Message-Based Psychotherapy and Digital Treatment Sequences for Depression
1 other identifier
interventional
1,184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2020
CompletedFirst Submitted
Initial submission to the registry
August 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2024
CompletedResults Posted
Study results publicly available
October 30, 2025
CompletedOctober 30, 2025
October 1, 2025
3.9 years
August 9, 2020
May 7, 2025
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Neuro-QOL - Ability to Participate in Social Roles and Activities
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 from Baseline Neuro-QOL at 6 weeks and 12 weeks after treatment starts
Change in Patient Health Questionnaire (PHQ-9)
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 from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts
Secondary Outcomes (1)
Change in Generalized Anxiety Disorder (GAD-7)
Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts
Other Outcomes (7)
Expectations About Treatment: Treatment Rationale Scale (TRS)
Week 1
Experience of Care and Health Outcomes Survey (ECHO)
10 weeks after treatment starts
Working Alliance Inventory-Short Revised (WAI-SR)
10 weeks after treatment starts
- +4 more other outcomes
Study Arms (18)
Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2)
EXPERIMENTALPhase 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).
Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2)
EXPERIMENTALPhase 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.
Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)
EXPERIMENTALPhase 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.
Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)
EXPERIMENTALPhase 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.
Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)
EXPERIMENTALPhase 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.
Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)
EXPERIMENTALPhase 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.
Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)
EXPERIMENTALPhase 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.
Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)
EXPERIMENTALPhase 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.
Interventions
Video-Chat Psychotherapy (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety.
Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies.
Message-Based Psychotherapy (MBP) with monthly Video-Chat Psychotherapy (VCP) allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. Therapist and participants schedule their video chat appointment to occur at once a month interval during therapist office hours. The content of these sessions, as well as the MBP portion of care, will be based on CBT, PST or IPT. In Phase 1, this is referred to as "Switch Arm" (for participants assigned to VCP at baseline) or "Minimal Augmentation" (for participants assigned to MBP at baseline). In Phase 2, this is referred to as the "Premium Plan".
Message-Based Psychotherapy (MBP) with weekly Video-Chat Psychotherapy (VCP) allows patients access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. Therapists will provide care based on CBT, PST or IPT. In Phase 1, this is referred to as the "Augmentation Arm". In Phase 2, this is referred to as the "Ultimate Plan."
Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.
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.
Eligibility Criteria
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talkspacelead
- University of Washingtoncollaborator
Study Sites (1)
Talkspace
New York, New York, 10025, United States
Related Publications (2)
Pullmann MD, Rouvere J, Raue PJ, Griffith Fillipo IR, Mosser BA, Heagerty PJ, Fridling-Cook N, Padmanabhan A, Hull TD, Arean PA. Message-Based vs Video-Based Psychotherapy for Depression: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2540065. doi: 10.1001/jamanetworkopen.2025.40065.
PMID: 41165707DERIVEDArean P, Hull D, Pullmann MD, Heagerty PJ. Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based psychotherapy for depression compared with telepsychotherapy. BMJ Open. 2021 Nov 2;11(11):e046958. doi: 10.1136/bmjopen-2020-046958.
PMID: 34728440DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aarthi Padmanabhan
- Organization
- Talkspace
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Director of Research
Study Record Dates
First Submitted
August 9, 2020
First Posted
August 14, 2020
Study Start
March 2, 2020
Primary Completion
January 14, 2024
Study Completion
January 14, 2024
Last Updated
October 30, 2025
Results First Posted
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.