Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal

Mental Health Clinical Trial

Official title:

Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738109
• Other study ID #: 21-0361
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2022
• Source: University of Victoria
• Contact: Alyssa Manankil-Lakusta, BSc, BSFL
• Phone: 250-472-5288
• Email: manankil[@]uvic.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. 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? 2. What is the adherence rate to a 91-day self-talk journal intervention? 3. What were participants' experience(s) of using a 91-day self-talk journal?

Description:

The following research project can contribute to the investigators' understanding of how/how well self-guided resources can increase participant outcomes of self-criticism, self-esteem, automatic negative self-statements, and mental health. Self-guided resources such as a self-talk journal provide can provide an easily accessible avenue for improving individual mental health. There has been a recent surge in the popularity of health-promotive self-care products, or products aimed at providing individuals with "the knowledge, skills, and attitudes required to achieve and maintain good health". These products (often in the form of journals) are similar to "self-help books"; however, a key difference is that self-care products prompt and provide space for the reader to actively engage in activities and psychological techniques, unlike the passive nature of traditional self-help books. These products typically address mental health concerns (i.e., mental health self-care) and are advertised to provide an effective means for individuals to reduce stress, improve self-compassion, and boost wellbeing. What's more, the generally positive reviews these products garner provides the perception that these products are well-received and effective in eliciting these outcomes. However, the scientific foundation for the majority of these journals is unknown. Furthermore, the efficacy of these products for improving or promoting their intended outcome(s) is often not addressed outside of these, often positive, reviews.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2023
• Est. primary completion date: March 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 >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.

Related Conditions & MeSH terms

• Mental Health
• Self Care

Intervention

Other:
• Self-Talk Journals
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.

Locations

Country	Name	City	State
Canada	Behavioural Medicine Lab UVic	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	Self-Talk.	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	Self-esteem	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
Secondary	Self-consciousness	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
Secondary	Automatic Negative Self-Statements	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
Secondary	Adherence to Journal	Adherence to the journal for the intervention group will be assessed using three items: "Currently, what is the last day of the journal [the participant] completed?": possible score range 0-91, 0 indicates no days have been completed; "[Has the participant] skipped or not completed any days prior to the latest day [the participant] completed?": No or yes - indicate which days; "Approximately how many minutes [did the participant] spend completing a day, within the journal?": self-reported number of daily minutes	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	Experience using the journal.	Intervention group participants' experience using the journal will be assessed through a qualitative exit interview	At 3 months from baseline or if and when intervention participants drop out of the study
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.; 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
Secondary	Subjective Well-Being	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
Secondary	Physical Activity, Sedentary Behaviour and Sleep	Modified International Physical Activity Questionnaire includes open-ended questions surrounding individuals': Physical activity. Frequency score ranging from 0-7 days per week. Average time spent on one of those days ranging from 0-24 total hours. Separate questions for vigorous intensity, moderate intensity, mild intensity and walking.; Sitting reported in average hours per day ranging from 0-24 total hours.; Occupational and recreational screentime. Reported using a separate daily average for weekdays and weekends ranging from 0-24 total hours.; Sleep reported using average number of hours per night ranging from 0-24 total hours.	Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants