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Completed

NCT Number: NCT05122429

Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind-Body Clinical Research Center

Stony Brook, New York, 11790, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

e-Health Treatment

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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