BibliotherapyDWMNCT04870099
Guided Self-help for Common Mental Disorders
A study testing Doing What Matters in Times of Stress: An Illustrated Guide in people with Bibliotherapy, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bibliotherapy
- What is being tested?
- Doing What Matters in Times of Stress: An Illustrated Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2020to 21 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least mild distress: K6 score ≥ 6
- Having reasonably regular access to the internet or a telephone
Who cannot join
- 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")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bibliotherapy
- Being tested
- Doing What Matters in Times of Stress: An Illustrated Guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doing What Matters in Times of Stress: An Illustrated GuideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline to Week 6
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 3 Months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start17 Oct 2020
- Primary completion21 Feb 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BibliotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Guided self-help
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Lorenzo Lorenzo-Luaces, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870099
- Sponsor's protocol ID
- 2004321422
- Other IDs
- KL2TR002530, UL1TR002529
- Acronym
- DWM
- Status last verified
- Jul 2025
- First submitted
- 27 Apr 2021
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Computational Social Sciences and Natural Language Processing to Optimize Engagement and Response to Low-intensity CBT for Depression and Anxiety
- ClinicalTrials.gov ID
- NCT04870099
- Acronym / sponsor ID
- DWM / 2004321422
- Conditions
- Bibliotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Guided self-help
| Arm | Type | Receives |
|---|---|---|
| Guided self-help | Experimental | Behavioral: Doing What Matters in Times of Stress: An Illustrated GuideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least mild distress: K6 score ≥ 6
- Having reasonably regular access to the internet or a telephone
Key exclusion criteria (1 listed)
- 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")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doing What Matters in Times of Stress: An Illustrated GuideFrom 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. | Behavioural | Guided self-help |
Primary outcome
6-week Change in Kessler 6 Psychological Distress Scale (K6)
Time frame: 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.
6-week Change in the WHO 5 Well-being Index (WHO-5)
Time frame: 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.
4 secondary outcomes
6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale
Time frame: Change from Baseline to Week 6
6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale
Time frame: Change from Baseline to Week 6
3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)
Time frame: Change from Baseline to 3 Months post-treatment
3-month Change in the WHO 5 Well-being Index (WHO-5)
Time frame: Change from Baseline to 3 Months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Bibliotherapy
Not yet recruiting
A Test of Acceptance-based Bibliotherapy for Hoarding Disorder
Hoarding Disorder
Recruiting
Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Sleep Disturbance, Dementia
Not yet recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Not yet recruiting
Group Reading and Oral Exercise Program for Older Adults
Oral Frailty, Depression
Recruiting
Self-helpinterventions for Parenting Couples With Couple Distress.
Marital Conflict
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doing What Matters in Times of Stress: An Illustrated Guide in people with Bibliotherapy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-week Change in Kessler 6 Psychological Distress Scale (K6) (time frame: Change from Baseline to Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.