- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738109
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
- Does a 91-day self-talk journal intervention improve outcomes of self-criticism, self-esteem, automatic negative self-statements, and mental health among participants using the journal over wait-list control?
- What is the adherence rate to a 91-day self-talk journal intervention?
- What were participants' experience(s) of using a 91-day self-talk journal?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Victoria, British Columbia, Canada, V8p5C2
- Behavioural Medicine Lab UVic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) being 19+ 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 >12 on the Self-Criticism subscale of the Self-Talk Scale (based on previous mean data; Brinthaupt, Hein, & Kramer, 2009).
Exclusion Criteria:
- Scoring =<12 on the Self-Talk Scale, currently receiving or seeking therapy for a mental illness, or a current or previous diagnosis of mental illness.
Study Plan
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: Self-guided journaling Intervention
Participants assigned to the waitlist group complete a 2wk, 1mo, 2mo and 3mo survey over the 91-day study period.
After the 91-days they will also complete a follow-up survey and exit interview
|
Participants randomized to the intervention group will receive a physical copy of the 91-day self-talk 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 three-month timepoint.
|
|
No Intervention: Waitlist Control
Participants assigned to the waitlist group complete a 2wk, 1mo, 2mo and 3mo survey over the 91-day study period.
After the 91-days they receive access to the 91-day Self-Talk Journal for their own personal use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Talk.
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Assessed using the Self-Talk Scale. The scale consists of 16 items rated on a five-point frequency scale (1 = never, 5 = very often) using the common stem "I talk to myself when…" It has a four factor-structure comprised of self-assessment, self-reinforcement, self-criticism and self-management. Total scores range from 16-80. Individual subscales scores range from 16-20. The higher the score the greater frequency of one's self-talk. |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-esteem
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Assessed using the Rosenberg Self-Esteem Scale, a 10-item measure of global self-esteem or self-worth. Uses a 4-point likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) Possible scores range from 10-40, higher scores indicate higher levels of self-esteem |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
|
Self-consciousness
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Aspects of self-consciousness, including private self-consciousness, internal state awareness, self-reflection, public self-consciousness, and social anxiety, will be assessed using the Fenigstein Self-Consciousness Scale. The scale consists of 23 items, rated using a 5-point likert scale ranging from 0 (extremely uncharacteristic) to 4 (extremely characteristic), with higher scores denoting higher levels of self-consciousness. |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
|
Automatic Negative Self-Statements
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
The frequency of automatic negative self-statements will be assessed using the Automatic Thoughts Questionnaire, whose 30-items assess the frequency of negative self-statements associated with depression. Uses a 5-point likert scale comprised of the following: 1 = not at all, 2 = sometimes, 3 = moderately often, 4 = often , and 5 = all of the time. Possible scores range from 30-150, with higher scores indicating greater rates of negative self-statements. |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
|
Adherence to Journal
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Adherence to the journal for the intervention group will be assessed using three items:
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Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
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Experience using the journal.
Time Frame: At 3 months from baseline or if and when intervention participants drop out of the study
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Intervention group participants' experience using the journal will be assessed through a qualitative exit interview
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At 3 months from baseline or if and when intervention participants drop out of the study
|
|
Demographics
Time Frame: Baseline
|
Age, preferred gender, socio-economic status, ethnicity, educational attainment, and employment status will be collected
|
Baseline
|
|
Mental Health
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale. Possible scores for each subscale range from 0-21. A score of 0-7 = "normal", 8-10 = "Borderline abnormal (borderline case)" and 11-21 = "Abnormal (case)." |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
|
Subjective Well-Being
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
Subjective well-being will be assessed using the Warwick-Edinburgh Mental Wellbeing Scale. Uses a 5-point Likert scale: 1= none of the time, 2= rarely, 3 = some of the time, 4 = often, and 5 = all of the time. Possible scores range from 14 to 70, with higher scores indicating greater mental-wellbeing |
Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
|
|
Physical Activity, Sedentary Behaviour and Sleep
Time Frame: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
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Modified International Physical Activity Questionnaire includes open-ended questions surrounding individuals':
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Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Rhodes, PhD, Lab Director and Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-0361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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