A fully automated self-help biopsychosocial transdiagnostic digital intervention to reduce anxiety and/or depression and improve emotional regulation and well-being: pre-follow-up single-arm feasibility trial
- Klein, Britt, Nguyen, Huy, McLaren, Suzanne, Andrews, Brooke, Shandley, Kerrie
- Authors: Klein, Britt , Nguyen, Huy , McLaren, Suzanne , Andrews, Brooke , Shandley, Kerrie
- Date: 2023
- Type: Text , Journal article
- Relation: JMIR Formative Research Vol. 7, no. (2023), p.
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- Description: Background: Anxiety disorders and depression are prevalent disorders with high comorbidity, leading to greater chronicity and severity of symptoms. Given the accessibility to treatment issues, more evaluation is needed to assess the potential benefits of fully automated self-help transdiagnostic digital interventions. Innovating beyond the current transdiagnostic one-size-fits-all shared mechanistic approach may also lead to further improvements. Objective: The primary objective of this study was to explore the preliminary effectiveness and acceptability of a new fully automated self-help biopsychosocial transdiagnostic digital intervention (Life Flex) aimed at treating anxiety and/or depression, as well as improving emotional regulation; emotional, social, and psychological well-being; optimism; and health-related quality of life. Methods: This was a real-world pre-during-post-follow-up feasibility trial design evaluation of Life Flex. Participants were assessed at the preintervention time point (week 0), during intervention (weeks 3 and 5), at the postintervention time point (week 8), and at 1- and 3-month follow-ups (weeks 12 and 20, respectively). Results: The results provided early support for the Life Flex program in reducing anxiety (Generalized Anxiety Disorder 7), depression (Patient Health Questionnaire 9), psychological distress (Kessler 6), and emotional dysregulation (Difficulties in Emotional Regulation 36) and increasing emotional, social, and psychological well-being (Mental Health Continuum-Short Form); optimism (Revised Life Orientation Test); and health-related quality of life (EQ-5D-3L Utility Index and Health Rating; all false discovery rate [FDR] < .001). Large within-group treatment effect sizes (range |d|=0.82 to 1.33) were found for most variables from pre- to postintervention assessments and at the 1- and 3-month follow-up. The exceptions were medium treatment effect sizes for EQ-5D-3L Utility Index (range Cohen d=
- Authors: Klein, Britt , Nguyen, Huy , McLaren, Suzanne , Andrews, Brooke , Shandley, Kerrie
- Date: 2023
- Type: Text , Journal article
- Relation: JMIR Formative Research Vol. 7, no. (2023), p.
- Full Text:
- Reviewed:
- Description: Background: Anxiety disorders and depression are prevalent disorders with high comorbidity, leading to greater chronicity and severity of symptoms. Given the accessibility to treatment issues, more evaluation is needed to assess the potential benefits of fully automated self-help transdiagnostic digital interventions. Innovating beyond the current transdiagnostic one-size-fits-all shared mechanistic approach may also lead to further improvements. Objective: The primary objective of this study was to explore the preliminary effectiveness and acceptability of a new fully automated self-help biopsychosocial transdiagnostic digital intervention (Life Flex) aimed at treating anxiety and/or depression, as well as improving emotional regulation; emotional, social, and psychological well-being; optimism; and health-related quality of life. Methods: This was a real-world pre-during-post-follow-up feasibility trial design evaluation of Life Flex. Participants were assessed at the preintervention time point (week 0), during intervention (weeks 3 and 5), at the postintervention time point (week 8), and at 1- and 3-month follow-ups (weeks 12 and 20, respectively). Results: The results provided early support for the Life Flex program in reducing anxiety (Generalized Anxiety Disorder 7), depression (Patient Health Questionnaire 9), psychological distress (Kessler 6), and emotional dysregulation (Difficulties in Emotional Regulation 36) and increasing emotional, social, and psychological well-being (Mental Health Continuum-Short Form); optimism (Revised Life Orientation Test); and health-related quality of life (EQ-5D-3L Utility Index and Health Rating; all false discovery rate [FDR] < .001). Large within-group treatment effect sizes (range |d|=0.82 to 1.33) were found for most variables from pre- to postintervention assessments and at the 1- and 3-month follow-up. The exceptions were medium treatment effect sizes for EQ-5D-3L Utility Index (range Cohen d=
- Linardon, Jake, Shatte, Adrian, Messer, Mariel, McClure, Zoe, Fuller-Tyszkiewicz, Matthew
- Authors: Linardon, Jake , Shatte, Adrian , Messer, Mariel , McClure, Zoe , Fuller-Tyszkiewicz, Matthew
- Date: 2023
- Type: Text , Journal article
- Relation: Behavior Therapy Vol. 54, no. 2 (2023), p. 303-314
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- Description: It is unclear whether offering individuals a choice between different digital intervention programs affects treatment outcomes. To generate initial insights, we conducted a pilot doubly randomized preference trial to test whether offering individuals with binge-spectrum eating disorder a choice between two digital interventions is causally linked with superior outcomes than random assignment to these interventions. Participants with recurrent binge eating were randomized to either a choice (n = 77) or no-choice (n = 78) group. Those in the choice group could choose one of the two digital programs, while those in the no-choice group were assigned a program at random. The two digital interventions (a broad and a focused program) took 4 weeks to complete, were based on cognitive-behavioral principles and have demonstrated comparable efficacy, but differ in scope, content, and targeted change mechanisms. Most participants (79%) allocated to the choice condition chose the broad program. While both groups experienced improvements in primary (Eating Disorder Examination Questionnaire global scores and number of binge eating episodes over the past month) and secondary outcomes (dietary restraint, body image concerns, etc.), no significant between-group differences were observed. The two groups did not differ on dropout rates, nor on most indices of intervention engagement. Findings provide preliminary insights towards the role of client preferences in digital mental health interventions for eating disorders. Client preferences may not determine outcomes when digital interventions are based on similar underlying principles, although larger trials are needed to confirm this. © 2023
- Linardon, Jake, Shatte, Adrian, Rosato, John, Fuller-Tyszkiewicz, Matthew
- Authors: Linardon, Jake , Shatte, Adrian , Rosato, John , Fuller-Tyszkiewicz, Matthew
- Date: 2022
- Type: Text , Journal article
- Relation: Psychological Medicine Vol. 52, no. 9 (2022), p. 1679-1690
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- Description: Abstract Background Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial. Methods Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app ( n = 197) or waiting list ( n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress. Results Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test ( d = −0.80). Significant effects were also observed for secondary outcomes ( d 's = −0.30 to −0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%. Conclusion Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.
Efficacy of a digital mental health biopsychosocial transdiagnostic intervention with or without therapist assistance for adults with anxiety and depression : adaptive randomized controlled trial
- Andrews, Brooke, Klein, Britt, Nguyen, Huy, Corboy, Denise, McLaren, Suzanne, Watson, Shaun
- Authors: Andrews, Brooke , Klein, Britt , Nguyen, Huy , Corboy, Denise , McLaren, Suzanne , Watson, Shaun
- Date: 2023
- Type: Text , Journal article
- Relation: Journal of Medical Internet Research Vol. 25, no. (2023), p.
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- Description: Background: Digital mental health (DMH) interventions incorporating elements that adapt to the evolving needs of consumers have the potential to further our understanding of the optimal intensity of therapist assistance and inform stepped-care models. Objective: The primary objective was to compare the efficacy of a transdiagnostic biopsychosocial DMH program, with or without therapist assistance for adults with subthreshold symptoms or a diagnosis of anxiety or depression. Methods: In a randomized adaptive clinical trial design, all participants had access to the DMH program, with eligibility to have their program augmented with therapist assistance determined by program engagement or symptom severity. Participants who met stepped-care criteria were randomized to have their treatment program augmented with either low-intensity (10 min/week of video chat support for 7 weeks) or high-intensity (50 min/week of video chat support for 7 weeks) therapist assistance. A total of 103 participants (mean age 34.17, SD 10.50 years) were assessed before (week 0), during (weeks 3 and 6), and after the intervention (week 9) and at the 3-month follow-up (week 21). The effects of 3 treatment conditions (DMH program only, DMH program+low-intensity therapist assistance, and DMH program+high-intensity therapist assistance) on changes in the 2 primary outcomes of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were assessed using the Cohen d, reliable change index, and mixed-effects linear regression analyses. Results: There were no substantial differences in the outcome measures among intervention conditions. However, there were significant time effect changes in most outcomes over time. All 3 intervention conditions demonstrated strong and significant treatment effect changes in GAD-7 and PHQ-9 scores, with absolute Cohen d values ranging from 0.82 to 1.79 (all P<.05). The mixed-effects models revealed that, in the Life Flex program–only condition at week 3, mean GAD-7 and PHQ-9 scores significantly decreased from baseline by 3.54 and 4.38 (all P<.001), respectively. At weeks 6, 9, and 21, GAD-7 and PHQ-9 scores significantly decreased from baseline by at least 6 and 7 points (all P<.001), respectively. Nonresponders at week 3 who were stepped up to therapist assistance increased program engagement and treatment response. At the postintervention time point and 3-month follow-up, 67% (44/65) and 69% (34/49) of the participants, respectively, no longer met diagnostic criteria for anxiety or depression. Conclusions: The findings highlight that early detection of low engagement and non–treatment response presents an opportunity to effectively intervene by incorporating an adaptive design. Although the study findings indicate that therapist assistance was no more effective than the DMH intervention program alone for reducing symptoms of anxiety or depression, the data highlight the potential influence of participant selection bias and participant preferences within stepped-care treatment models. ©Brooke Andrews, Britt Klein, Huy Van Nguyen, Denise Corboy, Suzanne McLaren, Shaun Watson.
- Authors: Andrews, Brooke , Klein, Britt , Nguyen, Huy , Corboy, Denise , McLaren, Suzanne , Watson, Shaun
- Date: 2023
- Type: Text , Journal article
- Relation: Journal of Medical Internet Research Vol. 25, no. (2023), p.
- Full Text:
- Reviewed:
- Description: Background: Digital mental health (DMH) interventions incorporating elements that adapt to the evolving needs of consumers have the potential to further our understanding of the optimal intensity of therapist assistance and inform stepped-care models. Objective: The primary objective was to compare the efficacy of a transdiagnostic biopsychosocial DMH program, with or without therapist assistance for adults with subthreshold symptoms or a diagnosis of anxiety or depression. Methods: In a randomized adaptive clinical trial design, all participants had access to the DMH program, with eligibility to have their program augmented with therapist assistance determined by program engagement or symptom severity. Participants who met stepped-care criteria were randomized to have their treatment program augmented with either low-intensity (10 min/week of video chat support for 7 weeks) or high-intensity (50 min/week of video chat support for 7 weeks) therapist assistance. A total of 103 participants (mean age 34.17, SD 10.50 years) were assessed before (week 0), during (weeks 3 and 6), and after the intervention (week 9) and at the 3-month follow-up (week 21). The effects of 3 treatment conditions (DMH program only, DMH program+low-intensity therapist assistance, and DMH program+high-intensity therapist assistance) on changes in the 2 primary outcomes of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were assessed using the Cohen d, reliable change index, and mixed-effects linear regression analyses. Results: There were no substantial differences in the outcome measures among intervention conditions. However, there were significant time effect changes in most outcomes over time. All 3 intervention conditions demonstrated strong and significant treatment effect changes in GAD-7 and PHQ-9 scores, with absolute Cohen d values ranging from 0.82 to 1.79 (all P<.05). The mixed-effects models revealed that, in the Life Flex program–only condition at week 3, mean GAD-7 and PHQ-9 scores significantly decreased from baseline by 3.54 and 4.38 (all P<.001), respectively. At weeks 6, 9, and 21, GAD-7 and PHQ-9 scores significantly decreased from baseline by at least 6 and 7 points (all P<.001), respectively. Nonresponders at week 3 who were stepped up to therapist assistance increased program engagement and treatment response. At the postintervention time point and 3-month follow-up, 67% (44/65) and 69% (34/49) of the participants, respectively, no longer met diagnostic criteria for anxiety or depression. Conclusions: The findings highlight that early detection of low engagement and non–treatment response presents an opportunity to effectively intervene by incorporating an adaptive design. Although the study findings indicate that therapist assistance was no more effective than the DMH intervention program alone for reducing symptoms of anxiety or depression, the data highlight the potential influence of participant selection bias and participant preferences within stepped-care treatment models. ©Brooke Andrews, Britt Klein, Huy Van Nguyen, Denise Corboy, Suzanne McLaren, Shaun Watson.
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