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Clinical Trials/NCT05441111
NCT05441111CompletedPhase 2

Combining Guided Self-help Approaches for Common Mental Disorders

Indiana University1 site in 1 country275 target enrollmentStarted: June 29, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
275
Locations
1
Primary Endpoint
6-week change in Kessler 6 Psychological Distress Scale (K6)

Study Overview

Brief Summary

The purpose of this study is to test the feasibility and efficacy of combining a single session intervention, COMET, with a self-help intervention, Doing what matters in times of stress. In step I, all individuals receive COMET. In Step II, all individuals receive Doing what matters in times of stress but are randomized 1:1 to guided (Doing what matters in times of stress with paraprofessional support) vs. unguided self-help (Doing what matters in times of stress with no support).

Detailed Description

The first page participants will see is the informed consent document describing the study, delineating risks/benefits, payment, who to contact with problems, etc. Once participants have read through the informed consent, those who wish to participate will be taken to the survey battery.

The baseline survey should take about 15 minutes to complete. Individuals who score at least a 6 on the Kessler Psychological Distress Scale (K6) are eligible to participate. After participants are deemed eligible, they will be randomized to one of 2 conditions: guided self-help bibliotherapy or unguided self-help bibliotherapy. Participants who qualify and are randomized to the guided self-help condition will provide their phone number, email, address, whether they would like the Doing what matters in times of stress book to also be mailed to them, what their preferred method of initial contact is, and a list of timeframes in which they would have the privacy to be contacted by the research team. Participants who qualify and are randomized to the unguided self-help condition will provide their phone number, email, address, and confirm whether they would like the Doing what matters in times of stress book to also be mailed to them. Participants who do not qualify will be thanked for their time and receive the link to the book so they can use it on their own time if they wish.

After filling out their contact information, eligible participants will be taken directly to the Common Elements Toolbox (COMET) intervention. The COMET intervention will be delivered via Qualtrics and will include the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. The total time for completing the COMET intervention is around 45 minutes, which means the total approximate time for completing the entire baseline assessment (survey + COMET) is around 60 minutes.

For participants in the guided self-help condition, within 1 week of completing the baseline assessment a member of the research team will either email participants to schedule a time to call, or call eligible participants to explain the study in more detail, and answer any questions they may have. Participants will be sent a welcome email with the Doing what matters in times of stress book, a copy of the informed consent, and a participation guide. Each participant will receive a unique Zoom Health link to use for participation. These calls will not be recorded. This initial call will also serve to introduce the participant to the Doing what matters in times of stress book, create a plan for using the book, and schedule the remaining calls. The welcome call should take up to 30 minutes.

For participants in the unguided condition, within 1 week of completing the baseline assessment they will be emailed a copy of the book, the informed consent statement, the Making a Plan Worksheet, and a participation guide.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •At least mild distress: K6 score ≥ 6
  • •Having reasonably regular access to the internet or a telephone

Exclusion Criteria

  • •Suicidality: on the Patient Health Questionnaire 9 (PHQ9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")

Arms & Interventions

COMET + guided self-help bibliotherapy

Experimental

Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Each participant is assigned an "eCoach" -- an undergraduate, post-baccalaureate, or graduate research assistant -- who will meet with the participant for a 60-minute welcome call describing the intervention and 3-6 sessions of guidance focused on promoting adherence to the manual and using skills in everyday life.

Intervention: Common Elements Toolbox (Behavioral)

COMET + guided self-help bibliotherapy

Experimental

Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Each participant is assigned an "eCoach" -- an undergraduate, post-baccalaureate, or graduate research assistant -- who will meet with the participant for a 60-minute welcome call describing the intervention and 3-6 sessions of guidance focused on promoting adherence to the manual and using skills in everyday life.

Intervention: Doing What Matters in Times of Stress: An Illustrated Guide (Behavioral)

COMET + guided self-help bibliotherapy

Experimental

Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Each participant is assigned an "eCoach" -- an undergraduate, post-baccalaureate, or graduate research assistant -- who will meet with the participant for a 60-minute welcome call describing the intervention and 3-6 sessions of guidance focused on promoting adherence to the manual and using skills in everyday life.

Intervention: Guided self-help (Behavioral)

COMET + unguided self-help bibliotherapy

Active Comparator

Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Participants are left to read the book on their own (i.e., without an eCoach)

Intervention: Common Elements Toolbox (Behavioral)

COMET + unguided self-help bibliotherapy

Active Comparator

Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Participants are left to read the book on their own (i.e., without an eCoach)

Intervention: Doing What Matters in Times of Stress: An Illustrated Guide (Behavioral)

Outcomes

Primary Outcomes

6-week change in Kessler 6 Psychological Distress Scale (K6)

Time Frame: 6 weeks

Changes in K6 from baseline to Week 6. The K6 is a measure of distress and the measure is scored on a scale of 0 - 24 where higher scores indicate higher distress (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

6-week change in the WHO 5 Well-being Index (WHO-5)

Time Frame: 6 weeks

Changes in WHO-5 from baseline to Week 6. The WHO-5 is a measure of well-being and the measure is scored on a scale of 0 - 100 where higher scores indicate higher satisfaction with life (i.e., are positive). Thus, higher scores relative to baseline indicate more positive outcomes.

Secondary Outcomes

  • 6-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale(6 weeks)
  • 6-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale(6 weeks)
  • 3-month change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)(3 months)
  • 3-month change in the WHO 5 Well-being Index (WHO-5)(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lorenzo Lorenzo-Luaces

Assitant Professor Pyschological and Brain Sciences

Indiana University

Study Sites (1)

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