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Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

4. november 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

145

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Stony Brook, New York, Forenede Stater, 11790
        • Mind-Body Clinical Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: myCompass Only
Self-guided e-health treatment
Adfærdsmæssigt: e-Health Treatment
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
Eksperimentel: myCompass + Delayed Text Therapy Support
Self-guided e-health treatment with delayed (44min) text support from a therapist.
Adfærdsmæssigt: e-Health Treatment
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.
Eksperimentel: myCompass + Delayed Video Therapy Support
Self-guided e-health treatment with delayed (44min) video support from a therapist.
Adfærdsmæssigt: e-Health Treatment
Self-guided e-health treatment with two of the arms providing delayed (44min) text or video support from a therapist.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional impairment in work/school, social life, and family life change
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep Quality Change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stony Brook University

Efterforskere

  • Ledende efterforsker: Adam Gonzalez, PHD, Stony Brook University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. november 2017

Primær færdiggørelse (Faktiske)

17. december 2018

Studieafslutning (Faktiske)

17. december 2018

Datoer for studieregistrering

Først indsendt

18. oktober 2021

Først indsendt, der opfyldte QC-kriterier

4. november 2021

Først opslået (Faktiske)

16. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NNX15AN64G

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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