JMIR Publications

ABSTRACT

Background:

Digital mental health interventions that incorporate adaptive elements have the potential to further our understanding of optimal intensity of therapist-assistance and inform stepped care models. Further evaluation is needed to assess various support intensities of digital mental health intervention programs that adapt to the evolving needs of consumers.

Objective:

The primary objective was to investigate and comparatively evaluate the efficacy of a transdiagnostic biopsychosocial digital mental health intervention program called Life Flex with or without therapist-assistance for adults with sub-threshold symptoms or a diagnosis of anxiety and/or depression.

Methods:

The study is a randomised adaptive clinical trial design. At step 1, all participants had access to the Life Flex program with eligibility to have their program augmented with therapist-assistance determined by program engagement and/or symptom severity. At step 2, participants who met stepped-care criteria were randomised to have their treatment program augmented with either low-intensity therapist-assistance (10 minutes per week of video-chat support for 7 weeks) or high-intensity therapist-assistance (50 minutes per week of video-chat support for 7 weeks). Participants (N = 103, Age M = 34.17, SD = 10.50) were assessed at pre-intervention (Week 0), during intervention (Week 3, Week 6), post-intervention (Week 9), and at 3-month follow-up (Week 21). Participants also completed diagnostic assessments at pre-intervention, post-intervention and 3-month follow-up. The primary outcomes of anxiety (GAD-7) and depression (PHQ-9) were tested in three conditions: Life Flex program only, Life Flex program + low-intensity therapist-assistance, and Life Flex program + high-intensity therapist-assistance.

Results:

There were no significant differences in the outcome measures between intervention conditions. However, there were significant time effect changes in most outcomes over timepoints. All three intervention conditions demonstrated strong and significant treatment effect change on the two primary outcomes (GAD-7 and PHQ-9) and one secondary outcome (mental health rating), with absolute values of Cohen’s d ranging from 0.82 to 1.79. Results showed that non-responders at week 3 who were stepped-up to therapist-assistance were able to increase program engagement and treatment response in step 2. At post-intervention, 67.7% of participants no longer met diagnostic criteria for anxiety and/or depression and at 3-month follow-up, 69.4% no longer met any diagnostic criteria.

Conclusions:

The findings highlight that early detection of engagement and non-treatment response presents an opportunity to increase consumer engagement within digital mental health intervention studies incorporating an adaptive design. While study findings indicate that therapist-assistance was no more effective than digital mental health intervention program only for reducing symptoms of anxiety and/or depression, the data highlight the potential influence of participant selection bias and participant preferences within stepped-care treatment models. The study provides evidence of the efficacy of a transdiagnostic biopsychosocial digital mental health intervention program however further research is required. Clinical Trial: ACTRN12620000422921