NCT05122429

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

October 18, 2021

Last Update Submit

November 4, 2021

Conditions

Depressive SymptomsAnxietyStressImpairment

Outcome Measures

Primary Outcomes (2)

  • Functional impairment in work/school, social life, and family life change

    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

    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 Outcomes (3)

  • Sleep Quality Change

    Change from baseline at 1-week post treatment and 1-month post treatment

  • Fatigue Severity Change

    Change from baseline at 1-week post treatment and 1-month post treatment

  • Treatment Satisfaction

    1-week post treatment

Study Arms (3)

myCompass Only

EXPERIMENTAL

Self-guided e-health treatment

Behavioral: e-Health Treatment

myCompass + Delayed Text Therapy Support

EXPERIMENTAL

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

Behavioral: e-Health Treatment

myCompass + Delayed Video Therapy Support

EXPERIMENTAL

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

Behavioral: e-Health Treatment

Interventions

e-Health TreatmentBEHAVIORAL

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

myCompass + Delayed Text Therapy SupportmyCompass + Delayed Video Therapy SupportmyCompass Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • +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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mind-Body Clinical Research Center

Stony Brook, New York, 11790, United States

Location

Related Publications (1)

  • 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.

    PMID: 35727626DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Adam Gonzalez, PHD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2021

First Posted

November 16, 2021

Study Start

November 6, 2017

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

US(1)