfying intervention that participants perceived as valuable. Therefore, differences in intervention efficacy between PST and this Education intervention could reasonably be attributable to just the problem-solving strategy training taught in PST and the coaching provided to practice the strategy.

Table 4

Satisfaction, engagement, and clinical effects

Satisfaction and engagement	PST		Education		p value,
	n = 37		n = 43		Cohen’s d
	mean (SD), range		mean (SD), range
Client Satisfaction Questionnaire (8– 32)	16	27.5 (4.2), 19– 32	18	28.3 (5.1), 15– 32	p = 0.615, d = – 0.172
Pittsburgh Rehabilitation Participation Scale (0– 6) *average per person across all intervention sessions received
	27	5.0 (0.75), 3.5– 6.0	29	4.8 (0.71), 3.7– 6.0	p = 0.389, d = 0.232
Working Alliance Inventory (7– 77)	16	66.1 (13.4), 24– 77	18	64.3 (14.6), 22– 78	p = 0.715, d = 0.126
Clinical effects	n	Mean (SD),	n	Mean (SD),	p value,
		range		range	Cohen’s d
Depression (Patient Health Questionnaire)
Baseline	37	8.6 (6.4), 0– 24	42	7.4 (5.3), 0– 20
1-month post-discharge	17	8.1 (6.5), 0– 20	25	5.3 (4.6), 0– 16
6-months post-discharge	18	5.4 (4.5), 0– 12	22	4.4 (4.0), 0– 16
1-to-6 month change (positive = improvement)	11	2.9 (4.8), – 3– 13	17	1.5 (3.2), – 4– 8	p = 0.571, d = 0.355
Caregiver burden (Zarit Burden Interview)
1-month post-discharge	17	26.2 (15.9), 7– 57	25	19.7 (14.6), 0– 54
6-months post-discharge	18	22.6 (15.6), 0– 66	20	15.2 (11.6), 0– 37
1-to-6 month change (positive = improvement)	11	7.7 (10.4), – 8– 21	16	2.6 (10.0), – 25– 17	p = 0.255, d = 0.502
Exploratory effects	n	Mean (SD),	n	Mean (SD),
		range		range
Positive aspects of caregiving
1-month post-discharge	17	35.4 (6.6), 18– 45	24	36.4 (6.3), 20– 45
6-months post-discharge	18	34.5 (5.4), 23– 41	21	36.5 (7.5), 22– 45
1-to-6 month change (positive = improvement)	11	– 0.18 (4.2), – 8– 5	17	– 0.82 (6.7), – 18– 10	p = 0.781, d = 0.109

3.4 Outcomes

Clinical effects for depressive symptoms, caregiver burden, and positive aspects of caregiving are presented in Table 4. Though change scores were not statistically significant (as a feasibility study, we were not powered for efficacy), there was a small to medium effect size for a greater reduction in depressive symptoms from 1-month to 6-months in the PST group compared to the Education group and a medium effect size for a greater reduction in caregiver burden, again favoring the PST group. Very little change was noted in either group for positive aspects of caregiving, suggesting that this may either not be affected by these interventions or that the PAC is not sensitive enough to change in this context.

4 Discussion

We determined the feasibility and acceptability of PST for care partners of adults with TBI, compared to care partner education only, delivered during inpatient rehabilitation and identified factors that may affect recruitment and intervention retention. Participants were satisfied with both the PST and Education interventions, developed a strong working alliance with the interventionist, and had high levels of engagement. Improvement in depressive symptoms and caregiver burden from 1-to-6-months post-discharge favored PST, suggesting that care partners were indeed learning problem-solving skills that helped them in the months post-discharge. However, though the interventions were generally feasible, both recruitment and retention rates were lower than anticipated largely due to unanticipated challenges associated with the COVID-19 pandemic.

Consent rates among those who were eligible in our study fell just below half (47%). Though much lower than one previous study of PST for care partners of adults with stroke (85%; Rivera et al., 2008), it was relatively comparable to a study of PST for care partners of adults with TBI after discharge (51%; Grant et al., 2002) and slightly higher than a study of PST for care partners of adults with traumatic injuries or stroke during inpatient rehabilitation (41%; Juengst, Osborne, et al., 2019). It is encouraging that, until inpatient and research operations dramatically changed in March of 2020, we were on pace to meet our original target recruitment rates. It is likely that some care partners are ready and able to engage in an intervention like this during inpatient rehabilitation, whereas others may better be served at a time post-discharge. Qualitative studies probing preferences about timing of intervention – similar to those that have evaluated care partner needs (Gan et al., 2010; Rotondi et al., 2007) – could help inform personalized intervention approaches. Working with care partners during this phase of a patient’s rehabilitation can be difficult. During the acute phase of rehabilitation, care partners often have the burden of maintaining a household and seeing to obligations the patient may have otherwise managed (e.g., bill paying, parenting, etc.). They may also be the contact person who communicates with the rehabilitation team, liaises with the patient’s workplace, completes lengthy paperwork associated with applying for disability on behalf of the patient, acquires power of attorney, attends family training sessions with therapists for safe discharge to home, and coordinates with staff regarding home medical equipment and delivery. All these activities require time and effort, so care partners may simply be too overwhelmed with the immediate needs of the patient to engage in research. In addition, the anticipated discharge date for patients to return home, or go on to the next phase of the rehabilitation process, is ever-changing depending on the patient’s medical and/or insurance status. Not only does this uncertain timing affect their ability to participate in a clinical trial such as this, but it is also another source of anxiety for care partners.

Retention in our intervention groups, when defining retention as completion of at least 3 sessions for both the PST and Education groups, was comparable to another study on PST for care partners of individuals with dementia and mild cognitive impairment (Garand et al., 2014), but was lower than a study of PST for care partners of individuals with TBI after rehabilitation discharge (Rivera et al., 2008) and a study of PST for care partners of individuals with traumatic injuries or stroke during inpatient rehabilitation (Juengst, Osborne, et al., 2019). Both time and personal factors affected ability to complete intervention sessions; that is, in our study, participants who did not complete the targeted minimum of 3 sessions may have been unable or unwilling to do so for personal reasons or may have just been restricted by the number of days available before their care recipient’s discharge. Not surprisingly given the nature of the study design in which sessions ended after discharge, the care recipient’s length of rehabilitation stay was significantly associated with the total number of sessions the care partner completed. As lengths of stay have become increasingly shorter, care partners are left with fewer opportunities to acquire training and support and less time to adjust to new roles and new realities before having to navigate them on their own. With sufficient infrastructure to continue providing PST sessions via telephone or videoconference beyond the inpatient rehabilitation discharge date, care partners would have the opportunity to complete more sessions, thereby getting more support. In the absence of such infrastructure, we have also adapted our PST protocol such that there is now a 3-session version that incorporates all aspects of the 6-session version in fewer sessions (Juengst et al., 2021), sacrificing number of opportunities for iterative practice with coaching from the interventionist.

Among those who completed the minimum number of sessions, more were not employed full-time, whereas more were employed full-time among those who completed less than three sessions. This is consistent with findings from a prior study indicating that care partners who were employed had greater role overload (i.e., feeling overwhelmed by the responsibilities of caregiving) compared to those who were not employed, even after role overload increased over time for those not employed (Liu et al., 2019). Factors like role overload, time commitment of the interventions, and challenges with scheduling interventions after work, during a lunch break, etc. may limit the number of sessions that are feasible for employed care partners. Participants who completed at least three sessions were also more likely to be spouses versus another type of care partner (e.g., sibling, parent) and were more likely to live with their care recipient. This finding is consistent with a previous study on caregivers of veterans that found that spouses had lower health-related quality of life and that those who lived with their care recipients had higher levels of objective burden (which was predictive of health-related quality of life) compared to other types of care partners or those not co-residing (Hughes et al., 1999). Spousal care partners may be experiencing more distress, leading them to be more motivated to seek help and engage in emotionally-supportive interventions like PST. Similarly, while factors like employment may have posed challenges for care partners in completing the sessions, proximity to the care recipient (i.e., co-residing) may strengthen the desire for the care partner to engage in interventions that could be beneficial to them or their care recipient. Special consideration may need to be given to adapting the intervention to better meet the needs of employed care partners and to better target those specific care partners who need – and are ready to engage in – this type of intervention.

We also observed potential benefits of PST over Education, specifically for reducing depression symptoms and caregiver burden, consistent with evidence for PST efficacy from prior research (Chiu et al., 2015; Garand et al., 2014, 2019; Grant et al., 2002; Rivera et al., 2008). Given the high level of satisfaction and engagement in both interventions, the greater improvement in these symptoms for those who received PST may be attributable to the active components of PST – namely, the problem-solving strategy and facilitative/coaching approach. PST is thought to help people gain greater self-efficacy for solving their problems, feel like they can break problems down in a rational and manageable way, and regulate their negative emotions related to problem-solving (D’Zurilla et al., 2004; Grant et al., 2002; Rivera et al., 2008). PST provides a brief and systematic way of breaking down problems, providing care partners with an adaptive skill not acquired in the Education intervention. Although our findings regarding depression and caregiver burden were not significant, we anticipated that our sample size would not provide sufficient power to detect statistically significant differences (given that this was a feasibility rather than an efficacy trial). However, the effect sizes for the differences between intervention groups in the change in depressive symptoms and caregiver burden provide promising evidence of the potential efficacy of PST in this population and the justification to pursue future studies with care partners of adults with TBI.

If we could identify and then reduce barriers to providing evidence-based interventions to support care partners of adults with TBI early in the rehabilitation process, we could potentially prevent many of the adverse psychological and psychosocial consequences that they experience. The standardized PST intervention we examined herein could be incorporated, with minor modifications, into routine service delivery on the inpatient rehabilitation unit and could be provided by various hospital staff, such as social workers, case managers, or family liaisons. Further, if we could overcome barriers to feasibility and demonstrate efficacy, this PST intervention could be “scaled up” to care partners of patients with other traumatic injuries or acquired conditions (e.g., a larger scale version of the small pilot study already conducted among care partners of patients with TBI, spinal cord injury, burn injury, or stroke; Juengst, Osborne, et al., 2019).

4.1 Limitations

The COVID-19 pandemic presented new, unprecedented challenges. The COVID-19 pandemic began affecting the U.S. just as the study was midway through its 2nd year (March 2020) of recruitment for a study that was anticipated to end in 2022. The pandemic meant that visitation hours were severely reduced or restricted for families and all recruitment efforts were therefore transitioned to phone recruitment. While sites had general success transitioning to remote methods, recruitment efforts were not as fruitful when done solely over the phone as they were in-person, and delays occurred as updates to regular requirements and consent procedures were made. Further, many types of hospital research-based activities were put on a hiatus completely until the pandemic numbers were better controlled. The onset of a global pandemic also meant that care partners had additional stressors due to the overall changes in their lives or were too concerned about the COVID-19 implications for the health of their loved ones to engage in a research study.

Another limitation occurring from the transition to remote procedures was the reliance on technology to complete the baseline and follow-up questionnaires and, in some cases, to receive study worksheets and materials. Some care partners were not used to using computers and email and didn’t have the technology skills to download materials. Though mailing materials and consent forms was an option, the time sensitive nature of enrollment in this study and the slowness of sending materials via mail made this a generally unsuccessful option.

5 Conclusion

Overall, the favorable feedback, high levels of engagement and rapport, high fidelity of intervention delivery, and retention levels for both interventions indicate that this study design was feasible, that both interventions have perceived value and potential benefit for participants, and that PST may be more beneficial than Education alone for improving depressive symptoms and caregiver burden in this population of care partners of individuals with TBI. As with any behavioral intervention, the ability to be adaptable to the individual and their circumstances – such as having options as to number of sessions, timing of sessions, and mode of session delivery – will likely maximize the benefit of PST.

Conflict of interest

None to report.

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	PST	Education
	n = 43	n = 51
Completed intervention sessions
0	14 (32.6)	23 (45.1)
1-2	12 (27.9)	6 (11.8)
3+	17 (39.5)	22 (43.1)
Completed baseline assessment	37 (86%)	42 (82%)
Completed 1-month follow-up assessment	17 (46% ^*)	25 (60% ^*)
Completed 6-month follow-up assessment	18 (49% ^*)	22 (52% ^*)