Randomized Controlled Trial of Starship Rescue: A Cognitive Behavior Therapy and Biofeedback-Based Computer Game to Treat Anxiety in Children and Young People with Long-Term Physical Conditions

Abstract

Objectives:

This study was undertaken to investigate the comparative efficacy of a cognitive behavior therapy and biofeedback-based computer game (Starship Rescue: Vortex of Anxiety [SRVA]) and placebo well-being-focused computer game (Starship Rescue: Voyage of Wellness) for reducing symptoms of anxiety and improving quality of life among children and young people aged 8–18 with long-term physical conditions (LTPCs).

Materials and Methods:

A randomized controlled trial was conducted with 60 participants (30 per arm). Primary outcomes were change in anxiety symptoms on the Generalized Anxiety Disorder 7-item (GAD-7) and Spence Children’s Anxiety Scale (SCAS) at 4 weeks. Secondary outcomes were changes in anxiety symptoms at 3 months; changes in quality of life using the Pediatric Quality of Life Inventory (PedsQL) at 4 weeks and 3 months; and acceptability of SRVA recorded at 4 weeks.

Results:

Participants in both groups experienced reduced anxiety (from a moderate to mild level) and improved quality of life at 4 weeks and 3 months. There were no significant group differences or time-by-group interactions observed for GAD-7, SCAS, or PedsQL. While SRVA was broadly acceptable, some suggestions for improvement of content and design were provided by users.

Conclusions:

Although this is the second study to demonstrate that SRVA can reduce levels of anxiety in children and young people with LTPC, previous questions regarding its efficacy and component-related benefits and new questions regarding the clinical value of physical health-oriented eHealth interventions remain unanswered. Further research is needed before SRVA can be recommended for clinical use.

Keywords

anxiety cognitive behavior therapy biofeedback

Introduction

Long-term physical conditions (LTPCs), defined as those that last more than 3 months and impair functioning,¹ include asthma, diabetes, epilepsy, and obesity, and affect 10%–12% of all children and young people.² The prevalence of LTPC among this age group is increasing globally, and in some developed countries, due to improvements in hygiene, immunization, and access to medical care, it is now greater than that of acute illness.^3,4

Psychological problems occur more frequently among children and young people with LTPC.⁵ Anxiety disorders have been identified in up to 40% of this group, related to young people’s developmentally linked internal ability to manage stress, family factors, and the cumulative allostatic load-related impact of illness and treatment, particularly distress and pain.^6,7 Anxiety disorders can occur during or even following the completion of medical (e.g., cancer) treatment and may be associated with school absence, poor academic performance, and lower health-related quality of life.^8–10 Left untreated, anxiety disorders tend to have a chronic and unremitting course and to increase the risk for adult psychiatric disorders, including depression and substance use disorders.^11,12

Access to, and efficacy of, treatments for psychological problems among children and young people with LTPC are currently limited. When available, anxiety in this group is usually addressed with psychotherapies designed for the general population, such as cognitive behavior therapy (CBT) and pharmacotherapy (e.g., anxiolytic or antidepressant medication). Currently, there is limited evidence that these therapies are effective for children with LTPC.¹³ Additionally, around 40%–50% of children and young people with anxiety show inadequate treatment response to CBT,¹⁴ suggesting there is room for improving current treatment both for the general population and, more specifically, for children and young people with LTPC.

With the increasing popularity of smart technology among “digitally native” young people and the release of app-based interventions, international organizations such as The Lancet Global Mental Health Group have called for the introduction of innovative and accessible cognitive and behavioral strategies to treat anxiety, depression, and other common mental health problems. eHealth (also known as digital health) interventions may have a useful role to play in addressing common mental health problems in children and young people, including those with LTPC.¹⁵ Game-based, CBT-oriented eHealth interventions such as SPARX (New Zealand) have been shown to be as good as face-to-face treatment for addressing adolescent depression,¹⁶ and others such as BRAVE online (Australia) have been shown to improve general, but not health-related, anxiety.¹⁷ A previous study by our group found openness among New Zealand children and young people with LTPC, their families, and clinicians to accessing anxiety management strategies via digital means.¹⁸

Traditional psychological therapies often include a component of psychologically or chemically induced relaxation. There is increasing evidence that newer, more technologically based forms of therapy such as biofeedback may achieve similar results, either alone or in combination with traditional therapies.¹⁹ Biofeedback involves the use of electrical or electromechanical equipment to measure physiological processes occurring in a person and then feed this information back to them to develop a greater awareness and ability to control changes within their bodies with, then without, equipment and to improve health and performance.^20,21 There are a number of types of biofeedback including heart rate variability (HRV), electroencephalography, and pneumography. A recent systematic review supported further research into HRV-based biofeedback as a treatment for anxiety in children and young people with LTPC.²²

Starship Rescue: Vortex of Anxiety (SRVA) is a relatively new CBT, biofeedback, and game-based eHealth intervention for treating anxiety in children and young people with LTPC that was codesigned with this group in New Zealand.²³ During a single-arm open trial of the game with 24 children and young people aged 10–18, it was found to be acceptable to users and to improve symptoms of anxiety and quality of life.²⁴

This study was undertaken to: 1.

Investigate the comparative efficacy of SRVA and a placebo eHealth game at (i) reducing anxiety and (ii) improving quality of life in children and young people aged 8–18 with LTPC.

Confirm the acceptability of SRVA with a larger audience.

Methods

Research strategy

A mixed methods approach was employed.

Participants

Sixty children and young people aged between 8 and 18 years who were living in New Zealand, had a LTPC of over 3 months’ duration, and were experiencing anxiety symptoms above a designated threshold (Generalized Anxiety Disorder Scale or GAD-7 score >5) were recruited for the study. Eligible participants could be of any ethnicity, did not have any comorbid mental health conditions, were intellectually and physically able to use the eHealth intervention, and able to provide informed consent or assent. Individuals were excluded if they had recently undertaken or were undertaking CBT, biofeedback therapy, or pharmacotherapy with anxiolytic medication that might conflate study results.

Study design

A randomized controlled trial (RCT) was undertaken to evaluate the effectiveness of SRVA in comparison with Starship Rescue: Voyage of Wellness (SRVW), a placebo, eHealth, game-based intervention designed for improving nutrition and physical activity. Following trial registration (ACTRN12621001391864 on October 15, 2021), participants were recruited via clinicians at three New Zealand District Health Boards (public-funded health services) and via caregivers during a social media advertising campaign. Individual and caregiver-targeted advertisements to Facebook groups and pages were used to ensure adequate recruitment of New Zealand Māori children and young people. Individuals who expressed interest were contacted by a member of the research team (H.K.) and provided with study information and consent forms for completion by young people (if aged over 16) or their caregivers (if aged under 16). Thirty participants were electronically randomized by H.K. to each arm (research randomizer, blocks of ten). Only participants were blinded to treatment allocation during the study. All participants were loaned a tablet with the intervention or control game loaded on it and encouraged to play the game at a rate of their choice over 4–6 weeks. Baseline, 4-week, and 3-month quantitative outcome data and demographic data (such as age, sex, ethnicity, and type of LTPC) were collected via REDCap®. Qualitative feedback was collected via an online survey at 3 months. Participants in the control group were not offered the experimental game after the completion of the study. On exit from the study (at any stage), all participants were provided with a NZ $20 (US $15) gift voucher. To ensure the safety of Māori participants, all questionnaires had previously been used with and validated with Māori young people, family (whānau) involvement was encouraged prior to recruitment, and the study was conducted under the guidance of the Māori elder (Kaumātua) at a local Māori mental health service.

Intervention and placebo games

SRVA is a five-module, CBT and biofeedback-based computer game, codesigned with New Zealand children and young people with LTPCs. Each module contains strategies and techniques embedded within the game, including psychoeducation about anxiety, relaxation, cognitive restructuring, and graded exposure to help with anxiety.²³ Participants were encouraged to use these strategies and apply what they learned in real life. The game is designed to be played on a tablet along with the use of a synchronized wrist-based Scoche® heart rate monitor. The placebo game SRVW also has five modules with similar imagery but is focused on nutrition and physical activity. It does not include any obvious mental health content or use of a heart rate monitor. A summary of modules in both interventions is presented in Table 1.

Table 1.

Summary of SRVA and SRVW Modules

	SRVA	SRVW
Module 1	Introduction to anxiety, its origins and symptoms	Introduction to well-being and how it may be improved by different means
Module 2	Using the body to beat anxiety—deep breathing, progressive muscle relaxation	Using exercise to improve well-being
Module 3	Using the mind to beat anxiety—recognizing helpful and unhelpful thoughts, prioritizing the former	Using healthy eating to improve well-being
Module 4	Using actions to beat anxiety—problem solving, graded exposure. Includes out of game task to address one type of fear/worry/source of anxiety	Sleep hygiene strategies for improving well-being
Module 5	Quiz to consolidate learning	Quiz to consolidate learning

SRVA, Starship Rescue: Vortex of Anxiety; SRVW, Starship Rescue: Voyage of Wellness.

Outcome measures

Change in anxiety was evaluated using the Generalized Anxiety Disorder 7-item (GAD-7) and Spence Children’s Anxiety Scale (SCAS). The GAD-7 is a short 7-item, self-reported scale for measuring anxiety in people aged 13 years and over. Results are categorized into mild, moderate, and severe levels of anxiety. It has good internal consistency (α = 0.89), reliability and sensitivity (89%), and specificity (82%).^25,26 The SCAS is a well-validated 46-item self-report scale measuring child anxiety via an overall score and six subscales for panic or agoraphobia, social phobia, separation anxiety, obsessions/compulsions, fear of physical injury, and generalized anxiety in people aged 8–15. It has psychometric properties with a mean internal consistency reported at (α = 0.92) for the total score.²⁷ Quality of life was evaluated using the Pediatric Quality of Life Inventory (PedsQL).²⁸ The PedsQL is a well-validated 23-item self- or parent-report scale measuring quality of life. It has good internal consistency (α = 0.88) for the total scale, validity, and acceptability. The scale assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents. Acceptability of SRVA was evaluated at 3-month follow-up using a brief online questionnaire including questions about game completion, participant likes and dislikes, and suggestions for intervention improvement.

Statistical methodology

Quantitative data were collected via REDCap and de-identified prior to extraction. De-identified data were analyzed using Microsoft Excel and IBM SPSS Statistics Version 28.0. Based on the open trial results, the power calculation established a minimum sample size of N = 25 per arm to detect statistically significant differences between groups (α = 0.05) with 80% power. As such, a total of 30 participants were recruited for each arm, allowing for attrition. Demographic data were analyzed using descriptive statistics, and group changes in anxiety over time were analyzed using linear mixed models (for repeated measures). Intention-to-treat analysis was undertaken. A P value of <0.05 was taken into consideration to indicate statistical significance, and 95% confidence intervals were used to establish the extent of differences between pre- and postmeasures. Qualitative data were analyzed by H.K. and H.T. using content analysis, an approach that is well suited for focus groups or interviews where predetermined concepts or categories are examined, and any disagreements were resolved by consensus.²⁹

Ethical issues

Ethics approval for the study was obtained from the New Zealand Health and Disability Ethics Committee (HDEC reference: 21/STH/102). Locality approval for recruitment via clinicians was obtained from three New Zealand District Health Boards (DHBs, not named for reasons of confidentiality) between May and September 2020. Invitations to participate in the study were forwarded to potential participants through their own clinicians or via caregivers to minimize coercion. Verbal and written consent was obtained directly from participants over 16 years old, and paired assent from parents and young persons for participants aged under 16 years via REDCap. Participants were informed that they were free to discontinue participation in the trial at any stage, without any consequence. Although plans were made to address any unanticipated distress during trial participation by the consult liaison mental health service at one DHB (of which H.T. is a team member), no participants required referral to this service. All data were stored in a de-identified manner and have been securely stored on a University server or in secure filing cabinets for 10 years (or 10 years following participants’ 16th birthday) as per ethics committee recommendations.

Patient and public involvement

Although the intervention of interest (SRVA) was codesigned with New Zealand young people,²³ no young people were involved in the development or conceptualization of the research study itself.

Results

Participant characteristics

Of the 1606 individuals who expressed interest, the first 60 participants who met the eligibility criteria, provided informed consent, and completed baseline measures were recruited for the study between August 2021 and May 2022. All 60 participants were recruited from Facebook, as study investigators from the two hospital sites (ADHB and CMDHB) were unable to refer or find interested or eligible participants, apart from one young person who was referred from CMDHB. However, this young person did not respond to contact from the research team. The total participant sample age ranged between 8 and 18 years, with a mean age of 13.0 years (standard deviation [SD] 3.2). The number of female (31; 52%) and male (28; 47%) participants was relatively similar, with one participant (3%) identifying as nonbinary. Two participants in the intervention group and one participant in the control group exited the study before 4 weeks due to competing demands (reasons provided). A further four in the intervention group and eight in the control group were lost to follow-up by 4 weeks. None of the recruited participants dropped out between 4 weeks and 3 months. Further details are presented in the Consolidated Standards for Reporting Trials flow diagram (Fig. 1). Characteristics of included participants are summarized in Table 2.

FIG. 1.

CONSORT 2010 flow diagram. CONSORT, Consolidated Standards for Reporting Trials.

Table 2.

Participant Demographic Characteristics

	Starship Rescue: Vortex of anxiety	Starship Rescue: Voyage of wellness
Number of participants	30	30
Age (years); mean (range)	13.8 (8–18)	12.3 (8–18)
Sex
Female	17 (56%)	14 (47%)
Male	12 (40%)	16 (53%)
Nonbinary	1 (3%)
Ethnicity
Māori	11 (36%)	10 (33%)
New Zealand European	11 (36%)	17 (56%)
Pacific		2 (7%)
Asian	3 (10%)	1 (3%)
European	2 (7%)
MELAA	3 (10%)

MELAA, Middle Eastern, Latin American, African.

Efficacy

Participants in both the experimental and control groups experienced reduced anxiety (from a moderate to mild level) and improved quality of life over time. There were no significant group differences or time-by-group interactions observed for GAD-7, SCAS, or PedsQL (Table 3). There were no significant subgroup differences by age, sex, or ethnicity (Supplementary Tables S1, S2 and S3).

Table 3.

Change in Outcomes Over Time

Outcome	Starship Rescue: Vortex of anxiety	Starship Rescue: Voyage of wellness (control)	Marginal mean difference Starship Rescue: Vortex of anxiety versus control	P	Effect size
Outcome	Mean (SD)	Mean (SD)	Mean (95% CI)	P	Effect size
Generalized anxiety disorder 7-item (GAD-7)
Baseline	14.06 (3.77)	12.53 (4.45)	1.53 (12.24–14.37)
Improvement from baseline to 4 weeks	5.19 (6.18)	4.32 (6.18)	0.87 (−2.61 to 4.35)	0.617	0.141
Improvement from baseline to 3 months	4.54 (4.61)	4.62 (4.61)	−0.07 (−2.69 to 2.55)	0.955	−0.015
Spence Children’s Anxiety Scale (SCAS)
Baseline	58.80 (17.88)	53.60 (19.32)	5.2 (−4.42 to 14.82)
Improvement from baseline to 4 weeks	17.08 (20.4)	13.5 (20.4)	3.58 (−8.27 to 15.43)	0.546	0.175
Improvement from baseline to 3 months	19.68 (19.18)	16.92 (19.18)	2.22 (−8.14 to 13.66)	0.613	0.144
Pediatric Quality of Life Inventory (PedsQL)
Baseline	48.44 (13.01)	49.13 (17.44)	−0.69 (44.81–52.76)
Improvement from baseline to 4 weeks	7.93 (16.6.7)	8.15 (16.67)	−0.23 (−9.91 to 9.46)	0.963	−0.0138
Improvement from baseline to 3 months	8.47 (12.41)	10.42 (12.41)	−1.95 (−9.16 to 5.26)	0.589	−0.157

CI, confidence interval; SD, standard deviation.

Acceptability

All but one participant in the intervention (SRVA) group completed the whole game. Most participants in this group provided positive feedback about its content (“It taught me new things about how to control my anxiety”) and process (“That I could do at my own pace”). Some participants found the game to be too childish for them (“It seemed to cater much more to younger ages”), and a few experienced technical difficulties (“Some games were frustrating because of the controls”; “It kept turning off when I wasn’t active”). The latter issues were similar for participants in the control group, which is not surprising considering the cartoon-based visual imagery and format of SRVW were as similar as possible to SRVA. Suggestions for improvement of SRVA varied, with some participants wanting modules to be longer and others wanting them to be shorter.

Discussion

SRVA appears to be a broadly acceptable CBT and biofeedback-based intervention for the management of anxiety among children and young people with LTPC. While users of SRVA and the control intervention SRVW experienced improvements in anxiety and quality of life at 4-week and 3-month follow-up, outcome differences between groups did not reach statistical significance at either time point. This may be due to the interventions themselves or our study design.

A handful of CBT-based eHealth interventions, namely, BRAVE online,³⁰ Think Feel Do,³¹ Cool Teens,³² and Camp Cope-A-Lot,³³ have previously been shown to be efficacious at reducing symptoms of anxiety, with effects sustained at 3- to 12-month follow-up. The clinically meaningful shift from a moderate to mild level of anxiety observed during our study was similar to that seen in studies of these eHealth interventions and out of keeping with knowledge about the natural history of anxiety disorders. Around two-thirds of young people with generalized anxiety disorder have previously been shown to experience persistent symptoms at 1-year follow-up.³⁴ RCTs of BRAVE online, Think Feel Do, and Cool Teens were all conducted without the use of active controls, which might account for group-based differences in outcomes being more evident in these studies than ours.

Head-to-head studies of Camp Cope-A-Lot and BRAVE online versus face-to-face CBT have previously revealed similar levels of improvement between eHealth and non-eHealth therapies, suggesting the clinical validity of both and potential cost savings with the former approach. No RCTs of eHealth interventions for childhood anxiety versus nonmental health-related interventions have ever been conducted. Despite our best attempt to develop a control intervention that looked the same and functioned the same as SRVA without the active ingredients of anxiety treatment, it is possible that the diet- and activity-focused intervention we designed did indeed have an anxiolytic effect. Exploring the literature, physical activity has previously been shown to reduce anxiety,³⁵ and there is mixed evidence for the effect of dietary interventions. While a study of Iranian adults found that participants with a higher healthy eating index had a lower likelihood of developing anxiety,³⁶ a review by Opie et al. (2015) found that dietary interventions were not associated with improved anxiety in 8 out of 10 included studies.³⁷ If we did inadvertently develop a second intervention for reducing anxiety, this would be similar to previous researchers who found that, despite being a control intervention, interpersonal therapy was a valid treatment for depression during an RCT of CBT and warrants further investigation.³⁸ A final possibility is that placebo effects, which have previously been shown to be less of an issue with studies of anxiety versus depression treatments, may nonetheless have played a role.^39,40

Although this study was powered to ascertain the efficacy of SRVA as a whole based on the power calculation used for our open trial and in keeping with numbers recruited for RCTs of similar eHealth interventions,⁴¹ it may have actually been underpowered to detect treatment effects during an RCT, especially given potential confounding placebo or indirect anxiety-reducing effects of SRVW. This makes it hard to know if the differences between our study groups were related to the ineffectiveness of SRVA or due to insufficient sample size for detecting significant effects. The overall small effect size and lack of significant difference between groups raise the possibility that observed differences are attributable to nonspecific effects such as placebo or greater engagement with either game. Prior research has shown that participants experience improvements simply from being involved in an intervention, regardless of its specific content. This is all the more likely when active engagement is involved.⁴² Conversely, it is possible that a Type II error may have occurred, leading us not to detect SRVA’s true effect. Despite the lack of group differences in this study, it is possible that SRVA may be clinically beneficial for some subgroups of children and young people. Unfortunately, within our limited sample, we were not able to identify any demographic or baseline characteristics that were associated with greater treatment effects. Finally, the dropout rate in our study may have introduced bias, for instance, by more anxious participants being more likely to exit the study early, and those remaining providing an underestimate of SRVA’s true effect.

Based on the number of recruited participants, it was not possible to discern the relative benefits or otherwise of its CBT and biofeedback-based components. We note that recent studies of similar hybrid interventions have revealed mixed results in young people without LTPC and in adults with LTPC. Mindlight, an online, game-based anxiety reduction and biofeedback-based intervention, led to greater improvement than online CBT in young people without LTPC⁴³; a combination of face-to-face CBT and biofeedback for panic disorder did not lead to any greater improvement in anxiety symptoms than treatment as usual⁴⁴; and a study of face-to-face CBT versus biofeedback for adults with fibromyalgia found greater improvement in cognitive symptoms with CBT and physical symptoms with biofeedback.⁴⁵ So, the component-related benefits of SRVA remain of interest. Despite not being able to explore the relative effects of CBT and biofeedback, we note that there are multiple possible mechanisms by which CBT and biofeedback may interact to treat anxiety. These include complementary mechanisms such as CBT, enhancing the effect of biofeedback by altering cognitive patterns and beliefs about stress and anxiety. Previous research has shown that CBT can improve the interpretation of physiological signals, potentially making biofeedback more effective.⁴⁶ Sequential influences may also be relevant, with biofeedback serving as a practical application of cognitive strategies taught during CBT. By providing real-time feedback on physiological states, biofeedback may reinforce cognitive techniques learned in CBT, allowing users to better apply these strategies in real-life situations.⁴⁷ Benefits of CBT and biofeedback may also vary across participant subgroups, with individuals with higher levels of anxiety benefiting more from CBT and those with more physiological symptoms finding biofeedback more beneficial. This would be in keeping with findings from a review by Litz et al. (2019), which found that individual differences could significantly influence treatment outcomes.⁴⁸ Finally, integrative effects that involve appraisal, interoceptive awareness, operant learning, and physiological changes may explain effects on anxiety.⁴⁹

The scales used in our study may also have affected our results. The GAD-7 scale, chosen for brevity, has only been validated in people over 13 and, as such, may have been less reliable in our population, affecting both the accuracy of measurement and outcomes. Fortunately, the longer and more comprehensive SCAS, which captures different aspects of anxiety, has been validated for people over 8, and the use of both measures can be complementary.

Strengths of this study include the inclusion of children and young people with a range of LTPCs, engagement of Māori participants being proportional to the general population, use of an active comparator intervention, and a high retention rate in both arms. Limitations include the unavailability of objective measures of intervention use and duration, inability to discern between the benefits of CBT and biofeedback components of SRVA, use of unreliable outcome measures, lack of collection of LTPC-specific or anxiety disorder-specific outcomes, and nongeneralizability to children and young people with LTPC outside of New Zealand. Although not powered to detect harm, no adverse events were reported during this study.

Future research should include a head-to-head comparison of SRVA and SRVW with other CBT-based eHealth interventions such as BRAVE online in children and young people with LTPC. Use of a third (waitlist) control arm would also be useful to discern intervention versus time-related changes in symptoms. A more adequately powered study with refined methodology, appropriately validated outcome measures, and planned dropout analysis is also needed to evaluate overall outcomes and the relative benefits of CBT and biofeedback-based components of SRVA, as well as potential mechanisms by which these may interact. A collection of objective module completion and intervention use (duration and frequency) would further increase understanding of the factors that lead to optimal outcomes. So would the inclusion of a heart rate monitor for use with the placebo intervention. Although SRVA was designed as a user-driven intervention, regular check-ins by a researcher or caregiver may help to reduce dropouts and, as such, be worth investigating. Exploration of the potential benefits of physically focused eHealth interventions on anxiety would also be useful, and this should be done in comparison with established online CBT interventions. As recruitment via clinical services proved challenging, albeit in the context of the COVID-19 pandemic, it might be useful to prioritize online recruitment during future studies of children and young people with LTPCs.

Conclusions

During this RCT, there was no difference in outcomes between young people with LTPC who used a CBT and biofeedback-based SRVA and a placebo eHealth intervention SRVW. Although this is the second study to demonstrate that SRVA can reduce levels of anxiety in children and young people with LTPC, previous questions regarding its efficacy and component-related benefits and new questions regarding the clinical value of physical health-oriented eHealth interventions remain unanswered. Further research is needed before SRVA can be recommended for clinical use.

Footnotes

Acknowledgments

The authors wish to acknowledge all the participants who took part in this study. The authors also wish to acknowledge the generous support of the Athlae Lyon Starship Research Trust for funding the study and Cure Kids for funding S.M.’s participation.

Author Disclosure Statement

H.T., S.M., K.S., and T.N. are all codevelopers of SRVA and SRVW interventions. H.K., C.F., and T.N. do not have any conflicts of interest to declare.

Funding Information

This study was funded by the Athlae Lyon Starship Research Trust, and S.M.’s participation was funded by Cure Kids.

Supplemental Material

References

Van Der Lee

, Mokkink

, Grootenhuis

, et al. Definitions and measurement of chronic health conditions in childhood: A systematic review. JAMA, 2007; 297(24):2741–2751; doi: 10.1001/jama.297.24.2741

Eiser

. Effects of chronic illness on children and their families. Adv Psychiatr Treat, 1997; 3(4):204–210; doi: 10.1192/apt.3.4.204

Perrin

, Bloom

, Gortmaker

. The increase of childhood chronic conditions in the United States. JAMA, 2007; 297(24):2755–2759; doi: 10.1001/jama.297.24.2755

Halfon

, Newacheck

. Evolving notions of childhood chronic illness. JAMA, 2010; 303(7):665–666; doi: 10.1001/jama.2010.130

Perrin

, Gnanasekaran

, Delahaye

. Psychological aspects of chronic health conditions. Pediatr Rev, 2012; 33(3):99–109; doi: 10.1542/pir.33-3-99

Juster

, McEwen

, Lupien

. Allostatic load biomarkers of chronic stress and impact on health and cognition. Neurosci Biobehav Rev, 2010; 35(1):2–16; doi: 10.1016/j.neubiorev.2009.10.002

Lewis

, Vitulano

. Biopsychosocial issues and risk factors in the family when the child has a chronic illness. Child Adolesc Psychiatr Clin N Am, 2003; 12(3):389–399, v; doi: 10.1016/s1056-4993(03)00024-5

Sawyer

, Antoniou

, Toogood

, et al. Childhood cancer: A two-year prospective study of the psychological adjustment of children and parents. J Am Acad Child Adolesc Psychiatry, 1997; 36(12):1736–1743; doi: 10.1097/00004583-199712000-00022

Greenberg

, Sisitsky

, Kessler

, et al. The economic burden of anxiety disorders in the 1990s. J Clin Psychiatry, 1999; 60(7):427–435; doi: 10.4088/jcp.v60n0702

10.

Opolski

, Wilson

. Asthma and depression: A pragmatic review of the literature and recommendations for future research. Clin Pract Epidemiol Ment Health, 2005; 1:18; doi: 10.1186/1745-0179-1-18

11.

Ramsawh

, Raffa

, Edelen

, et al. Anxiety in middle adulthood: Effects of age and time on the 14-year course of panic disorder, social phobia and generalized anxiety disorder. Psychol Med, 2009; 39(4):615–624; doi: 10.1017/S0033291708003954

12.

Pine

, Cohen

, Gurley

, et al. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry, 1998; 55(1):56–64; doi: 10.1001/archpsyc.55.1.56

13.

Bennett

, Shafran

, Coughtrey

, et al. Psychological interventions for mental health disorders in children with chronic physical illness: A systematic review. Arch Dis Child, 2015; 100(4):308–316; doi: 10.1136/archdischild-2014-307474

14.

Compton

, Peris

, Almirall

, et al. Predictors and moderators of treatment response in childhood anxiety disorders: Results from the CAMS trial. J Consult Clin Psychol, 2014; 82(2):212–224; doi: 10.1037/a0035458

15.

Chisholm

, Flisher

, Lund

, et al.; Lancet Global Mental Health Group. Scale up services for mental disorders: A call for action. Lancet, 2007; 370(9594):1241–1252; doi: 10.1016/S0140-6736(07)61242-2

16.

Merry

, Stasiak

, Shepherd

, et al. The effectiveness of SPARX, a computerized self help intervention for adolescents seeking help for depression: Randomized controlled non-inferiority trial. Bmj, 2012; 344:e2598; doi: 10.1136/bmj.e2598

17.

Holmes

, March

, Spence

. Use of the internet in the treatment of anxiety disorders with children and adolescents. Couns Psychother Health, 2009; 5(1):187–231.

18.

Thabrew

, Stasiak

, Garcia‐Hoyos

, et al. Game for health: How eHealth approaches might address the psychological needs of children and young people with long‐term physical conditions. J Paediatr Child Health, 2016; 52(11):1012–1018; doi: 10.1111/jpc.13271

19.

Schoenberg

, David

. Biofeedback for psychiatric disorders: A systematic review. Appl Psychophysiol Biofeedback, 2014; 39(2):109–135; doi: 10.1007/s10484-014-9246-9

20.

Culbert

, Kajander

, Reaney

. Biofeedback with children and adolescents: Clinical observations and patient perspectives. J Dev Behav Pediatr, 1996; 17(5):342–350; doi: 10.1097/00004703-199610000-00009

21.

Schwartz

. Intake decisions and preparation of patients for therapy. In: Biofeedback: A practitioner’s guide ( Schwartz

, Andrasik

, eds). The Guilford Press, New York, NY; 2003; pp: 105–127.

22.

Thabrew

, Ruppeldt

, Sollers

. Systematic review of biofeedback interventions for addressing anxiety and depression in children and adolescents with long-term physical conditions. Appl Psychophysiol Biofeedback, 2018; 43(3):179–192; doi: 10.1007/s10484-018-9399-z

23.

Thabrew

, Stasiak

, Merry

. Protocol for co-design, development, and open trial of a prototype game-based ehealth intervention to treat anxiety in young people with long-term physical conditions. JMIR Res Protoc, 2017; 6(9):e171; doi: 10.2196/resprot.7250

24.

Thabrew

, Stasiak

, Kumar

, et al. A cognitive behavioral Therapy–, Biofeedback-, and game-based eHealth intervention to treat anxiety in children and Young People with Long-Term Physical Conditions (Starship Rescue): Co-design and Open Trial. JMIR Serious Games, 2021; 9(3):e26084; doi: 10.2196/26084

25.

Spitzer

, Kroenke

, Williams

, et al. A brief measure for assessing generalized anxiety disorder: The GAD-7. Arch Intern Med, 2006; 166(10):1092–1097; doi: 10.1001/archinte.166.10.1092

26.

Löwe

, Decker

, Müller

, et al. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care, 2008; 46(3):266–274; doi: 10.1097/MLR.0b013e318160d093

27.

Orgilés

, Fernández-Martínez

, Guillén-Riquelme

, et al. A systematic review of the factor structure and reliability of the Spence Children’s Anxiety Scale. J Affect Disord, 2016; 190:333–340; doi: 10.1016/j.jad.2015.09.055

28.

Varni

, Seid

, Kurtin

. PedsQL™ 4.0: Reliability and validity of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in healthy and patient populations. Med Care, 2001; 39(8):800–812; doi: 10.1097/00005650-200108000-00006

29.

Hsieh

, Shannon

. Three approaches to qualitative content analysis. Qual Health Res, 2005; 15(9):1277–1288; doi: 10.1177/1049732305276687

30.

March

, Spence

, Donovan

. The efficacy of an internet-based cognitive-behavioral therapy intervention for child anxiety disorders. J Pediatr Psychol, 2009; 34(5):474–487; doi: 10.1093/jpepsy/jsn099

31.

Stallard

, Richardson

, Velleman

, et al. Computerized CBT (Think, Feel, Do) for depression and anxiety in children and adolescents: Outcomes and feedback from a pilot randomized controlled trial. Behav Cogn Psychother, 2011; 39(3):273–284; doi: 10.1017/S135246581000086X

32.

Wuthrich

, Rapee

, Cunningham

, et al. A randomized controlled trial of the Cool Teens CD-ROM computerized program for adolescent anxiety. J Am Acad Child Adolesc Psychiatry, 2012; 51(3):261–270; doi: 10.1016/j.jaac.2011.12.002

33.

Khanna

, Kendall

. Computer-assisted cognitive behavioral therapy for child anxiety: Results of a randomized clinical trial. J Consult Clin Psychol, 2010; 78(5):737–745; doi: 10.1037/a0019739

34.

Voltas

, Hernández-Martínez

, Arija

, et al. The natural course of anxiety symptoms in early adolescence: Factors related to persistence. Anxiety Stress Coping, 2017; 30(6):671–686; doi: 10.1080/10615806.2017.1347642

35.

Anderson

, Shivakumar

. Effects of exercise and physical activity on anxiety. Front Psychiatry, 2013; 4:27; doi: 10.3389/fpsyt.2013.00027

36.

Saneei

, Hajishafiee

, Keshteli

, et al. Adherence to Alternative Healthy Eating Index in relation to depression and anxiety in Iranian adults. Br J Nutr, 2016; 116(2):335–342; doi: 10.1017/S0007114516001926

37.

Opie

, O’Neil

, Itsiopoulos

, et al. The impact of whole-of-diet interventions on depression and anxiety: A systematic review of Randomized controlled trials. Public Health Nutr, 2015; 18(11):2074–2093; doi: 10.1017/S1368980014002614

38.

Klerman

, Dimascio

, Weissman

, et al. Treatment of depression by drugs and psychotherapy. Am J Psychiatry, 1974; 131(2):186–191; doi: 10.1176/ajp.131.2.186

39.

Cohen

, Deniau

, Maturana

, et al. Are child and adolescent responses to placebo higher in major depression than in anxiety disorders? A systematic review of placebo-controlled trials. PLoS One, 2008; 3(7):e2632; doi: 10.1371/journal.pone.0002632

40.

Kirsch

. Placebo effect in the treatment of depression and anxiety. Front Psychiatry, 2019; 10:407; doi: 10.3389/fpsyt.2019.00407

41.

Spence

, Donovan

, March

, et al. A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety. J Consult Clin Psychol, 2011; 79(5):629–642; doi: 10.1037/a0024512

42.

Benedetti

, Amanzio

. The placebo response: How words and rituals change the patient’s brain. Patient Educ Couns, 2011; 84(3):413–419; doi: 10.1016/j.pec.2011.04.034

43.

Tsui

, DeFrance

, Khalid-Khan

, et al. Reductions of anxiety symptoms, state anxiety, and anxious arousal in youth playing the videogame MindLight compared to online cognitive behavioral therapy. Games Health J, 2021; 10(5):330–338; doi: 10.1089/g4h.2020.0083

44.

, Chang

, Lee

, et al. The psychological and physiological effects of integrated cognitive-behavioral and biofeedback therapy on panic disorder: A randomized controlled trial. J Formos Med Assoc, 2023; 122(12):1305–1312; doi: 10.1016/j.jfma.2023.07.007

45.

Govillard

, Gorbeña

, Iraurgi

. Cognitive behavioral therapy with and without biofeedback in fibromyalgia: Assessment of functional and clinical change. Health Psychol Open, 2022; 9(1):20551029221106044; doi: 10.1177/20551029221106044

46.

Hofmann

, Asnaani

, Vonk

, et al. The efficacy of cognitive behavioral therapy: A review of meta-analyses. Cognit Ther Res, 2012; 36(5):427–440; doi: 10.1007/s10608-012-9476-1

47.

Goessl

, Curtiss

, Hofmann

. The effect of heart rate variability biofeedback training on stress and anxiety: A meta-analysis. Psychol Med, 2017; 47(15):2578–2586; doi: 10.1017/S0033291717001003

48.

Litz

, Berke

, Kline

, et al. Patterns and predictors of change in trauma-focused treatments for war-related posttraumatic stress disorder. J Consult Clin Psychol, 2019; 87(11):1019–1029; doi: 10.1037/ccp0000426

49.

Weerdmeester

, van Rooij

, Engels

, et al. An integrative model for the effectiveness of biofeedback interventions for anxiety regulation. J Med Internet Res, 2020; 22(7):e14958; doi: 10.2196/14958

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.21 MB

0.00 MB