- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05122429
Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies
November 4, 2021 updated by: Adam Gonzalez, Stony Brook University
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated).
The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support.
The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to test the feasibility, acceptability and efficacy of methods for delivering mental health support when real-time communication is not possible (e.g. on long duration space flights where communication lags of up to 45 minutes are anticipated).
Participants will be healthy, high functioning adults (e.g., medical residents, postdoctoral fellows in the sciences, math, and engineering) who report elevated psychological distress, mood or anxiety symptoms.
Participants will complete a self-guided online therapy program (MyCompass) and will be randomized to receive one of the following: (1) online therapy without therapist support, 2) online therapy plus therapist support via electronic text-based messaging (i.e., secure email), or 3) online therapy plus therapist support via video messaging.
Outcomes will be evaluated weekly via online self-report measures of psychological distress, mood, anxiety, number of hours and quality of sleep, fatigue, and resiliency indicators (i.e., coping and mindfulness).
The investigators will examine changes over time in outcomes across all three groups.
The investigators hypothesize that the two enhanced treatment conditions (i.e., those with therapist support) will outperform the online self-management program without support.
The investigators also predict that outcomes for the two enhanced conditions will be comparable to those reported in the literature for in-person psychotherapy programs.
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11790
- Mind-Body Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18+years old;
- Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
- current elevated distress as measured by the Depression Anxiety and Stress Scale, 21 item version(≥ 5 on DASS Depression Subscale OR ≥ 4 on DASS Anxiety Subscale OR ≥ 8 on DASS Stress Subscale) (DASS, Lovibond & Lovibond, 1995); and, (5) ≥ 5 on any subscale of the Sheehan Disability Scale (SDS, Sheehan 1983).
Exclusion Criteria:
- Any current or recent (i.e. past month) suicide ideation
- any history of suicide attempt (within past 5 years)
- serious mental illness (i.e., psychosis, mania)
- alcohol or substance dependency during the past 6 months
- serious medical problems (e.g., seizures, cancer)
- current participation in psychotherapy
- new use of psychoactive medications (i.e., benzodiazepines for less than 1 month or selective serotonin reuptake inhibitors [SSRIs], tricyclics, or serotonin-norepinephrine reuptake inhibitors [SNRIs] for less than 3 months).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: myCompass Only
Self-guided e-health treatment
|
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
|
Experimental: myCompass + Delayed Text Therapy Support
Self-guided e-health treatment with delayed (44min) text support from a therapist.
|
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
|
Experimental: myCompass + Delayed Video Therapy Support
Self-guided e-health treatment with delayed (44min) video support from a therapist.
|
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional impairment in work/school, social life, and family life change
Time Frame: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment
|
Sheehan Disability Scale is a 3 item measure to assess functional impairment in work/school, social life, and family life.
|
Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment
|
Symptoms of Depression, Stress, and Anxiety Change
Time Frame: Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment
|
Depression Anxiety and Stress Scale is a 21-item measure to assess the severity of Depression, Stress, and Anxiety.
|
Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality Change
Time Frame: Change from baseline at 1-week post treatment and 1-month post treatment
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire that assesses seven components of sleep quality (subjective sleep quality, sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction).
Each component is rated on a 0-3 severity scale referring to the frequency of each disturbance, and yields a global score with a range of 0-21.
|
Change from baseline at 1-week post treatment and 1-month post treatment
|
Fatigue Severity Change
Time Frame: Change from baseline at 1-week post treatment and 1-month post treatment
|
The Fatigue Severity Scale (FSS) measures fatigue and its effects on functioning.
The FSS is comprised of nine items rated on a Likert-type rating scale (1-7), where one indicates no impairment and seven indicates severe impairment.
|
Change from baseline at 1-week post treatment and 1-month post treatment
|
Treatment Satisfaction
Time Frame: 1-week post treatment
|
The ARMS-12 measures confidence, comfortability, and perceptions towards the program.
The ARMS-12 is comprised of 12 items rated on a Likert-type rating scale (1-7), where one indicates the how strongly the agree or disagree with the statement.
|
1-week post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam Gonzalez, PHD, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2017
Primary Completion (Actual)
December 17, 2018
Study Completion (Actual)
December 17, 2018
Study Registration Dates
First Submitted
October 18, 2021
First Submitted That Met QC Criteria
November 4, 2021
First Posted (Actual)
November 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 4, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNX15AN64G
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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