WRITE: Written Imaginal Thinking Exercise Study (WRITE)
Written Imaginal Thinking Exercise (WRITE) Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- University of Colorado Boulder
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English fluency
- Previous high-quality Prolific submission experience
- Elevated social anxiety symptoms
Exclusion Criteria:
- Hospitalization for psychiatric reasons within the past year
- Previous suicide attempt or self-harm
- Previous treatment for severe head injury or past repeated serious head injury
- Current psychosis symptoms
- Elevated trauma symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Worst-Case Scenario
|
Written exposure exercise about an imagined future worst-case scenario.
|
|
Active Comparator: Neutral Future Scenario
|
Written exercise about an imagined neutral future scenario.
|
|
Experimental: Best-Case Scenario
|
Written exposure exercise about an imagined future best-case scenario.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Phobia Inventory (SPIN)
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Social anxiety symptom severity, range: 0-68 total, higher scores indicate higher social anxiety symptom severity.
|
Baseline through study completion, an average of 3 weeks.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-8)
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Depression symptom severity, range: 0-24 total, higher scores indicate higher depression symptom severity.
|
Baseline through study completion, an average of 3 weeks.
|
|
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Baseline through study completion, an average of 3 weeks.
|
General anxiety symptom severity, range: 0-20 total, higher scores indicate higher general anxiety symptom severity.
|
Baseline through study completion, an average of 3 weeks.
|
|
Social Approach Motivation
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Self-reported rating of motivation for social approach over the next week.
Rating ranges from 0 (not motivated at all) to 100 (extremely motivated).
|
Baseline through study completion, an average of 3 weeks.
|
|
Positive and Negative Affect Schedule (PANAS-10)
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Positive and negative affect, range: 5-25 each (total score), higher scores indicate higher positive and negative affect.
|
Baseline through study completion, an average of 3 weeks.
|
|
Cognitive Emotion Regulation Questionnaire (CERQ): Catastrophizing and Positive Reappraisal subscales
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Use of catastrophizing and positive reappraisal cognitive emotion regulation strategies, range: 1-5 each (average score), higher score reflects higher degree of use of strategy.
|
Baseline through study completion, an average of 3 weeks.
|
|
Threat-related prediction ratings
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Self-reported ratings of 1) likelihood of feared situation avoidance, 2) likelihood of feared outcome occurrence, 3) predicted intensity of feared outcome occurrence, 4) likelihood of best possible outcome occurrence, and 5) predicted intensity of best possible outcome occurrence.
All ratings range from 0 (0% likely/not bad at all/not good at all) to 100 (100% likely/as bad as I can possibly imagine/as good as I can possibly imagine).
|
Baseline through study completion, an average of 3 weeks.
|
|
State emotion ratings
Time Frame: Baseline through study completion, an average of 3 weeks.
|
Self-reported state ratings of 1) positive affect, and 2) anxiety.
All ratings range from 0 (not positive/anxious at all) to 100 (extremely positive/anxious).
|
Baseline through study completion, an average of 3 weeks.
|
|
Writing exercise experience ratings - writing qualities
Time Frame: After each writing exercise, an average of 2 weeks.
|
Self-reported ratings of vividness/detail and effort of the writing.
All ratings range from 0 (not at all) to 100 (extremely), higher scores reflect greater vividness/detail and effort.
|
After each writing exercise, an average of 2 weeks.
|
|
Writing exercise experience ratings - perceived learning
Time Frame: After each writing exercise, an average of 2 weeks.
|
Self-reported ratings of perceived learning and perspective shift from the writing exercises.
All ratings range from 0 (strongly disagree) to 4 (strongly agree).
Higher scores reflect greater perceived learning and perspective shift.
|
After each writing exercise, an average of 2 weeks.
|
|
Behavioral approach/avoidance
Time Frame: At the final study session, approximately 3 weeks after Baseline.
|
Single self-reported rating of willingness to engage in a feared situation.
Binary yes/no response, where yes indicates willingness to approach and no indicates avoidance.
|
At the final study session, approximately 3 weeks after Baseline.
|
|
Program feedback ratings - overall
Time Frame: At the final study session, approximately 3 weeks after Baseline.
|
Ratings assessing overall program feedback (range: 0-28, higher scores reflect more positive overall program feedback).
|
At the final study session, approximately 3 weeks after Baseline.
|
|
Program feedback ratings - perceived benefit
Time Frame: At the final study session, approximately 3 weeks after Baseline.
|
Rating assessing perceived benefit of the writing exercises (range: 0-4, higher scores reflect higher perceived benefit).
|
At the final study session, approximately 3 weeks after Baseline.
|
|
Program feedback ratings - likelihood of future use
Time Frame: At the final study session, approximately 3 weeks after Baseline.
|
Rating assessing likelihood of future use of writing exercises (range: 0-100, higher scores reflect higher likelihood of future use).
|
At the final study session, approximately 3 weeks after Baseline.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 25-0771
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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