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)
A mixed-methods 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.
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