JMIR Publications

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 the study was to test the preliminary effectiveness of a new fully-automated self-help biopsychosocial TD digital intervention (Life Flex) which aims 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 quasi-experimental trial design evaluation of Life Flex. Participants (N=241) were assessed at pre-intervention (Week 0), post-intervention (Week 8), and at a 1- and 3-month follow-up (Week 12 and 20 respectively).

Results:

The results provided preliminary support for the Life Flex program as being effective in significantly 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, except for the EQ-5D Health Rating of P=.03). 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 (range d=-0.62 to -0.77) for EQ-5D Utility Index and medium to small treatment effect size change for EQ-5D Health Rating (range d=-0.37 to -0.60). Changes on all the outcome variables were strongest for those with pre-intervention clinical comorbid anxiety and depression presentations (range d=0.60 to 2.39) and least for those presenting with non-clinical subthreshold anxiety and/or depressive symptoms (d=0.01 to -0.67). Logistic regression found that lower environmental mastery (OR=1.97, P=.002, 95% CI=1.16 – 1.97) and social integration (OR=1.39, P=.015, 95% CI=1.07 – 1.81) MHC-SF item scores, reported difficulties in falling asleep (OR = 0.46, P=.039, 95% CI=0.22 – 0.96) and lower pre-intervention treatment expectancy and credibility/acceptability ratings (OR=1.36, P=.023, 95% CI=1.04 – 1.77), significantly predicted program non-adherence. The Life Flex program was rated as acceptable at post-intervention and participants indicated that they enjoyed the TD program and additions, which included biological, wellness and life-style 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 evidence for biopsychosocial TD interventions like Life Flex being able to fill the mental health service delivery gap. However further research is required, especially testing Life Flex against comparator conditions, dismantling ‘content’ studies, and the potential collection of biomarker measurements alongside psychologically-based metrics. Clinical Trial: ACTRN12615000480583