Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Feb 2020
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedApril 28, 2023
April 1, 2023
9 months
July 18, 2022
April 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 from Baseline PHQ-9 each week for 12 weeks after treatment starts and at 6 months after treatment starts
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.
Change from Baseline GAD-7 each week for 12 weeks after treatment starts and at 6 months after treatment starts
Study Arms (2)
Message-based psychotherapy (MBP)
EXPERIMENTALVideo-chat psychotherapy (VCP)
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- English speaking
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talkspacelead
- University of Washingtoncollaborator
Study Sites (1)
Talkspace
New York, New York, 10025, United States
Related Publications (1)
Song J, Litvin B, Allred R, Chen S, Hull TD, Arean PA. Comparing Message-Based Psychotherapy to Once-Weekly, Video-Based Psychotherapy for Moderate Depression: Randomized Controlled Trial. J Med Internet Res. 2023 Jun 29;25:e46052. doi: 10.2196/46052.
PMID: 37384392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derrick Hull, PhD
Talkspace
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 21, 2022
Study Start
February 8, 2020
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.