Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depressive Disorder
  • Study Adherence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Phase 1 will test the effectiveness of two forms of participant retention methods into a SMART (sequential, multiple assignment, randomized). In Phase 1, participants (n=200) will be randomized to an incentive level and then randomized to treatment arms. Phase 2 (n=1000) will be the subsequent SMART design comparing message-based psychotherapy (MBP) to video-chat psychotherapy (VCP) in level 1 and for those who do not respond to care after 6 weeks, those participants will be randomized to either MBP+monthly VCP or MBP+weekly VCP.Masking: Single (Outcomes Assessor)Masking Description: In Phase 1, participants will be masked to the incentive condition to which they are randomized but will be aware of which treatment condition they are receiving.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 MB...

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.

Tracking Information

NCT #
NCT04513080
Collaborators
University of Washington
Investigators
Not Provided