Guided Self-help for Common Mental Disorders

NCT04870099 | Completed Results

• 3 other identifiers: 2004321422KL2TR002530UL1TR002529
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Common mental disorders (CMDs) like depression and anxiety account for a large proportion of disability worldwide. Access to effective treatments like cognitive-behavioral therapy (CBT) is limited and has not reduced the public health burden of psychopathology. For patients with mild-moderate CMDs, lower-intensity treatments like guided self-help CBT (GSH-CBT) are effective and more scalable (e.g., via the internet). The advent of social media has opened avenues for dissemination of GSH-CBTs and allows for passive sensing of mood, thinking, behavior, and social networks. We propose to leverage a social media platform used by over a fifth of the United States (Twitter) as a recruitment tool to virtually screen over 150 individuals, recruit N=60 to a 5-week course of GSH-CBT, and extract social media data from individuals engaged in GSH-CBT. Sociodemographic and social media data will be used to predict engagement, outcomes, and processes in GSH-CBT.

Conditions

Bibliotherapy

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.

  Change from Baseline to Week 6

• 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.

  Change from Baseline to Week 6

Secondary Outcomes (4)

• 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale

  Change from Baseline to Week 6

• 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale

  Change from Baseline to Week 6

• 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)

  Change from Baseline to 3 Months post-treatment

• 3-month Change in the WHO 5 Well-being Index (WHO-5)

  Change from Baseline to 3 Months post-treatment

Study Arms (1)

Guided self-help

EXPERIMENTAL

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

Interventions

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.

Guided self-help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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: 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
• Indiana Clinical and Translational Sciences Institute: collaborator
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47408, United States

Location

Results Point of Contact

• Title: Prof. Lorenzo Lorenzo-Luaces, Assistant Professor
• Organization: Indiana University

lolorenz@indiana.edu

8123456193

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Pyschological and Brain Sciences

Model Details: Guided self-help

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: October 17, 2020
• Primary Completion: February 21, 2022
• Study Completion: May 21, 2022
• Last Updated: August 3, 2025
• Results First Posted: July 11, 2023

Record last verified: 2025-07

Locations

US (1)