Mental HealthNCT05738122
Evaluating the Efficacy of a 60-day Emotion Regulation Journal
A study testing 60-Day self-guided Emotion Regulation Journal in people with Mental Health and Emotional Regulation, run by University of Victoria at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Emotional Regulation
- What is being tested?
- 60-Day self-guided Emotion Regulation Journal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2023to 11 Nov 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural Medicine Lab - University of Victoria
Victoria, British Columbia, V8P 5C2
About this study
Official title: 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.
- Conditions
- Mental Health, Emotional Regulation
- Being tested
- 60-Day self-guided Emotion Regulation Journal
- Medical subject headings
- Psychological Well-Being, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-Day self-guided Emotion Regulation JournalOther
A 60-day self guided journal with activities designed to be completed daily to improve an individual's emotion regulation abilities and habits
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Journal Group) | Experimental | 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. Receives: Other: 60-Day self-guided Emotion Regulation Journal |
| Control (Waitlist Group) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Participant Emotion Regulation
Change in participants' emotion regulation abilities and habits assessed using the Emotion Regulation Questionnaire.
Measured: 2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
Participant Emotion Regulation
Change in participants' emotion regulation abilities and habits assessed using the using the Difficulties in Emotional Regulation.
Measured: 2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up
Secondary outcomes (9)
Adherence
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?"
Measured: 2 weeks, 1-month, 2-months
Experience using journal
Usability and user experience of intervention group collected during exit interview
Measured: 60 days
Demographics
Age, preferred gender, socio-economic status, ethnicity, educational attainment, and employment status will be collected.
Measured: Baseline
Mental Health
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.
Measured: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Subjective Well-Being
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.
Measured: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Self-Compassion
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.
Measured: 2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Physical Activity and Sedentary Behaviour
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.
Measured: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
Screen Time
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)?)
Measured: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
Sleep
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.
Measured: 2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start18 Jan 2023
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Collaborators
- Switch Research, Mathematics of Information Technology and Complex Systems
- Responsible party
- Sponsor
- Investigators
- Ryan E Rhodes, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738122
- Sponsor's protocol ID
- 22-0469
- Status last verified
- Apr 2025
- First submitted
- 3 Feb 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a 60-day Self-guided Emotion Regulation Journal
- ClinicalTrials.gov ID
- NCT05738122
- Acronym / sponsor ID
- 22-0469
- Conditions
- Mental Health, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Switch Research, Mathematics of Information Technology and Complex Systems
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 21 Feb 2023 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Journal Group) | Experimental | Other: 60-Day self-guided Emotion Regulation JournalParticipants 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. |
| Control (Waitlist Group) | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| 60-Day self-guided Emotion Regulation JournalA 60-day self guided journal with activities designed to be completed daily to improve an individual's emotion regulation abilities and habits | Other | Intervention (Journal Group) |
Primary outcome
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.
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.
9 secondary outcomes
Adherence
Time frame: 2 weeks, 1-month, 2-months
Experience using journal
Time frame: 60 days
Demographics
Time frame: Baseline
Mental Health
Time frame: 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
Self-Compassion
Time frame: 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
Screen Time
Time frame: 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
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 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ryan E Rhodes, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60-Day self-guided Emotion Regulation Journal in people with Mental Health and Emotional Regulation, run by University of Victoria 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 1 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 8 Apr 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?
Participant Emotion Regulation (time frame: 2 weeks, 1-month, 2-months, 60 day exit interview, 90 days follow up). The study lists 2 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 8 Apr 2025.