NCT05738109

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 14, 2024

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

February 3, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

mental healthself-careself-talkpilot trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

    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

    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

    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.

    At 3 months from baseline or if and when intervention participants drop out of the study

  • +4 more secondary outcomes

Study Arms (2)

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

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.

Interventions

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.

Self-guided journaling Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioural Medicine Lab UVic

Victoria, British Columbia, V8p5C2, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Ryan Rhodes, PhD

    Lab Director and Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 21, 2023

Study Start

September 13, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 14, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations