Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Talkspace

Status: Completed

Conditions: Study Adherence; Depressive Disorder

Treatments: Behavioral: Message-Based Psychotherapy (MBP); Behavioral: Low Monetary and Alternative Incentive (LMAI); Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy; Behavioral: High Monetary Incentive (HMI); Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy; Behavioral: Video-Chat Psychotherapy (VCP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04513080

STUDY00010391

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and exclusion criteria are the same for Phase 1 and Phase 2.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

1,184 participants in 18 patient groups

Phase 2: Message-Based Psychotherapy (MBP; Level 1 and Level 2)

Experimental group

Description:

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).

Treatment:

Behavioral: Message-Based Psychotherapy (MBP)

Phase 2: Video-Chat Psychotherapy (VCP; Level 1 and Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Video-Chat Psychotherapy (VCP)

Phase 2: MBP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Behavioral: Message-Based Psychotherapy (MBP)

Phase 2: MBP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Behavioral: Message-Based Psychotherapy (MBP)

Phase 2: VCP (Level 1) to Premium Plan (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Video-Chat Psychotherapy (VCP)

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Phase 2: VCP (Level 1) to Ultimate Plan (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Video-Chat Psychotherapy (VCP)

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Phase 1: High Monetary Incentive (HMI) + VCP (Level 1 and Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Video-Chat Psychotherapy (VCP)

Behavioral: High Monetary Incentive (HMI)

Phase 1: High Monetary Incentive (HMI) + MBP (Level 1 and Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: High Monetary Incentive (HMI)

Behavioral: Message-Based Psychotherapy (MBP)

Phase 1: Low Monetary and Alternative Incentive (LMAI) + VCP (Level 1 and Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Video-Chat Psychotherapy (VCP)

Behavioral: Low Monetary and Alternative Incentive (LMAI)

Phase 1: Low Monetary and Alternative Incentive (LMAI) + MBP (Level 1 and Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Low Monetary and Alternative Incentive (LMAI)

Behavioral: Message-Based Psychotherapy (MBP)

Phase 1: HMI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Behavioral: High Monetary Incentive (HMI)

Phase 1: HMI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: High Monetary Incentive (HMI)

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Phase 1: HMI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Behavioral: High Monetary Incentive (HMI)

Phase 1: HMI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: High Monetary Incentive (HMI)

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Phase 1: LMAI + VCP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Behavioral: Low Monetary and Alternative Incentive (LMAI)

Phase 1: LMAI + VCP (Level 1) to Switch Arm (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Behavioral: Low Monetary and Alternative Incentive (LMAI)

Phase 1: LMAI + MBP (Level 1) to Augmentation Arm (MBP with weekly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

Behavioral: Low Monetary and Alternative Incentive (LMAI)

Phase 1: LMAI + MBP (Level 1) to Minimal Augmentation (MBP with monthly VCP; Level 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Message-Based Psychotherapy with Monthly Video-Chat Psychotherapy

Behavioral: Low Monetary and Alternative Incentive (LMAI)