Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

Anxiety Clinical Trial

Official title:

Asynchronous Techniques for the Delivery of Empirically Supported Psychotherapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122429
• Other study ID #: NNX15AN64G
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: December 17, 2018

Study information

• Verified date: November 2021
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Impairment
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Mind-Body Clinical Research Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sleep Quality Change	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
Secondary	Fatigue Severity Change	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
Secondary	Treatment Satisfaction	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