Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 13, 2022
Open Peer Review Period: Dec 13, 2022 - Feb 7, 2023
Date Accepted: Feb 28, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
An evaluation of various support intensities of digital mental health treatment for reducing anxiety and depression in adults: Study protocol for an adaptive randomised clinical trial
ABSTRACT
Background:
Digital mental health interventions increase accessibility to evidence-based psychological services delivered in a variety of online formats (e.g., self-help, therapist-assisted). Robust and rigorous research on adaptive online intervention designs is scarce. No identified randomised clinical trial has investigated the efficacy of a two-stage adaptive design, whereby the program only or ‘no support’ digital mental health treatment program is augmented by either low or high-therapist assistance, should a participant not improve or engage in the program only condition.
Objective:
The primary study objective is to test whether therapist-assisted support delivered via video-chat is more effective at reducing anxiety and depressive symptoms compared to a digital mental health program only condition.
Methods:
Australian adults (N = 137) with symptoms or a diagnosis of an anxiety and/or depression disorder will be screened for eligibility and given access to the 8-module Life Flex digital mental health treatment program. On day 15, participants who meet augmentation criteria will be ‘stepped up’ via block randomization to therapist video-chat for either 10 minutes (low-intensity) or 50 minutes (high-intensity) per week. This adaptive trial will implement a mixed-methods design.
Results:
The primary outcome measures are for anxiety (GAD-7) and depression severity (PHQ-9). Other measures will be used to assess secondary outcomes of working alliance, health status, health resources, self-efficacy, and motivation. Qualitative methods will be used to explore participant and therapist experiences of video-chat assessment and treatment with a focus on the therapeutic alliance. Outcomes will be assessed pre-, during, and post-intervention and at 3-month follow-up.
Conclusions:
This study protocol is the first mixed methods adaptive trial to explore the comparative efficacy of different levels of intensity of a therapist- assisted digital mental health program delivered via video-chat for Australian adults with anxiety and/or depression. The results are anticipated to have implementation implications for digital mental health interventions. Clinical Trial: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN: 12620000422921, Date Registered 30/03/2020.
Citation
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