Clinical trial NCT05122429: Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies
Official title: Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Stress
Impairment
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Functional impairment in work/school, social life, and family life change
timeFrame: Change from baseline at 6-weeks assessments, 1-weeks post treatment, and 1-month post treatment
measure: Symptoms of Depression, Stress, and Anxiety Change
timeFrame: Change from baseline at 6-weeks assessments, 1-week post treatment, and 1-month post treatment
Secondary outcomes:
measure: Sleep Quality Change
timeFrame: Change from baseline at 1-week post treatment and 1-month post treatment
measure: Fatigue Severity Change
timeFrame: Change from baseline at 1-week post treatment and 1-month post treatment
measure: Treatment Satisfaction
timeFrame: 1-week post treatment
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Mind-Body Clinical Research Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Adam Gonzalez, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.