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Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

NCT ID: NCT05122429

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2018-12-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depressive Symptoms Anxiety Stress Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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myCompass Only

Self-guided e-health treatment

Group Type EXPERIMENTAL

e-Health Treatment

Intervention Type BEHAVIORAL

Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.

myCompass + Delayed Text Therapy Support

Self-guided e-health treatment with delayed (44min) text support from a therapist.

Group Type EXPERIMENTAL

e-Health Treatment

Intervention Type BEHAVIORAL

Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.

myCompass + Delayed Video Therapy Support

Self-guided e-health treatment with delayed (44min) video support from a therapist.

Group Type EXPERIMENTAL

e-Health Treatment

Intervention Type BEHAVIORAL

Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.

Interventions

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e-Health Treatment

Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 18+years old;
2. Masters of Art degree or higher in social/biomedical(medicine)/physical science, engineering or mathematics
3. 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

1. Any current or recent (i.e. past month) suicide ideation
2. any history of suicide attempt (within past 5 years)
3. serious mental illness (i.e., psychosis, mania)
4. alcohol or substance dependency during the past 6 months
5. serious medical problems (e.g., seizures, cancer)
6. current participation in psychotherapy
7. 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Adam Gonzalez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Gonzalez, PHD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Mind-Body Clinical Research Center

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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Luo X, Bugatti M, Molina L, Tilley JL, Mahaffey B, Gonzalez A. Conceptual Invariance, Trajectories, and Outcome Associations of Working Alliance in Unguided and Guided Internet-Based Psychological Interventions: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Jun 21;9(6):e35496. doi: 10.2196/35496.

Reference Type DERIVED
PMID: 35727626 (View on PubMed)

Other Identifiers

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NNX15AN64G

Identifier Type: -

Identifier Source: org_study_id