Back to results

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Primary Purpose

Study Adherence, Depressive Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Video-chat psychotherapy (VCP)

Message-based psychotherapy (MBP)

Message-based psychotherapy with monthly video chat (Premium Plan)

Message-based psychotherapy with weekly video chat (Ultimate Plan)

About this trial

This is an interventional treatment trial for Study Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TalkspaceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Phase 1, Level 1: Incentive 1 + Video-chat psychotherapy

Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP)

Phase 1, Level 2: MBP with weekly VCP

Phase 1 Level 2: MBP with monthly VCP

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

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

Phase 2, Level 2: MBP with monthly VCP

Phase 2, Level 2: MBP with weekly VCP

Phase 1, Level 1: Incentive 1 + Message-based psychotherapy

Phase 1, Level 1: Incentive 2 + Message-based psychotherapy

Arm Description

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.

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).

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).

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04513080

First Posted

August 9, 2020

Last Updated

August 10, 2023

Sponsor

Talkspace

Collaborators

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT04513080

Brief Title

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Official Title

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Talkspace

Collaborators

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Study Adherence, Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 1, Level 1: Incentive 1 + Video-chat psychotherapy

Arm Type

Experimental

Arm Description

Arm Title

Phase 1, Level 1: Incentive 2 + Video-chat psychotherapy (VCP)

Arm Type

Experimental

Arm Description

Arm Title

Phase 1, Level 2: MBP with weekly VCP

Arm Type

Experimental

Arm Description

Arm Title

Phase 1 Level 2: MBP with monthly VCP

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 2, Level 2: MBP with monthly VCP

Arm Type

Experimental

Arm Description

Arm Title

Phase 2, Level 2: MBP with weekly VCP

Arm Type

Experimental

Arm Description

Arm Title

Phase 1, Level 1: Incentive 1 + Message-based psychotherapy

Arm Type

Experimental

Arm Description

Arm Title

Phase 1, Level 1: Incentive 2 + Message-based psychotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Video-chat psychotherapy (VCP)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Message-based psychotherapy (MBP)

Intervention Description

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

Intervention Name(s)

Message-based psychotherapy with monthly video chat (Premium Plan)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Message-based psychotherapy with weekly video chat (Ultimate Plan)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Neuro-QoL - Ability to Participate in Social Roles and Activities

Description

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.

Time Frame

Change from Baseline Neuro-QoL at 6 weeks and 12 weeks after treatment starts

Title

Change in Patient Health Questionnaire (PHQ-9)

Description

Time Frame

Change from Baseline PHQ-9 at 6 weeks and 12 weeks after treatment starts

Secondary Outcome Measure Information:

Title

Change in Generalized Anxiety Disorder (GAD-7)

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Expectations about Treatment (TRS)

Description

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.

Time Frame

Baseline

Title

Experience of Care and Health Outcomes Survey (ECHO)

Description

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.

Time Frame

12 weeks after treatment starts

Title

Working Alliance Inventory (WAI)

Description

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.

Time Frame

12 weeks after treatment starts

Title

Tailoring Variable - Clinician-Administered PHQ-9

Description

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.

Time Frame

6 weeks after treatment starts

Title

Treatment Use Variables

Description

Phase 2: Number of sessions attended

Time Frame

12 weeks after treatment starts

Title

Treatment Use Variables

Description

Phase 2: Number of messages sent

Time Frame

12 weeks after treatment starts

Title

Treatment Use Variables

Description

Phase 2: Time between patient and psychotherapist contact

Time Frame

12 weeks after treatment starts

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brittany Mosser, MSW

Phone

206-616-2129

creativ@uw.edu

Facility Information:

Facility Name

Talkspace

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Derrick Hull, PhD

Phone

480-254-8815

derrick@talkspace.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.

Citations:

PubMed Identifier

34728440

Citation

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.

Results Reference

derived

Learn more about this trial

Message-Based Psychotherapy and Digital Treatment Sequences for Depression

We'll reach out to this number within 24 hrs