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

Comparing Message-based Psychotherapy to Once-weekly, Video-based Psychotherapy for Moderate Depression and Anxiety: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Message-based psychotherapy (MBP); Behavioral: Video-chat Psychotherapy (VCP)

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • Talkspace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Message-based psychotherapy (MBP)	Behavioral: 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.
Experimental: Video-chat psychotherapy (VCP)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Talkspace
• Collaborators: University of Washington
• Investigators: Principal Investigator: Derrick Hull, PhD, Talkspace

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: STUDY00007239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Quantitative data is available upon reasonable request with a fully executed Data Use Agreement with Talkspace.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No