Message-Based Psychotherapy and Digital Treatment Sequences for Depression
- Conditions
- Study AdherenceDepressive Disorder
- Interventions
- Behavioral: Video-chat psychotherapy (VCP)Behavioral: Message-based psychotherapy (MBP)Behavioral: Message-based psychotherapy with weekly video chat (Ultimate Plan)Behavioral: Message-based psychotherapy with monthly video chat (Premium Plan)
- Registration Number
- NCT04513080
- Lead Sponsor
- Talkspace
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 973
- 18 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1, Level 1: Incentive 1 + Video-chat psychotherapy Video-chat psychotherapy (VCP) In Phase 1, participants will be randomized to one of two incentive levels. After randomization to an incentive level, participants will be randomized to either video-chat psychotherapy (VCP) or message-based psychotherapy (MBP). After six weeks of treatment, participants will move to level 2. Those who have made a 50% reduction to PHQ9 scores to their assigned treatment will continue in that same treatment for 6 more weeks. Phase 2 Level 1: Message-Based Psychotherapy (MBP) Message-based psychotherapy (MBP) Phase 2 participants who respond to MBP after 6 weeks of care will continue in this condition for another 6 weeks. Participants who do not respond by week 6 will be randomized to one of two augmentation arms, MBP plus monthly video chat (Premium Plan: PP) or MBP plus weekly video chat (Ultimate Plan: UP) for another 6 weeks of care. Phase 2, Level 1: Video-Chat Psychotherapy (VCP) Video-chat psychotherapy (VCP) Phase 2: Weekly psychotherapy appointments that last between 30-45 minutes. Participants who do not respond to this model will be randomized to switch (PP) or augment (UP) VCP. Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP) Video-chat psychotherapy (VCP) In Phase 1, participants will be randomized to one of two incentive levels. After randomization to an incentive level, participants will be randomized to either video-chat psychotherapy (VCP) or message-based psychotherapy (MBP). After six weeks of treatment, participants will move to level 2. Those who have made a 50% reduction to PHQ9 scores to their assigned treatment will continue in that same treatment for 6 more weeks. Phase 1, Level 2: MBP with weekly VCP Message-based psychotherapy with weekly video chat (Ultimate Plan) Phase 1 participants who do not show 50% reduction in PHQ9 scores will be randomized to either weekly VCP augmented with unlimited MBP (augmentation arm), monthly VCP with unlimited MBP (switch/minimal augmentation arm). Phase 1, Level 1: Incentive 1 + Message-based psychotherapy Message-based psychotherapy (MBP) In Phase 1, participants will be randomized to one of two incentive levels. After randomization to an incentive level, participants will be randomized to either video-chat psychotherapy (VCP) or message-based psychotherapy (MBP). After six weeks of treatment, participants will move to level 2. Those who have made a 50% reduction to PHQ9 scores to their assigned treatment will continue in that same treatment for 6 more weeks. Phase 1 Level 2: MBP with monthly VCP Message-based psychotherapy with monthly video chat (Premium Plan) Phase 1 participants randomized to VCP who do not show 50% reduction in PHQ9 scores will be randomized to either weekly VCP augmented with unlimited MBP (augmentation arm) or monthly VCP with unlimited MBP (switch/minimal augmentation arm). Phase 2, Level 2: MBP with monthly VCP Message-based psychotherapy with monthly video chat (Premium Plan) Phase 2: This intervention will serve as the "switch arm" for participants who do not respond to VCP by week 6, and one of two augmentation arms for participants who do not respond to MBP. The Premium plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. Phase 2, Level 2: MBP with weekly VCP Message-based psychotherapy with weekly video chat (Ultimate Plan) Phase 2: This intervention will serve as an augmentation arm for participants who do not respond to either MBP or VCP after 6 weeks of care. Like the Premium Plan, participants will have access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. Phase 1, Level 1: Incentive 2 + Message-based psychotherapy Message-based psychotherapy (MBP) In Phase 1, participants will be randomized to one of two incentive levels. After randomization to an incentive level, participants will be randomized to either video-chat psychotherapy (VCP) or message-based psychotherapy (MBP). After six weeks of treatment, participants will move to level 2. Those who have made a 50% reduction to PHQ9 scores to their assigned treatment will continue in that same treatment for 6 more weeks.
- Primary Outcome Measures
Name Time Method Change in Patient Health Questionnaire (PHQ-9) Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts Phase 2: The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time.
Change in Neuro-QoL - Ability to Participate in Social Roles and Activities Change from Baseline Neuro-QoL at 6 weeks and 12 weeks after treatment starts Phase 2: The Neuro-QoL is used to assess ability to participate in social roles and activities and will be used to assess functioning and disability.
- Secondary Outcome Measures
Name Time Method Change in Generalized Anxiety Disorder (GAD-7) Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts Phase 2: To assess for co-occurring anxiety, we will use the GAD-7, a 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.
Trial Locations
- Locations (1)
Talkspace
🇺🇸New York, New York, United States