Message-Based Psychotherapy and Digital Treatment Sequences for Depression

  • STATUS
    Recruiting
  • End date
    Jun 22, 2024
  • participants needed
    1000
  • sponsor
    Talkspace
Updated on 22 April 2022
depression
anxiety
depressed mood

Summary

This partnership between Talkspace and the UW ALACRITY Center will determine how effective unlimited text-based psychotherapy for depression is when compared to once-a-week psychotherapy. This study will also determine what the best treatment options are for people who are not responding well to either unlimited texting or weekly psychotherapy. The results of this study will be a new product version of message-based care that can tailor psychotherapy intensity based on the needs of future consumers with depression.

Description

This is a fast track SBIR proposal that will (1) test the effectiveness of daily, message-based psychotherapy (MBP) for depression, compared to traditionally delivered, video-chat psychotherapy (VCP) and (2) develop an evidence-based treatment sequence for those who do not respond to either daily MBP or VCP.

Phase 1 consists of a pilot study to determine the best incentive model to retain a sample of people 18 years old and older with depression into a SMART trial. Information from this pilot will inform the retention strategy for Phase 2.

Phase 2 is a 12-week, randomized clinical trial using a SMART design to test the following aims: 1. Determine the relative effectiveness of daily MBP compared to weekly VCP in treating symptoms of depression and improving social functioning; 2. For those who fail to respond to 6 weeks of weekly VCP only, determine whether the addition of daily messaging, or a switch to monthly video-chat plus daily messaging improves depression and functional outcomes; and 3. For those who fail to respond to 6 weeks of daily MBP, whether the addition of monthly video-chat or weekly video-chat improves outcomes. Participants will provide data on mood, activity, and functioning, and we will collect data on use of treatment (texts and sessions), and working alliance.

Details
Condition Study Adherence, Depressive Disorder
Treatment Video-chat psychotherapy (VCP), Message-based psychotherapy (MBP), Message-based psychotherapy with monthly video chat (Premium Plan), Message-based psychotherapy with weekly video chat (Ultimate Plan)
Clinical Study IdentifierNCT04513080
SponsorTalkspace
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years old or older
English or Spanish speaking
Live in the United States
Score of 10 or greater on the PHQ-9 screening
Receive a diagnosis of depression from a Talkspace intake clinician

Exclusion Criteria

Under the age of 18
Non-English or Spanish speaking
Do not meet criteria for a depressive disorder
Participants with active suicidal ideation or with a primary diagnosis of psychosis will also be excluded and referred to intensive care
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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