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Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Message-based psychotherapy (MBP)
Video-chat Psychotherapy (VCP)
Sponsored by
Talkspace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

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

Inclusion Criteria:

  • English speaking
  • 19 years old or older
  • PHQ-9 or GAD-7 score of at least 10 and no more than 20
  • Must have a valid email address
  • Must be willing to receive assessment survey links via email

Exclusion Criteria:

  • Non-English speaking
  • Under the age of 19
  • PHQ-9 or GAD-7 score below 10 or above 20
  • Inability to receive emails
  • Inability or unwilling to receive assessment survey links via email

Sites / Locations

  • Talkspace

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Message-based psychotherapy (MBP)

Video-chat psychotherapy (VCP)

Arm Description

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a 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 in Generalized Anxiety Disorder (GAD-7)
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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
April 27, 2023
Sponsor
Talkspace
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05467787
Brief Title
Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety
Official Title
Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is concerned with evaluating an innovative care delivery platform that is becoming widely available but has not been adequately evaluated in a clinical trial. Primarily, this study is concerned with whether text based care is clinically effective, and if that effect is a function of (1) intervention intensity, (2) timeliness and match of therapeutic recommendations and (3) more stable mood and function over time. Based on the existing, yet limited data in the field, there is evidence to suggest that more frequent encounters with a psychotherapist results in better treatment adherence and faster and more stable response to treatment.
Detailed Description
Mobile psychotherapies have been shown to be reliable and effective platforms for delivering evidence-based psychotherapies, and have the potential to reach millions of lives. Several recent randomized clinical trials demonstrate that mobile psychotherapy is effective for mild to moderate depression. These studies also demonstrate that mobile psychotherapy overcomes transportation, time, and stigma barriers for minority and rural individuals. These interventions are found to be culturally relevant and avoid the stigma concerns faced by many minorities and immigrant populations and improve access for those who are too physically disabled to leave home for in-person treatment. Available platforms range from fully self-guided treatment, text-based care, and telephone based psychotherapy. Although self-guided care may be the most cost efficient method of care, recent research shows that this is a highly under-utilized form of care and in soon to be released publication from our group, most patients find this a less appealing form of treatment because of the lack of accountability of the treatment and motivational issues that are a consequence of these illnesses. Indeed, other work suggests that consumer internal resources such as motivation fatigue and illness burden impact engagement with self-guided treatment. Although there is a population to which self-guided treatment may be appealing, in the broader context, access to a coach or expert is needed for these to be effective models of care. Text-based care however is becoming a widely popular and available form of psychotherapy delivery. Part of the appeal of text-based care is that consumers can access care when they need and at their convenience, and may be able to have more frequent contact with their therapists over the course of treatment. Telephone based psychotherapy is a well-established form of psychotherapy delivery, with several meta-analyses demonstrating not only clinical equivalency with face-to-face psychotherapy, but better adherence to treatment. However, most telephone-based psychotherapy is delivered in a traditional manner, with one-hour, weekly appointments. Although this is an effective manner of care, it still requires that consumers set aside time during the week to receive care and does not allow for in-the-moment care. Conceptually, text-based care has many potential therapeutic advantages over traditionally delivered telephone-based care. This model of care is similar to Ecological Momentary Intervention (EMI). This intervention model is based on the theory that interventions have their biggest clinical impact when the consumer is at their greatest level of receptivity, and through better timing and tailoring, improve the consumer's readiness to change, self-efficacy to implement the intervention and great behavioral activation in goal directed behavior. This study is concerned with evaluating an innovative care delivery platform that is becoming widely available but has not been adequately evaluated in a clinical trial. Primarily, this study is concerned with whether text based care is clinically effective, and if that effect is a function of (1) intervention intensity, (2) timeliness and match of therapeutic recommendations and (3) more stable mood and function over time. Based on the existing, yet limited data in the field, there is evidence to suggest that more frequent encounters with a psychotherapist results in better treatment adherence and faster and more stable response to treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Message-based psychotherapy (MBP)
Arm Type
Experimental
Arm Title
Video-chat psychotherapy (VCP)
Arm Type
Experimental
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)
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.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a 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.
Time Frame
Change from Baseline PHQ-9 each week for 12 weeks after treatment starts and at 6 months after treatment starts
Title
Change in Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Change from Baseline GAD-7 each week for 12 weeks after treatment starts and at 6 months after treatment starts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking 19 years old or older PHQ-9 score of at least 10 and no more than 20 Must have a valid email address Must be willing to receive assessment survey links via email Exclusion Criteria: Non-English speaking Under the age of 19 PHQ-9 score below 10 or above 20 Inability to receive emails Inability or unwilling to receive assessment survey links via email
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derrick Hull, PhD
Organizational Affiliation
Talkspace
Official's Role
Principal Investigator
Facility Information:
Facility Name
Talkspace
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

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.

Learn more about this trial

Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety

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