Evaluating the Efficacy of a 60-day Emotion Regulation Journal

Mental Health Clinical Trial

Official title:

Evaluating the Efficacy of a 60-day Self-guided Emotion Regulation Journal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738122
• Other study ID #: 22-0469
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: University of Victoria
• Contact: Samantha Gibson, BSc
• Phone: 705-988-4771
• Email: samanthagibson1[@]uvic.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Regulation
• Mental Health

Intervention

Other:
• 60-Day self-guided Emotion Regulation Journal
A 60-day self guided journal with activities designed to be completed daily to improve an individual's emotion regulation abilities and habits

Locations

Country	Name	City	State
Canada	Behavioural Medicine Lab - University of Victoria	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Victoria	Mathematics of Information Technology and Complex Systems, Switch Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Emotion Regulation	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
Primary	Participant Emotion Regulation	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	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?"	2 weeks, 1-month, 2-months
Secondary	Experience using journal	Usability and user experience of intervention group collected during exit interview	60 days
Secondary	Demographics	Age, preferred gender, socio-economic status, ethnicity, educational attainment, and employment status will be collected.	Baseline
Secondary	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.	2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Secondary	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.	2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Secondary	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.	2 weeks, 1-month, 2-months, and 3-month follow up for intervention group
Secondary	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.	2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
Secondary	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)?)	2 weeks, 1-month, 2-month, and 3-month follow up for intervention group
Secondary	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.	2 weeks, 1-month, 2-month, and 3-month follow up for intervention group