Guided Self-help for Common Mental Disorders

Bibliotherapy Clinical Trial

— DWM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870099
• Other study ID #: 2004321422
• Secondary ID: KL2TR002530UL1TR
• Status: Completed
• Phase: N/A
• Start date: October 17, 2020
• Est. completion date: May 21, 2022

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Bibliotherapy

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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