Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based...

Area of Science:

• Mental Health
• Psychotherapy Research
• Digital Health Interventions

Background:

• Digital mental health tools are increasingly used as alternatives to traditional psychotherapy.
• Message-based care, utilizing text or asynchronous messaging, is an emerging digital mental health modality.
• The efficacy of message-based care, as a standalone or adjunctive treatment, remains under-researched.

Purpose of the Study:

• To compare the effectiveness of message-based care, videoconference psychotherapy, and a combination of both.
• To evaluate these digital mental health interventions in 1000 adults with depression.
• To explore moderators of treatment outcomes in digital mental health care.

Main Methods:

• A sequential, multiple assignment randomized trial involving 1000 depressed adults.
• Participants were recruited via Talkspace and randomized to 6 weeks of message-based care or videoconference psychotherapy.
• Non-responders were re-randomized to different intensities of videoconference psychotherapy and message-based care.

Main Results:

• Primary outcomes include depression severity and social functioning.
• Treatment response was defined as a 50% or greater reduction in depression symptoms.
• The trial is registered as NCT04513080 and is currently in the pre-results phase.

Conclusions:

• This study will provide crucial data on the effectiveness of digital mental health treatments.
• Findings will inform the integration of message-based care and videoconference psychotherapy in clinical practice.
• Results will be disseminated through peer-reviewed publications and professional conferences.