Low-intensity Stepped Care for Internalizing Distress

NCT05441111 | Completed Phase 2

• 1 other identifier: 11997
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Anxiety; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

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

  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 weeks

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

  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.

  6 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Behavioral: Common Elements Toolbox; Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide; Behavioral: Guided self-help

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)

Behavioral: Common Elements Toolbox; Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide

Interventions

Common Elements Toolbox BEHAVIORAL

COMET consists of the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. Participants complete these COMET modules by themselves. The format is reading psychoeducational along with completing specific activities

Also known as: COMET, Single-session intervention

COMET + guided self-help bibliotherapy; COMET + unguided self-help bibliotherapy

Doing What Matters in Times of Stress: An Illustrated Guide BEHAVIORAL

From the WHO's website: Doing What Matters in Times of Stress: An Illustrated Guide is a stress management guide for coping with adversity. The guide aims to equip people with practical skills to help cope with stress. A few minutes each day are enough to practice the self-help techniques. The guide can be used alone or with the accompanying audio exercises. Informed by evidence and extensive field testing, the guide is for anyone who experiences stress, wherever they live and whatever their circumstances.

Also known as: Self-help Plus

COMET + guided self-help bibliotherapy; COMET + unguided self-help bibliotherapy

Guided self-help BEHAVIORAL

Participants in the guided self-help condition are assigned an "eCoach" who provides emotional support as well as who promote adherence to the intervention

COMET + guided self-help bibliotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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")

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47408, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor Pyschological and Brain Sciences

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 29, 2022
• Primary Completion: May 11, 2023
• Study Completion: September 22, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

US (1)