Evaluation of Various Support Intensities of Digital Mental Health Treatment for Reducing Anxiety and Depression in Adults: Protocol for a Mixed Methods, Adaptive, Randomized Clinical Trial

JMIR Research Protocols · 5 authors, 4 centres

AI SUMMARY

FIDELITY 100%

POPULATIONAustralian adults with symptoms or a diagnosis of anxiety or depression (target N=137; 113 eligible enrolled)

INTERVENTION8-module Life Flex dMH treatment program with optional stepped-up therapist assistance via video chat (low intensity: 10 min/week or high intensity: 50 min/week)

COMPARISONdMH program-only (no therapist assistance)

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AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This protocol paper describes the design of an adaptive mixed methods randomized clinical trial comparing three support intensities for a digital mental health (dMH) intervention.

Full summary

550 CHARS

This protocol paper describes the design of an adaptive mixed methods randomized clinical trial comparing three support intensities for a digital mental health (dMH) intervention. Primary outcomes are GAD-7 (anxiety) and PHQ-9 (depression) measured at baseline, weeks 3, 6, 9, and 21. Qualitative thematic analysis will explore participant and therapist experiences. This is a protocol; trial results are forthcoming and therefore no efficacy conclusions can be drawn. Known limitations include anticipated high attrition common in dMH interventions.

PICO

PPOPULATION

Australian adults with symptoms or a diagnosis of anxiety or depression (target N=137; 113 eligible enrolled)

IINTERVENTION

8-module Life Flex dMH treatment program with optional stepped-up therapist assistance via video chat (low intensity: 10 min/week or high intensity: 50 min/week)

OOUTCOME

Anxiety severity (GAD-7) and depression severity (PHQ-9) at weeks 0, 3, 6, 9, and 21

STUDY TYPE

RCT

SPECIALTY

psychiatry

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10182448

Evaluation of Various Support Intensities of Digital Mental Health Treatment for Reducing Anxiety and Depression in Adults: Protocol for a Mixed Methods, Adaptive, Randomized Clinical Trial

JMIR Research Protocols

READ THE FULL PAPER

ABSTRACT

Abstract Background Anxiety and depression are leading causes of disease worldwide, requiring timely access to evidence-based treatment. Digital mental health (dMH) interventions increase accessibility to evidence-based psychological services delivered in a variety of web-based formats (eg, self-help and therapist-assisted interventions). Robust and rigorous studies of adaptive web-based intervention designs are scarce. No identified randomized clinical trial has investigated the efficacy of a 2-stage adaptive design, whereby the program-only condition or no support dMH treatment program is augmented by either low or high therapist assistance, if a participant does not improve or engage in the program-only condition. Objective The primary objective is to assess whether low or high therapist-assisted support delivered via video chat is more effective in reducing anxiety and depressive symptoms compared with a dMH program–only condition. The secondary objective is to evaluate the role of motivation; self-efficacy; and preferences in participant engagement, adherence, and clinical outcomes (anxiety and depression symptoms) among the 3 treatment conditions (program only, low-intensity therapist assistance, and high-intensity therapist assistance). A mixed methods analysis of factors affecting participant attrition, participant reasons for nonengagement and withdrawal, and therapist training and implementation of dMH interventions will be completed. Qualitative data regarding participant and therapist experiences and satisfaction with video chat assessment and treatment will also be analyzed. Methods Australian adults (N=137) with symptoms or a diagnosis of anxiety or depression will be screened for eligibility and given access to the 8-module Life Flex dMH treatment program. On day 15, participants who meet the augmentation criteria will be stepped up via block randomization to receive therapist assistance delivered via video chat for either 10 minutes (low intensity) or 50 minutes (high intensity) per week. This adaptive trial will implement a mixed methods design, with outcomes assessed before the intervention (week 0), during the intervention (weeks 3 and 6), after the intervention (week 9), and at the 3-month follow-up (week 21). Results The primary outcome measures are for anxiety (Generalized Anxiety Disorder–7) and depression severity (Patient Health Questionnaire–9). Measures of working alliance, health status, health resources, preferences, self-efficacy, and motivation will be used for secondary outcomes. Qualitative methods will be used to explore participant and therapist experiences of video chat assessment and treatment, participant reasons for withdrawal and nonengagement, and therapist training and implementation experiences. Data collection commenced in November 2020 and was completed at the end of March 2022. Conclusions This is the first mixed methods adaptive trial to explore the comparative efficacy of different intensity levels of self-help and a therapist-assisted dMH intervention program delivered via video chat for adults with anxiety or depression. Anticipated results may have implications for the implementation of dMH interventions. Trial Registration Australian and New Zealand Clinical Trials Registry 12620000422921; https://tinyurl.com/t9cyu372 International Registered Report Identifier (IRRID) RR1-10.2196/45040 Keywords: video chat therapy, therapist assistance, self-help, transdiagnostic, digital intervention, anxiety, depression, comorbidity

CITATION EXPORT

Brooke Andrews, Britt Klein, Suzanne McLaren et al.. Evaluation of Various Support Intensities of Digital Mental Health Treatment for Reducing Anxiety and Depression in Adults: Protocol for a Mixed Methods, Adaptive, Randomized Clinical Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/45040

AUTHORS

5 · 4 CENTRES

Brooke Andrews, Britt Klein, Suzanne McLaren, Shaun Watson, Denise Corboy

1Health Innovation & Transformation Centre, Federation University Australia, Ballarat, Australia
2Biopsychosocial & eHealth Research & Innovation, Federation University Australia, Ballarat, Australia
3Charles Sturt University, Port Macquarie, Australia
4Blue Sky Mind Research Consultancy, Ballarat, Australia