Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Conditions
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Study Adherence, Depressive Disorder

Intervention / Treatment
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* Behavioral: Video-chat psychotherapy (VCP)
* Behavioral: Message-based psychotherapy (MBP)
* Behavioral: Message-based psychotherapy with monthly video chat (Premium Plan)
* Behavioral: Message-based psychotherapy with weekly video chat (Ultimate Plan)


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1, Level 1: Incentive 1 + Video-chat psychotherapy<br>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. | Behavioral: Video-chat psychotherapy (VCP)<br>* Video Chat Only (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.<br>|
| Experimental: Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP)<br>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. | Behavioral: Video-chat psychotherapy (VCP)<br>* Video Chat Only (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.<br>|
| Experimental: Phase 1, Level 2: MBP with weekly VCP<br>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). | Behavioral: Message-based psychotherapy with weekly video chat (Ultimate Plan)<br>* The Ultimate Plan 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.<br>|
| Experimental: Phase 1 Level 2: MBP with monthly VCP<br>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). | Behavioral: Message-based psychotherapy with monthly video chat (Premium Plan)<br>* The Premium plan 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.<br>|
| Experimental: Phase 2 Level 1: Message-Based Psychotherapy (MBP)<br>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. | Behavioral: Message-based psychotherapy (MBP)<br>* 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.<br>|
| Experimental: Phase 2, Level 1: Video-Chat Psychotherapy (VCP)<br>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. | Behavioral: Video-chat psychotherapy (VCP)<br>* Video Chat Only (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.<br>|
| Experimental: Phase 2, Level 2: MBP with monthly VCP<br>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. | Behavioral: Message-based psychotherapy with monthly video chat (Premium Plan)<br>* The Premium plan 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.<br>|
| Experimental: Phase 2, Level 2: MBP with weekly VCP<br>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. | Behavioral: Message-based psychotherapy with weekly video chat (Ultimate Plan)<br>* The Ultimate Plan 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.<br>|
| Experimental: Phase 1, Level 1: Incentive 1 + Message-based psychotherapy<br>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. | Behavioral: Message-based psychotherapy (MBP)<br>* 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.<br>|
| Experimental: Phase 1, Level 1: Incentive 2 + Message-based psychotherapy<br>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. | Behavioral: Message-based psychotherapy (MBP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neuro-QoL - Ability to Participate in Social Roles and Activities | 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. | Change from Baseline Neuro-QoL at 6 weeks and 12 weeks after treatment starts | 
| Change in Patient Health Questionnaire (PHQ-9) | 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 from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Generalized Anxiety Disorder (GAD-7) | 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. | Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts |