Abstract
Objective:
Our aim was to investigate the benefit of ongoing family-based treatment (FBT) sessions for adolescent anorexia nervosa if remission criteria were not met at session 20.
Method:
Participants were 69 medically unstable adolescents with Diagnostic and Statistical Manual of Mental Disorders (4th ed; DSM-IV) anorexia nervosa from a randomized controlled trial investigating length of hospital admission prior to outpatient FBT. Participants were divided post hoc into those meeting remission criteria at session 20 (n = 16), those that had not remitted but continued with FBT (n = 39) and those who ceased FBT undertaking alternative treatments (n = 14). Outcome was assessed as remission and hospital readmission days at 12 months after FBT session 20.
Results:
There were no differences between groups at baseline. There was a significant difference in the use of hospital admission days with those in the Alternate Treatment Group who did not continue with FBT using 71.93 days compared to those in Additional FBT Group with only 12.51 days (F(2, 66) = 13.239, p < .01). At 12 months after FBT session 20, the Additional FBT Group had a 28.2% increase in remission rate, significantly higher than those in the Alternate Treatment Group (χ2(2) = 17.68, p < .001).
Discussion:
Continuing FBT after session 20 if remission is not achieved can significantly reduce hospital readmission days and improve remission rates.
Family-based treatment (FBT) (Lock, Le Grange, Agras, & Dare, 2001) is the most widely researched and established treatment for adolescent anorexia nervosa (AN) (Jewell, Blessitt, Stewart, Simic, & Eisler, 2016). Efficacy has been confirmed in multiple randomized control trials (RCTs) in the United Kingdom, United States and Australia (Agras et al., 2014; Eisler, Simic, Russell, & Dare, 2007; Le Grange, Eisler, Dare, & Russell, 1992; Lock et al., 2010; Madden, Miskovic-Wheatley, Wallis, Kohn, Hay, et al., 2015; Robin et al., 1999; Russell, Szmukler, Dare, & Eisler, 1987). Despite this a substantial number of patients are not fully remitted at the end of treatment or 12-month follow-up, with only 30%–50% achieving both a healthy weight (>95% expected body weight (EBW) and reductions in eating disorder psychopathology to within community levels (Le Grange et al., 2016; Lock et al., 2015; Lock et al., 2010; Madden, Miskovic-Wheatley, Wallis, Kohn, Lock, et al., 2015). It remains unclear which components of FBT are essential to achieving remission and whether additional sessions improves outcome in those who are not remitted following the recommended 20 session treatment dose. The exception is early weight gain in the first month of treatment, which predicts remission at end of treatment and 12-month follow-up (Accurso, Ciao, Fitzsimmons-Craft, Lock, & Le Grange, 2014; Doyle, Le Grange, Loeb, Doyle, & Crosby, 2010; Le Grange, Accurso, Lock, Agras, & Bryson, 2014; Madden, Miskovic-Wheatley, Wallis, Kohn, Hay, et al., 2015).
Twenty sessions of FBT over a 12-month period is the recommended dose in the treatment manual (Lock et al., 2001). However, recent RCTs have implemented this variably with treatment doses between 10 and 24 sessions across time spans of 6–12 months (Agras et al., 2014; Le Grange et al., 2016; Lock, Agras, Bryson, & Kraemer, 2005; Lock et al., 2010). While 10 sessions has been shown to produce equivalent results to 20 sessions in less unwell patients, longer treatment was still more beneficial for those with higher levels of psychiatric comorbidity (Lock et al., 2005). In addition, FBT delivered in specialist outpatient clinics report a proportion of patients requiring closer to 30 sessions to achieve treatment goals (Le Grange, Binford, & Loeb, 2005; Lock, Le Grange, Forsberg, & Hewell, 2006). Naturalistic follow-up studies report additional treatment post RCT protocols as common, with approximately 35% of patients having further treatment (Agras et al., 2014; Lock et al., 2010; Madden, Miskovic-Wheatley, Wallis, Kohn, Lock, et al., 2015). While 20 sessions of FBT is the recommended treatment dose, the above suggests this may be inadequate for some patients, especially those with high levels of severity. Currently, no guidelines exist if treatment goals are not met by session 20 of FBT, and it is unclear whether providing additional FBT sessions without augmentation conveys any additional benefit.
The primary aim of this study was to investigate the benefit of additional FBT sessions if remission did not occur by session 20. We hypothesized that patients who were not remitted at session 20 but continued on with FBT sessions would have a better outcome at 12-month follow-up than those who changed treatment modality. Our primary outcomes were rate of remission and hospital readmission days at 12-month follow-up.
Method
Participants
This was a naturalistic post hoc exploratory study of a subset of adolescents from a two-site RCT (n = 82) comparing brief hospitalization for medical stabilization to hospitalization for weight restoration (i.e. until patients reached 90% EBW) followed by a 20-session protocol of FBT (Madden, Miskovic-Wheatley, Wallis, Kohn, Lock, et al., 2015). Four patients withdrew from inpatient treatment and nine patients withdrew from outpatient FBT before protocol completion, leaving 69 participants for this analysis. Participants met Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; American Psychiatric Association, 1994) (American Psychiatric Association, 2000) criteria for AN of less than 3 years duration and were medically unstable (hypothermic (temperature < 35.5°C), brady-cardic (heart rate < 50 beats/min), hypotensive (blood pressure <80 mmHg systolic and < 40 mmHg diastolic), orthostatic instability (pulse increase >20 beats/min, systolic blood pressure decrease >20 mmHg) or QT interval corrected for heart rate >0.45 s). No participants were excluded due to co-morbid psychiatric condition. Patients were refed with a combination of nasogastric feeds and supported meals. No patient had received manualized FBT prior to the study or a hospital admission for an eating disorder at either site. Further details of the refeeding protocol and hospital program have been reported elsewhere (Madden, Miskovic-Wheatley, Wallis, Kohn, Lock, et al., 2015). The subset (n = 69) that completed the FBT protocol (20 FBT sessions, unless treatment goals were met prior) were the focus of this study.
Treatment
FBT fidelity was assessed by reviewing a random sample (5%) of video recorded sessions by an author of the treatment manual (Madden, Miskovic-Wheatley, Wallis, Kohn, Lock, et al., 2015). Treatment phase change occurred when the criteria outlined in the manual were achieved rather than a prescribed number of sessions. If the treatment goals were not met by session 20, further treatment was offered, including additional FBT or an alternative treatment if clinically indicated after consultation with the family. These included individual cognitive behavioral therapy or supportive psychotherapy with social workers, psychologists or a psychiatrist specialized in the treatment of adolescent AN. Final decisions regarding additional treatment were made collaboratively between the treating team, adolescent and their families with the family having the final say in the type of treatment engaged in. It is worth noting that manualized FBT is the main treatment provided by this service. The clinicians involved in the randomized controlled trial provided the alternative treatments for most patients, with all continuing medical care in the service.
Additional FBT sessions continued the treatment goals appropriate to the patient’s clinical presentation, with treatment frequency and changes in treatment phase based on clinical indicators of progress as listed in the treatment manual (Lock et al., 2001). Treatment continued until goals were met or adequate progress was made in consultation with family, medical team and therapist. All families continued with medical and psychiatric reviews as needed.
Measures
The primary outcome measure was remission at 12-month follow-up determined by EBW of 95% or greater, calculated using the Centers for Disease Control and Prevention (CDC) growth charts (Kuczmarski et al., 2000) and Eating Disorder Examination (EDE) global score within 1 SD of community norms (Cooper, Cooper, & Fairburn, 1989; Fairburn & Beglin, 1994). The other primary outcome included number of hospital readmission days after discharge. Post-admission assessments occurred at session 20 and 12-months post session 20.
Statistical analysis
Analysis at baseline, session 20 and 12-month follow-up used independent and paired samples t-tests and one-way analysis of variance (ANOVA) for continuous variables and χ2 tests with Yate’s continuity correction for analysis of categorical data. IBM SPSS Statistics for MAC was used for analysis.
Informed consent
This study was approved by the Human Research Ethics Committee of Sydney Children’s Hospital Network, Westmead Campus (2006/114). Participants gave informed written consent.
Results
Participants were predominantly female (94%) with a mean age of 14.72 years (SD = 1.39). All participants were medically unstable at assessment. Demographic and clinical characteristics of the cohort are reported in Table 1 with notably high levels of comorbidity and eating disorder psychopathology. To investigate the primary aim, the benefit of continuing FBT sessions if remission was not achieved at session 20, participants were divided post hoc into three groups for analysis: those who met remission criteria at session 20 (n = 16; Remitted Gp), those who were not remitted but continued with FBT (n = 39; Continue FBT Gp) and those who were not remitted but ceased FBT in phase 1 because they were not achieving the treatment goals, moving to other treatment (n = 14; Alternate Treatment Gp). There was no significant difference in any characteristic between the three groups at baseline or months to session 20.
Demographic, treatment characteristics and outcomes.
OCD: obsessive compulsive disorder; FBT: family-based treatment; EBW: expected body weight; EDE: Eating Disorder Examination.
A one-way analysis of variance between groups with post hoc-analysis showed that each group in bold italics was significantly different from each other at the p < .05 level.
A one-way analysis of variance between groups with post hoc-analysis showed that the group in bold italics was significantly different from the other two groups at the p < .05 level.
A χ2 test for independence was conducted to compare group differences for categorical variables showed that the group in bold italics was significantly different from the other two groups at the p < .05 level.
A χ2 test for independence was conducted to compare group differences for categorical variables. Each group was significantly different from each other at the p < .05 level.
At session 20, the only difference between unremitted groups was weight, with Continue FBT Gp at a significantly higher weight (94.51% EBW) than Alternate Treatment Gp (89.19% EBW; F(2, 66) = 11.358, p < .001)). Post hoc comparisons using the Tukey’s honestly significant difference (HSD) test indicating significant difference between all three groups. There was no significant difference in EDE global between Continue FBT Gp and Alternate Treatment Gp at session 20. Exploring early weight gain at week 4 of FBT did not identify a difference between the Continue FBT and Alternate Treatment Gp (M = 1.08, SD = 2.09 vs M = 0.53 kg, SD = 2.00), with the only difference between the Remission Gp (M = 2.28, SD = 1.64) and Alternate Gp (F(2, 66) = 12.688, p = .05).
At 12-month follow-up, there was a significant difference in rate of remission between the Continue FBT Gp and the Alternate Treatment group (28.2% in the Continue FBT Gp versus 14.3% in the Alternate Treatment Gp (χ2(2) = 17.68, p < .001).
The total number of admission days from commencement of FBT to 12-month follow-up was highest for the Alternate Treatment Gp (M = 71.93; SD = 68.28) followed by Continue FBT Gp (M = 12.51; SD = 24.67) and the Remitted Gp having the lowest readmission days (M = 10.56; SD = 33.12; F(2, 66) = 13.239, p < .001) with post hoc analysis indicating that the Alternate Treatment Gp readmission days were significantly higher than the other two groups.
Discussion
The aim of this study was to investigate the impact of continuing FBT past the 20 sessions recommended in the treatment manual (Lock & Le Grange, 2013). The remission rate at session 20 was 23%, and by 12-month follow-up the overall remission rate (37.68%) was similar to other studies (Lock et al., 2010) which was promising given all patients were initially medically unstable, and hospitalization is predictor of poor outcome (Le Grange et al., 2012). The majority of participants who did not meet remission criteria at session 20 continued FBT sessions, with 28.2% of these patients reaching remission at 12-month follow-up, significantly more than those who moved to alternative eating disorder treatments at 14.3%.
In addition to differences in remission rates, there was a significant and striking difference between the Continue FBT Gp and the Alternate Treatment Gp in hospital readmission days, with those in the Alternate Treatment Gp needing almost six times more admission days by 12-month follow-up. As hospital admission is generally seen as an indicator of poor outcome (Gowers, Weetman, Shore, Hossain, & Elvins, 2000), this is a critical finding as reducing admissions is likely to decrease the risk of poor long-term outcome (Steinhausen, Grigoroiu-Serbanescu, Boyadjieva, Neumarker, & Winkler Metzke, 2008) and the negative impacts on psychosocial development such as a loss of education, reduced peer socialization, negative effect on identity development and self-efficacy (Gowers et al., 2000; Meads, Gold, & Burls, 2001; Strober, Freeman, & Morrell, 1997). In addition, inpatient care has an associated emotional and financial burden for caregivers (Hillege, Beale, & McMaster, 2006; Toulany et al., 2015), as well as being substantially more expensive for the health system than outpatient care (Byford et al., 2007; Gowers et al., 2010).
Though not remitted by the end of the original RCT treatment protocol, most families continued with additional sessions of FBT. There are a number of potential explanations for this. By session 20, those who continued FBT had a significantly higher EBW than those who chose alternative treatments, and perhaps parents perceived this as positive change, and were thus motivated to continue for a longer period with FBT compared to the Alternate Treatment Gp. In addition, the dominant model of care provided by the treatment team was manualized FBT, and while the final decision on care was made by the family, the team’s familiarity and confidence with FBT may well have impacted upon the families decision. Similarly, as families made the final decision about treatment, those who opted for the alternative may have been motivated to cease FBT because of difficult to resolve barriers they perceived in their adolescent or the family system, and they thought that ongoing FBT strategies would not address these successfully.
In considering the above findings it is important to note that adolescents in the Alternative Treatment Gp were at a significantly lower weight than the Continue FBT Gp at the end of session 20 of FBT. While this may be an indicator of greater pathology, there was no significant difference in eating disorder psychopathology between the two groups at session 20 as measured by the EDE, no significant differences between the two groups at baseline and no significant difference in early treatment response as measured by weight gain at session four of FBT, making it difficult to predict who was going to respond in these groups over time.
Recent evidence suggests that additional FBT sessions, early in phase 1, to improve parental re-feeding skills improve rates of remission in adolescents with poor early weight gain (Lock et al., 2015). Our study suggests that additional FBT sessions, beyond current treatment manual recommendations, convey a similar benefit if there has been at least moderate weight progress by session 20.
The strength of this study was the application of FBT to a group of patients with high levels of eating disorder psychopathology who were severely unwell and medically unstable at baseline. This differentiates them from other published FBT studies (Brownstone, Anderson, Beenhakker, Lock, & Le Grange, 2012; Eisler et al., 2000; Lock et al., 2005; Lock et al., 2010), making their outcome and progress of particular interest. In addition, all participants were retained in the study to 12-month follow-up, and FBT fidelity was confirmed by an author of the treatment manual.
A limitation of this study was the post hoc design and lack of randomization. As a result the uneven groups and the large variance in some parameters impacted statistical outcomes. While these limitations are common with naturalistic studies, randomization was not possible, as groups were formed based on clinical outcome.
A substantial number of adolescent AN patients fail to experience remission following the current recommended dose of manualized FBT. Augmentations to improve remission rates are needed. Additional FBT sessions are a potentially useful strategy to improve rates of remission in patients who do not respond to the recommended number of sessions in the FBT treatment manual if there has been a moderate indication of treatment response. In addition, extra FBT sessions appear to reduce the need for hospitalization in this same group of patients, dramatically reducing costs and providing more opportunity for patients to meet their adolescent developmental needs. This may help ameliorate moving into a more chronic pattern of AN.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
