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Completed

NCT Number: NCT04513080

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Talkspace

New York, 10025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video-Chat Psychotherapy (VCP)

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 (MBP)

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

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".

Message-Based Psychotherapy with Weekly Video-Chat Psychotherapy

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)

Behavioral

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

Low Monetary and Alternative Incentive (LMAI)

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.

Primary outcomes

  1. 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.

  2. 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

  1. Change in Generalized Anxiety Disorder (GAD-7)

    Time frame: Change from Baseline GAD-7 at 6 weeks and 12 weeks after treatment starts

    To assess for co-occurring anxiety, we will use the Generalized Anxiety Disorder-7 (GAD-7), a 7- item screener for generalized anxiety disorder (GAD). Participants rate on a scale of 0-3 how much they have experienced symptoms of GAD in the last two weeks. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety. The scale is a valid screener for GAD.

Other outcomes

  1. Expectations About Treatment: Treatment Rationale Scale (TRS)

    Time frame: Week 1

    Expectations about treatment can influence outcomes. To assess participant expectations, we will administer the Treatment Rationale Scale (TRS), a 4-item scale administered before the 2nd and last session. The scale assesses patient expectations about the success of treatment. Items are rated on a scale of 0 (not at all) to 10 (very). Total scores range from 0 to 40, with higher scores indicating better outcomes. 1) How logical does your Talkspace treatment seem to you? 2) How confident are you that the treatment will be successful in eliminating your depression? 3) How confident would you be in recommending the treatment to a friend with depression? 4) If you were extremely depressed, would you be willing to undergo such treatment?

  2. Experience of Care and Health Outcomes Survey (ECHO)

    Time frame: 10 weeks after treatment starts

    The Experience of Care and Health Outcomes Survey (ECHO) items assess whether consumers received timely treatment, enough information to support self-management, and were involved in treatment as much as they wanted. ECHO is a reliable instrument with alpha = .85. For quality of care, participants rated an adapted version of item 28 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) ECHO survey: "In the past 4 weeks, using any number from 0 to 10, where 0 is the worst mental health care possible and 10 is the best mental health care possible, what number would you use to rate the mental health care you received from Talkspace?" Ratings range from 0 to 10. Higher scores indicate better quality of care received.

  3. Working Alliance Inventory-Short Revised (WAI-SR)

    Time frame: 10 weeks after treatment starts

    Participants rated therapeutic alliance using the Working Alliance Inventory-Short Revised (WAI-SR), a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach) evaluating three domains: goals, tasks, and bond. Items are rated on a scale from 1 to 5. Total scores range from 12-60, with higher scores indicating a more effective therapeutic relationship. It is a reliable measure of alliance, with alpha = .92.

  4. Tailoring Variable - Response to Treatment

    Time frame: 6 weeks after treatment starts

    To determine whether patients move to Level 2 treatment (starting at week 6), we will used clinician administered Patient Health Questionnaire-9 (PHQ-9) between weeks 3 to 5 of treatment. Response to treatment was defined as a PHQ-9 score less than 50% of the participant's baseline PHQ-9 score. Response to treatment was also evaluated via therapist feedback. Participants who responded to their Level 1 treatment assignment continued in that condition from weeks 6 to 12. Participants who did not respond to treatment were switched to either MBP with weekly VCP or to MBP with monthly VCP.

  5. Treatment Use Variables: Number of Sessions Attended

    Time frame: 12 weeks after treatment starts

    Phase 1: Number of distinct days of messaging plus number of live video sessions attended Phase 2: Number of sessions attended, defined as the number of sessions during which the client sent any messages or attended any video sessions, regardless of Level 1 condition (e.g., includes sessions during which participants in VCP only sent messages).

  6. Treatment Use Variables: Number of Messages Sent

    Time frame: 12 weeks after treatment starts

    Number of messages sent, regardless of condition (e.g., also includes number of messages sent by clients in VCP only).

  7. Treatment Use Variables: Time Between Patient and Psychotherapist Contact

    Time frame: 12 weeks after treatment starts

    Time between patient and psychotherapist contact, defined as the number of days from client's Level 1 randomization date to the date of first psychotherapist message or video call. These data were available only for Phase 2.

Sponsors and collaborators

Lead sponsor

Talkspace

Industry

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2020
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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