Distress IntoleranceNCT05284578
The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance
A study testing Self-compassionate writing intervention and Expressive writing intervention in people with Distress Intolerance, run by University of Waterloo at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distress Intolerance
- What is being tested?
- Self-compassionate writing intervention and Expressive writing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2021to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Distress Intolerance
- Being tested
- Self-compassionate writing intervention, Expressive writing intervention, Control writing task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassionate writing interventionOther
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.
Expressive writing interventionOther
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.
Control writing taskOther
Participants assigned to this condition were asked to engage in a neutral time management writing task.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassionate writing intervention | Experimental | 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. Receives: Other: Self-compassionate writing intervention |
| Expressive writing intervention | Experimental | 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. Receives: Other: Expressive writing intervention |
| Control writing task | Active comparator | Participants assigned to this condition were asked to engage in a neutral time management writing task. Receives: Other: Control writing task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress Tolerance Scale
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.
Measured: Change from baseline to one week post-intervention
Distress Tolerance Scale (short form)
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.
Measured: Immediately post-intervention
Endorsement and Discomfort Scale (adapted)
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.
Measured: Immediately post-intervention
Endorsement and Discomfort Scale (adapted)
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.
Measured: One week post-intervention
Compassionate Engagement and Action Scale
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
Measured: Change from baseline to one week post-intervention
Secondary outcomes (1)
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)
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.
Measured: Immediately post-intervention (assessed as a mediator)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start4 Jul 2021
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress IntoleranceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1/3 of the study participants (43 from UWaterloo, 98 from Prolific) were placed into the self-compassionate writing intervention group, 1/3 of the study participants (42 from UWaterloo, 100 from Prolific) were placed into the expressive writing intervention group, and 1/3 of the study participants (41 from UWaterloo, 100 from Prolific) were placed into the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Kelly, University of Waterloo
- Investigators
- Allison Kelly, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284578
- Sponsor's protocol ID
- 42863
- Status last verified
- May 2025
- First submitted
- 8 Mar 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance: A Brief Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05284578
- Acronym / sponsor ID
- 42863
- Conditions
- Distress Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1/3 of the study participants (43 from UWaterloo, 98 from Prolific) were placed into the self-compassionate writing intervention group, 1/3 of the study participants (42 from UWaterloo, 100 from Prolific) were placed into the expressive writing intervention group, and 1/3 of the study participants (41 from UWaterloo, 100 from Prolific) were placed into the control group.
| Arm | Type | Receives |
|---|---|---|
| Self-compassionate writing intervention | Experimental | Other: Self-compassionate writing interventionParticipants 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. |
| Expressive writing intervention | Experimental | Other: Expressive writing interventionParticipants 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. |
| Control writing task | Active comparator | Other: Control writing taskParticipants assigned to this condition were asked to engage in a neutral time management writing task. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Self-compassionate writing interventionParticipants 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. | Other | Self-compassionate writing intervention |
| Expressive writing interventionParticipants 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. | Other | Expressive writing intervention |
| Control writing taskParticipants assigned to this condition were asked to engage in a neutral time management writing task. | Other | Control writing task |
Primary outcome
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.
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.
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.
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.
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
Allison Kelly, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassionate writing intervention and Expressive writing intervention in people with Distress Intolerance, run by University of Waterloo at 1 site in Canada.
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 3 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 4 Jun 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distress Tolerance Scale (time frame: Change from baseline to one week post-intervention). The study lists 5 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 4 Jun 2025.