NCT05284578

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

March 8, 2022

Last Update Submit

May 30, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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

    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)

    Immediately post-intervention (assessed as a mediator)

Study Arms (3)

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.

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.

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.

Other: Control writing task

Interventions

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.

Self-compassionate 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.

Expressive writing intervention

Participants assigned to this condition were asked to engage in a neutral time management writing task.

Control writing task

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

Study Officials

  • Allison Kelly, PhD

    Associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant did not know prior to their study participation that there are three different study conditions, and they did not find out which condition they were randomized to until the end of their study participation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 17, 2022

Study Start

July 4, 2021

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations