NCT04870099: DWM

Guided Self-help for Common Mental Disorders

Completed NA Results posted Last updated 3 August 2025

What this trial tests

NA trial testing Doing What Matters in Times of Stress: An Illustrated Guide in Bibliotherapy in 141 participants. Completed in 21 May 2022.

Timeline

17 October 2020

Primary endpoint
21 February 2022

21 May 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	141
Start date	17 October 2020
Primary completion	21 February 2022
Estimated completion	21 May 2022
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Bibliotherapy — all drugs for Bibliotherapy →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Bibliotherapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

6-week Change in Kessler 6 Psychological Distress Scale (K6) Primary · Change from Baseline to Week 6

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.

Group	Value	95% CI
Guided Self-help	-5.68	± 3.61

6-week Change in the WHO 5 Well-being Index (WHO-5) Primary · Change from Baseline to Week 6

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.

Group	Value	95% CI
Guided Self-help	13.61	± 18.20

6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale Secondary · Change from Baseline to Week 6

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.

Group	Value	95% CI
Guided Self-help	0.89	± 1.10

6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale Secondary · Change from Baseline to Week 6

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.

Group	Value	95% CI
Guided Self-help	-0.46	± 1.18

3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) Secondary · Change from Baseline to 3 Months post-treatment

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.

Group	Value	95% CI
Guided Self-help	-4.91	± 3.85

3-month Change in the WHO 5 Well-being Index (WHO-5) Secondary · Change from Baseline to 3 Months post-treatment

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.

Group	Value	95% CI
Guided Self-help	15.95	± 17.32

Adverse events — posted to ClinicalTrials.gov

Time frame: 6-week assessment period. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Guided Self-help

Serious: 0/141 (0%)

Deaths: 0/141

Other adverse events (2 terms — click to expand)

Reaction	System	Guided Self-help
Study non-response	Psychiatric disorders	—
Study non-engagement	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT04870099 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acceptability and Outcomes of Transdiagnostic Guided Self-help Bibliotherapy for Internalizing Disorder Symptoms in Adults: A Fully Remote Nationwide Open Trial.
   Lorenzo-Luaces L, Howard J, De Jesús-Romero R, Peipert A, et al · · 2023 · cited 7× · PMID 36530566 · DOI 10.1007/s10608-022-10338-5
2. Emotion regulation as a mechanism of change in transdiagnostic low-intensity cognitive behavioral therapy for internalizing distress: Disaggregating within vs. between individual
   De Jesús-Romero R, Starvaggi I, Howard J, Peipert A, et al · · 2022 · DOI 10.31234/osf.io/t6ymw