- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284578
The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance
September 2, 2022 updated by: Allison Kelly, University of Waterloo
The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance: A Brief Randomized Controlled Trial
Perceived emotional distress intolerance is a transdiagnostic marker of psychopathology associated with psychological and interpersonal dysfunction, and the development of interventions for perceived emotional distress intolerance is of prime importance.
One potential intervention is a behavioural experiment, i.e. a cognitive behaviour therapy technique where clients undergo an exercise designed to test a maladaptive belief, e.g., that negative emotions are unbearable, and adjust their belief to accommodate any disconfirmatory information that arises through the exercise.
This study examines the effects of a one-session self-compassion writing behavioural experiment compared to a one-session expressive writing behavioural experiment on low perceived distress tolerance.
Participants were recruited from the University of Waterloo and Prolific, and were randomly assigned to the self-compassion condition, expressive writing condition, or a control condition.
Study Overview
Status
Completed
Conditions
Detailed Description
The study consisted of two online surveys.
During the first survey, participants answered a set of questionnaires.
Then, they were prompted to think of an upsetting situation and the associated unpleasant emotions, and they were then randomly assigned to a brief self-compassionate writing, expressive writing, or neutral writing task.
They then answered a series of questionnaires immediately after completing the writing task.
During the second survey, one week later, participants answered a brief set of questionnaires.
Study Type
Interventional
Enrollment (Actual)
424
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Waterloo, Ontario, Canada, N2L3G1
- University of Waterloo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for University of Waterloo sample:
- Undergraduate students with a SONA account who are high in emotional distress intolerance (i.e. a lower-than-average score on the Distress Tolerance Scale; mean based on SONA student sample)
Inclusion Criteria for Prolific sample:
- Adults with a Prolific account who are high in emotional distress intolerance (i.e. a lower-than-average score on the Distress Tolerance Scale; mean based on Prolific sample)
- First language English speakers
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-compassionate writing intervention
Participants assigned to this intervention were asked to engage in one brief online self-compassionate writing session, where they were asked to write about and experience their feelings from the perspective of an inner compassionate observer.
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Participants assigned to this intervention were asked to engage in one brief online self-compassionate writing session, where they were asked to write about and experience their feelings from the perspective of an inner compassionate observer.
|
Experimental: Expressive writing intervention
Participants assigned to this intervention were asked to engage in one brief online expressive writing session, where they were asked to explore their deepest thoughts and emotions surrounding an upsetting situation through writing.
|
Participants assigned to this intervention were asked to engage in one brief online expressive writing session, where they were asked to explore their deepest thoughts and emotions surrounding an upsetting situation through writing.
|
Active Comparator: Control writing task
Participants assigned to this condition were asked to engage in a neutral time management writing task.
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Participants assigned to this condition were asked to engage in a neutral time management writing task.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress Tolerance Scale
Time Frame: Change from baseline to one week post-intervention
|
Self-report questionnaire with 15 questions on a 5-point Likert scale (scored 1-5, with 4 subscales).
Mean scores range from 1-5, with higher increase in score indicative of increased perceived distress tolerance.
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Change from baseline to one week post-intervention
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Distress Tolerance Scale (short form)
Time Frame: Immediately post-intervention
|
Self-report questionnaire with 4 questions on a 5-point Likert scale (scored 1-5).
Mean scores range from 1-5, with higher score indicative of greater perceived distress tolerance.
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Immediately post-intervention
|
Endorsement and Discomfort Scale (adapted)
Time Frame: Immediately post-intervention
|
Self-report questionnaire with 10 questions on a 9-point Likert scale (scored 1-9).
Total scores range from 10-90, with higher score indicative of greater acceptability of intervention.
|
Immediately post-intervention
|
Endorsement and Discomfort Scale (adapted)
Time Frame: One week post-intervention
|
Self-report questionnaire with 10 questions on a 9-point Likert scale (scored 1-9).
Total scores range from 10-90, with higher score indicative of greater acceptability of intervention.
|
One week post-intervention
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Compassionate Engagement and Action Scale
Time Frame: Change from baseline to one week post-intervention
|
Self-report questionnaire with 13 questions on a 10-point Likert scale (scored 1-10).
Three questions are reverse-scored and not included in scoring.
Total scores range from 10-100, with higher increase in score indicative of increased emotional engagement
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Change from baseline to one week post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Soothing affect measures (researcher-generated) - Adapted from the Serenity Subscale of the PANAS-X and the Safe/Warmth Positive Affect Subscale of the Types of Positive Affect Scale (TPAS)
Time Frame: Immediately post-intervention (assessed as a mediator)
|
Self-report questionnaire with 7 questions on a 5-point Likert scale (scored 1-5).
Total scores range from 7-35, with higher score indicative of more soothing affect.
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Immediately post-intervention (assessed as a mediator)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allison Kelly, PhD, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 4, 2021
Primary Completion (Actual)
July 21, 2022
Study Completion (Actual)
July 21, 2022
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 2, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 42863
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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