Bibliotherapy
Conditions
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.
Interventions
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.
Sponsors
Indiana Clinical and Translational Sciences Institute
National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Guided self-help
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-week Change in Kessler 6 Psychological Distress Scale (K6) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale | 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. |
| 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale | 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. |
| 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) | 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. |
| 3-month Change in the WHO 5 Well-being Index (WHO-5) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 141 |
| Total | 141 |
Baseline characteristics
| Characteristic | Guided Self-help |
|---|---|
| Age, Continuous | 40.36 years STANDARD_DEVIATION 13.95 |
| Kessler Psychological Distress 6 Scale (K6) | 10.99 units on a scale STANDARD_DEVIATION 3.59 |
| Race/Ethnicity, Customized Race/ethnicity Asian | 8 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 11 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 110 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other (e.g., multiracial) | 7 Participants |
| Sex/Gender, Customized Gender identity Genderqueer or non-binary | 3 Participants |
| Sex/Gender, Customized Gender identity Men | 18 Participants |
| Sex/Gender, Customized Gender identity Women | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 141 |
| other Total, other adverse events | 44 / 141 |
| serious Total, serious adverse events | 0 / 141 |
Outcome results
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.
Time frame: Change from Baseline to Week 6
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 6-week Change in Kessler 6 Psychological Distress Scale (K6) | -5.68 score on a scale (K6) | Standard Deviation 3.61 |
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.
Time frame: Change from Baseline to Week 6
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 6-week Change in the WHO 5 Well-being Index (WHO-5) | 13.61 score on a scale | Standard Deviation 18.2 |
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.
Time frame: Change from Baseline to 3 Months post-treatment
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) | -4.91 score on a scale | Standard Deviation 3.85 |
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.
Time frame: Change from Baseline to 3 Months post-treatment
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 3-month Change in the WHO 5 Well-being Index (WHO-5) | 15.95 score on a scale | Standard Deviation 17.32 |
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.
Time frame: Change from Baseline to Week 6
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale | 0.89 score on a scale | Standard Deviation 1.1 |
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.
Time frame: Change from Baseline to Week 6
Population: Note: These analyses use imputed data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Self-help | 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale | -0.46 score on a scale | Standard Deviation 1.18 |