Guided Self-help for Common Mental Disorders (DWM)

Leveraging Computational Social Sciences and Natural Language Processing to Optimize Engagement and Response to Low-intensity CBT for Depression and Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Bibliotherapy
• Intervention / Treatment: Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47408
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

- 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")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Guided self-help; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale	Changes in the ERQ Reappraisal subscale from baseline to Week 6. The Reappraisal scale is a measure of regulating emotions by engaging in reappraisal (i.e., changing the one one thinks about an emotion evoking stimuli), widely considered an adaptive strategy. The measured is scored on a 1-7 scale where higher scores indicate greater use of adaptive emotion regulation strategies (i.e., positive). Thus, higher scores relative to baseline indicate more positive outcomes.	Change from Baseline to Week 6
6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale	Changes in the ERQ Suppression Scale from baseline to Week 6. The ERQ Suppression scale is a measure of regulating emotions by engaging in suppression (i.e., trying not to think or feel), which is considered a maldaptive emotion regulation strategy. The measure is scored on a scale of 1 - 7 where higher scores indicate higher use of suppression (i.e., negative). Thus, lower scores relative to baseline indicate more positive outcomes.	Change from Baseline to Week 6
3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)	Changes in K6 from baseline to 3 months after the termination of the study. 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., negative). Thus, lower scores relative to baseline indicate more positive outcomes.	Change from Baseline to 3 Months post-treatment
3-month Change in the WHO 5 Well-being Index (WHO-5)	Changes in WHO-5 from baseline to 3 months after the termination of the study. 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 3 Months post-treatment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS); Indiana Clinical and Translational Sciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2020
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): May 21, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2004321422; UL1TR002529 (U.S. NIH Grant/Contract); KL2TR002530 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No