- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738122
Evaluating the Efficacy of a 60-day Emotion Regulation Journal
April 4, 2025 updated by: University of Victoria
Evaluating the Efficacy of a 60-day Self-guided Emotion Regulation Journal
Participants randomized to the intervention group will receive a physical copy of the 60-day emotion regulation journal during the baseline meeting.
Participants will also be introduced the purpose of the journal and its intended usage (i.e., daily journaling).
Intervention participants will not be offered guidance or feedback on the journal after these initial instructions, in order to emulate an ad libitum usage.
Control group participants will not receive any contact with the researchers outside of the planned questionnaires and to receive their journal at the two-month timepoint.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8P 5C2
- Behavioural Medicine Lab - University of Victoria
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- (1) being 18+ years old (2) being fluent in English, (3) currently living in the Greater Victoria area, (4) self-reporting no previously diagnosed mental illness or psychiatric conditions, and (5) scoring a mean of <4.6 on the Cognitive Reappraisal, and mean of >3.14 on the Expressive Suppression subscales of the Emotion Regulation Questionnaire (based on previous mean data)
Exclusion Criteria:
- Scoring a mean of ≥4.6 on the Cognitive Reappraisal or a mean of ≤3.14 on the Expressive Suppression subscales of the Emotion Regulation Questionnaire, currently receiving or seeking therapy for a mental illness, a current or previous diagnosis of mental illness, or self-identifying as neurodivergent.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (Journal Group)
Participants in the Intervention group are provided with the 60-day self-guided emotion regulation journals upon enrolment in the study.
These participants complete surveys at 2 weeks, 1 month, and 2 months.
After the 60-day period, these participants also complete an exit interview and a follow-up survey.
|
A 60-day self guided journal with activities designed to be completed daily to improve an individual's emotion regulation abilities and habits
|
|
No Intervention: Control (Waitlist Group)
Participants in the Waitlist group complete a 2-week, 1-month and 2-month survey.
After the 60-day period, they receive access to the 60-day self-guided emotion regulation journal for their own use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Emotion Regulation
Time Frame: 2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
|
Change in participants' emotion regulation abilities and habits assessed using the Emotion Regulation Questionnaire.
|
2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
|
|
Participant Emotion Regulation
Time Frame: 2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
|
Change in participants' emotion regulation abilities and habits assessed using the using the Difficulties in Emotional Regulation.
|
2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 2 weeks, 1-month, 2-months
|
Participants' adherence to the 60-days of activities in the journal assessed using three items: "Currently, what is the last day of the journal you have completed?";
"Have you skipped or not completed any days prior to the latest day you have completed?";
and "Approximately how many minutes do you spend completing a day, within the journal?"
|
2 weeks, 1-month, 2-months
|
|
Experience using journal
Time Frame: 60 days
|
Usability and user experience of intervention group collected during exit interview
|
60 days
|
|
Demographics
Time Frame: Baseline
|
Age, preferred gender, socio-economic status, ethnicity, educational attainment, and employment status will be collected.
|
Baseline
|
|
Mental Health
Time Frame: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale.
There is a minimum score of 0 and a maximum score of 21 for each anxiety and depression.
Individuals with a score of greater than 8 are considered to have considerable symptoms of anxiety and/or depression.
|
2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
|
Subjective Well-Being
Time Frame: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
Subjective well-being will be assessed using the Warwick-Edinburgh Mental Wellbeing Scale.
There is a minimum score of 14 and a maximum score of 70.
Scores above 51 are above mean population mental well-being while a score below 51 is below mean population mental well-being.
|
2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
|
Self-Compassion
Time Frame: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
Self-Compassion will be assessed using the full version of the Self-Compassion Scale.
Minimum score is 1 and Maximum score is 5. Scores from 1-2.5 indicate low self-compassion, 2.5-3.5 indicates moderate, and 3.5-5 indicates high self-compassion.
|
2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
|
|
Physical Activity and Sedentary Behaviour
Time Frame: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
Past week hours of sitting, walking, mild, moderate, and vigorous physical activity will be assessed using a modified version of the International Physical Activity Questionnaire.
A HIGH score consists of vigorous intensity activity on at least 3 days OR 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities.
A MODERATE score consists of 3 or more days of vigorous intensity activity and/or walking of at least 30 minutes per day OR 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate intensity or vigorous intensity activities.
A LOW score is not achieving the high or moderate physical activity levels.
|
2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
|
Screen Time
Time Frame: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
Past week average weekday and weekend occupational and recreational (i.e., leisure) screen time hours will be assessed using four bespoke items (e.g., In the last seven days, on an average weekday, how many hours did you spend using screens for recreational purposes (e.g., watching TV, playing video games)?)
|
2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
|
Sleep
Time Frame: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
Past week average hours of sleep will be assessed using an adapted item from the Pittsburgh Sleep Quality Assessment: 20 "During the past week, how many hours of actual sleep did you get at night?".
The minimum score is 0 representing 7 or more hours of sleep and the maximum score is 3 representing less than 5 hours of sleep.
The higher the score, the worse the sleep duration.
|
2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan E Rhodes, PhD, University of Victoria
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)
January 18, 2023
Primary Completion (Actual)
November 11, 2023
Study Completion (Actual)
November 11, 2023
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
February 17, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 4, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 22-0469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on 60-Day self-guided Emotion Regulation Journal
-
Texas Tech UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Pennington...RecruitingOverweight Adolescents | Obese AdolescentsUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)CompletedOverweight | Eating DisordersUnited States
-
University of Auckland, New ZealandCompleted
-
Alexandros Lordos, PhDUniversity of Rwanda; Centre for Sustainable Peace and Democratic Development; Interpea...CompletedAggression | Depression | Stress Disorders, Post-Traumatic | Anxiety | Mental Health | Substance-related Disorders | Psychological Trauma | Psychosocial FunctioningRwanda
-
University of BernCompletedUnipolar Depression | Adjustment Disorder | Anxiety DisorderSwitzerland
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Johannes Gutenberg University MainzNot yet recruitingMental Health
-
University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedOverweight and Obesity | Type2 DiabetesUnited States
-
Eva HeimRecruitingComplex Post-Traumatic Stress DisorderSwitzerland, Germany
-
University of Vermont Medical CenterNot yet recruiting