Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Depressive Disorder Clinical Trial

Official title:

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04513080
• Other study ID #: STUDY00010391
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Talkspace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 973
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Study Adherence

Intervention

Behavioral:
• Video-chat psychotherapy (VCP)
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.
• 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.
• Message-based psychotherapy with monthly video chat (Premium Plan)
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.
• Message-based psychotherapy with weekly video chat (Ultimate Plan)
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.

Locations

Country	Name	City	State
United States	Talkspace	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Talkspace	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectations about Treatment (TRS)	Phase 2: 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.	Baseline
Other	Experience of Care and Health Outcomes Survey (ECHO)	Phase 2: 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.	12 weeks after treatment starts
Other	Working Alliance Inventory (WAI)	Phase 2: The WAI is a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach). It is a reliable measure of alliance, with alpha = .92.	12 weeks after treatment starts
Other	Tailoring Variable - Clinician-Administered PHQ-9	Phase 2: To determine whether patients move to level II treatment we will used clinician administered PHQ9 at week 6 of treatment. Anyone falling below a 50% change in baseline PHQ9 scores will be switch to either the Platinum Plan (PP) condition or Ultimate Plan (UP) condition.	6 weeks after treatment starts
Other	Treatment Use Variables	Phase 2: Number of sessions attended	12 weeks after treatment starts
Other	Treatment Use Variables	Phase 2: Number of messages sent	12 weeks after treatment starts
Other	Treatment Use Variables	Phase 2: Time between patient and psychotherapist contact	12 weeks after treatment starts
Primary	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
Primary	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	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