Mental HealthNCT05738109
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
A study testing Self-Talk Journals in people with Mental Health and Self Care, run by University of Victoria at 1 site in Canada.
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. 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, Self Care
- What is being tested?
- Self-Talk Journals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2022to 30 Apr 2024
- 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
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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?
Read the detailed 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.
- Conditions
- Mental Health, Self Care
- Being tested
- Self-Talk Journals
- Keywords
- mental health, self-care, self-talk, pilot trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Talk JournalsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-guided journaling Intervention | Experimental | 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 Receives: Other: Self-Talk Journals |
| Waitlist Control | No 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 receive access to the 91-day Self-Talk Journal for their own personal use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (9)
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
Experience using the journal.
Intervention group participants' experience using the journal will be assessed through a qualitative exit interview
Measured: At 3 months from baseline or if and when intervention participants drop out of the study
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.
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)."
Measured: 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
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
Measured: 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
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.
Measured: Change from baseline at 2 weeks, 1 month , 2 months, and 3 months for all participants. As well as 4 months for intervention participants
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 start13 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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
- 67 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 Rhodes, PhD, Principal investigator, Lab Director and Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738109
- Sponsor's protocol ID
- 21-0361
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2023
- Last updated
- 14 Jun 2024
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
- ClinicalTrials.gov ID
- NCT05738109
- Acronym / sponsor ID
- 21-0361
- Conditions
- Mental Health, Self Care
- Keywords
- mental health, self-care, self-talk, pilot trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Collaborators
- Switch Research, Mathematics of Information Technology and Complex Systems
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (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.
- 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?
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-guided journaling Intervention | Experimental | Other: Self-Talk JournalsParticipants 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 |
| Waitlist Control | No 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 receive access to the 91-day Self-Talk Journal for their own personal use. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Self-Talk JournalsParticipants 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. | Other | Self-guided journaling Intervention |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
Experience using the journal.
Time frame: At 3 months from baseline or if and when intervention participants drop out of the study
Demographics
Time frame: 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
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
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
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 14 Jun 2024.
- 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 Rhodes, PhD principal investigator
Lab Director and Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Talk Journals in people with Mental Health and Self Care, 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 14 Jun 2024. 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?
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). 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 14 Jun 2024.