Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
1 other identifier
interventional
110
1 country
1
Brief Summary
The purpose of this study is to examine how the 'Best Possible Self' (BPS) intervention influences diabetes symptomatology over a four week period by assessing stress and resilience as mediatory effects. Half of the participants will receive the BPS straight away while the other half will be put on a waiting list and will act as the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Aug 2018
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedFebruary 23, 2021
February 1, 2021
7 months
September 4, 2018
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes Symptomatology (assessed using the Diabetes Symptoms Checklist - Revised)
Subscales assess the existence of, and the distress caused by, fatigue, cognitive, pain, sensory, cardiology, ophthalmology, hypoglycaemia, and hyperglycaemia symptoms individually. For each sub-scale, participants can score between 0 and 5, with a lower score meaning fewer symptoms and less distress caused by that subset of symptoms. Subscales do not come together to create a total symptomatology score.
Four Weeks
Other Outcomes (3)
Self-Reported Stress (assessed using the Perceived Stress Scale)
Four weeks
Self-Reported Resilience (assessed using the Six-Item Brief Resilience Scale)
Four Weeks
Diabetes Risk (calculated using the Canadian Diabetes Risk Questionnaire)
Four Weeks
Study Arms (2)
Intervention
EXPERIMENTALParticipants receive a tailored version of Laura King's 'Best Possible Self' intervention: a brief, self-administered, psychological intervention. It is fundamentally a writing exercise, whereby recipients are asked to spend 10 minutes writing about their best possible future self and the steps they need to take to become that person. This helps the individual set goals while facilitating positive affect. Our version of the task has people focus on their health-related goals in particular.
Waiting List Control
NO INTERVENTIONParticipants are informed that they are on a waiting list and will receive the intervention at the end of the study.
Interventions
A writing exercise developed in 2001 by Laura King. The frequency of engagement with the exercise is down to the user's discretion though we recommend to them to write things down once every week for the duration of the study.
Eligibility Criteria
You may qualify if:
- Non-clinical sample
- Access to the internet
You may not qualify if:
- Severe mental illness (such as schizophrenia or bipolar depression)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liverpool John Moores University
Liverpool, Merseyside, L3 5AF, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kanayo F Umeh
Liverpool John Moores University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 18, 2018
Study Start
August 28, 2018
Primary Completion
March 20, 2019
Study Completion
March 20, 2019
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
We have no plans to share individual participant data.