Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 17, 2022
Date Accepted: Apr 3, 2023
An exploration of the preliminary effectiveness and acceptability of a fully-automated self-help biopsychosocial transdiagnostic digital intervention to reduce anxiety and/or depression and improve emotional regulation and wellbeing in adults: A pre, during, post and follow-up, single-arm, feasibility trial design.
ABSTRACT
Background:
Anxiety disorders and depression are prevalent disorders with high comorbidity, leading to greater chronicity and severity of symptoms. Given accessibility to treatment issues, more evaluation is needed assessing the potential benefit of fully-automated self-help transdiagnostic (TD) digital interventions. Innovating beyond the current TD ‘one-size-fits-all’ shared mechanistic approach may also lead to greater improvements.
Objective:
The primary objective of this study was to explore the preliminary effectiveness and acceptability of a new fully-automated self-help biopsychosocial TD digital intervention (Life Flex) aiming to treat anxiety and/or depression, as well as improve emotional regulation, emotional, social and psychological wellbeing, 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 pre-intervention (Week 0), during-intervention (Weeks 3 and 5), post-intervention (Week 8), and at a 1- and 3-month follow-up (Week 12 and 20 respectively).
Results:
: The results provided early support for the Life Flex program in reducing anxiety (GAD-7), depression (PHQ-9), psychological distress (K-6), and emotional dysregulation (DERS-36), and increasing emotional, social and psychological wellbeing (MHC-SF), optimism (R-LOT) and health-related quality of life (EQ-5D Utility Index and Health Rating) (all p<.001). Large within-group treatment effect sizes (range d=-0.83 to 1.30) were found on most variables from pre- to post-intervention and at the 1- and 3-month follow-up. The exceptions were medium treatment effect sizes for EQ-5D Utility Index (range d=-0.50 to -0.63) and optimism (range d=-0.72 to -0.90) and medium-to-small treatment effect size change for EQ-5D Health Rating (range d=-0.34 to -0.63). Changes across all outcome variables were generally strongest for participants with pre-intervention clinical comorbid anxiety and depression presentations (range d=-0.58 to 2.01) and weakest for participants presenting with non-clinical subthreshold anxiety and/or depressive symptoms (d=-0.05 to 0.84). Life Flex was rated as acceptable at post-intervention and participants indicated that they enjoyed the TD program and biological, wellness and lifestyle focused content and strategies.
Conclusions:
Given the paucity of evidence on fully-automated self-help TD digital interventions for anxiety and/or depressive symptomatology, and general treatment accessibility issues, this study provides preliminary support for biopsychosocial TD interventions like Life Flex being a promising future mental health service delivery gap filler. Following large-scale, randomized controlled trialling, the potential benefits of fully-automated self-help digital health programs like Life Flex could be considerable. Clinical Trial: ACTRN12615000480583
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