Message-Based Psychotherapy and Digital Treatment Sequences for Depression

NCT ID: NCT04513080

Last Updated: 2025-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2024-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Study Adherence Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Arms/Interventions have been adjusted to align with the results for the Phase 2 SMART.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Message-Based Psychotherapy (MBP)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Video-Chat Psychotherapy (VCP)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy (MBP)

Intervention Type BEHAVIORAL

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 with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy (MBP)

Intervention Type BEHAVIORAL

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 with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

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.

Group Type EXPERIMENTAL

Video-Chat Psychotherapy (VCP)

Intervention Type BEHAVIORAL

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 with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

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.

Group Type EXPERIMENTAL

Video-Chat Psychotherapy (VCP)

Intervention Type BEHAVIORAL

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 with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

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.

Group Type EXPERIMENTAL

Video-Chat Psychotherapy (VCP)

Intervention Type BEHAVIORAL

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.

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy (MBP)

Intervention Type BEHAVIORAL

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.

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Video-Chat Psychotherapy (VCP)

Intervention Type BEHAVIORAL

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.

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy (MBP)

Intervention Type BEHAVIORAL

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.

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

High Monetary Incentive (HMI)

Intervention Type BEHAVIORAL

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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: 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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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: 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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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."

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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: 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.

Group Type EXPERIMENTAL

Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Intervention Type BEHAVIORAL

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".

Low Monetary and Alternative Incentive (LMAI)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video-Chat Psychotherapy (VCP)

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.

Intervention Type BEHAVIORAL

Message-Based Psychotherapy (MBP)

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.

Intervention Type BEHAVIORAL

Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

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".

Intervention Type BEHAVIORAL

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

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."

Intervention Type BEHAVIORAL

High Monetary Incentive (HMI)

Participants in the traditional, high monetary incentive arm will receive a total of $125 for completing 12 weeks of assessments.

Intervention Type BEHAVIORAL

Low Monetary and Alternative Incentive (LMAI)

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Washington

OTHER

Sponsor Role collaborator

Talkspace

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aarthi Padmanabhan

Senior Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Talkspace

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 41165707 (View on PubMed)

Arean 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.

Reference Type DERIVED
PMID: 34728440 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00010391

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Therapy and Tech Study
NCT07225192 NOT_YET_RECRUITING NA
Treating Suicidality Remotely
NCT06370104 RECRUITING NA