Message-Based Psychotherapy and Digital Treatment Sequences for Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Talkspace
- Enrollment
- 1,184
- Locations
- 1
- Primary Endpoint
- Change in Patient Health Questionnaire (PHQ-9)
Study Overview
Brief Summary
This partnership between Talkspace and the University of Washington (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 Small Business Innovation Research (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion and
Exclusion Criteria
- •are the same for Phase 1 and Phase
- •Inclusion Criteria:
- •18 years old or older
- •English or Spanish speaking
- •Live in the United States
- •Score of 10 or greater on the Patient Health Questionnaire-9 (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.
Arms & Interventions
Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2)
Phase 2 participants who respond to Message-Based Psychotherapy (MBP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2).
Intervention: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2)
Phase 2 participants who respond to Video-Chat Psychotherapy (VCP; Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). VCP consists of weekly psychotherapy appointments that last between 30-45 minutes.
Intervention: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in MBP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Premium Plan intervention consists of MBP with monthly VCP (Level 2). The Premium Plan allows patients unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
Phase 2: This arm includes participants in VCP (Level 1) who do not respond to treatment by week 5. The Ultimate Plan intervention consists of MBP with weekly VCP (Level 2). The Ultimate Plan allows patients unlimited MBP and weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two Level 2 conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
Intervention: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
Intervention: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the High Monetary Incentive (HMI) arm received a total of $125 for completing 12 weeks of assessments.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate.
Intervention: Video-Chat Psychotherapy (VCP) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)
Phase 1 participants who respond to VCP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (VCP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate.
Intervention: Message-Based Psychotherapy (MBP) (Behavioral)
Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)
Phase 1 participants who respond to MBP (Level 1) by 5 weeks of care will continue in this condition from weeks 6 to 12 (MBP; Level 2). Participants in the Low Monetary and Alternative Incentive (LMAI) arm received a total of $75 for completing 12 weeks of assessments, messages of encouragement for completing daily assessments, and weekly texts showing participants their clinical improvement and assessment completion rate.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in HMI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: High Monetary Incentive (HMI) (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + VCP (Level 1) who do not respond to treatment by week 5. The Switch Arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Augmentation Arm consists of MBP with weekly VCP (Level 2). Participants will have access to unlimited MBP and will be able to schedule weekly, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy (Behavioral)
Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
Phase 1: This arm includes participants in LMAI + MBP (Level 1) who do not respond to treatment by week 5. The Minimal Augmentation arm consists of MBP with monthly VCP (Level 2). Patients have access to unlimited MBP and once a month, 30-45 minute video chat with the same therapist. This intervention will serve as one of two conditions for participants who do not respond to MBP or VCP alone by week 5.
Intervention: Low Monetary and Alternative Incentive (LMAI) (Behavioral)
Outcomes
Primary Outcomes
Change in Patient Health Questionnaire (PHQ-9)
Time Frame: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (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. Total scores range from 0-27, with higher scores indicating greater severity of depression.
Change in Neuro-QOL - Ability to Participate in Social Roles and Activities
Time Frame: Change from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts
Neuro-Quality of Life v1.0 (Neuro-QOL). The Neuro-QOL Ability to Participate in Social Roles and Activities short form item bank is an 8-item patient-rated measure of social functioning. Items focus on difficulty participating in social, family, and work activities, and are rated on a 1 to 5 scale for a total score between 8 and 40. Neuro-QOL scores were transformed into t-scores per the scoring manual; after transformation, total scores range from 24.1 to 60.2. Transformed scores are reported. Higher scores indicate less difficulty participating in social roles and activities. The Neuro-QOL was not distributed in Phase 1.
Change in Patient Health Questionnaire (PHQ-9)
Time Frame: Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items and one disability item. Each time is associated with a Diagnostic and Statistical Manual (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. Total scores range from 0-27, with higher scores indicating greater severity of depression.
Secondary Outcomes
- Change in Generalized Anxiety Disorder (GAD-7)(Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts)
- Change in Generalized Anxiety Disorder (GAD-7)(Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts)
Investigators
Aarthi Padmanabhan
Senior Director of Research
Talkspace