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Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Best Possible Self
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Prevention, Psychology, Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-clinical sample
  • 18+
  • Access to the internet

Exclusion Criteria:

  • Severe mental illness (such as schizophrenia or bipolar depression)

Sites / Locations

  • Liverpool John Moores University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waiting List Control

Arm Description

Participants 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.

Participants are informed that they are on a waiting list and will receive the intervention at the end of the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2018
Last Updated
February 22, 2021
Sponsor
Liverpool John Moores University
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1. Study Identification

Unique Protocol Identification Number
NCT03675165
Brief Title
Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
Official Title
Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The BPS is a "positive" psychology intervention; i.e. it facilitates positive emotion in order to achieve psychological, behavioural, and even physiological changes. The present team's previous research has demonstrated that the BPS is effective at reducing certain diabetes symptoms, though the exact mechanisms by which it does so are unclear. According to the Stress Buffering Model of Physical Activity, psychological stress is the catalyst that triggers behavioural and physiological responses critical to health while positive emotions can improve health by helping people to cope. The Broaden and Build Theory of Positive Emotions, meanwhile, suggests that this is because positive emotions allow people to build resilience. In this study, the aim is to examine whether stress and resilience in particular mediate the relationship between intervention and diabetes symptoms. Research around stress and resilience has shown these factors to be important not only in the physical health of people with diabetes but for also decreasing illness symptomatology in non-clinical samples more generally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Prevention, Psychology, Self-Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Waiting List Control
Arm Type
No Intervention
Arm Description
Participants are informed that they are on a waiting list and will receive the intervention at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
Best Possible Self
Other Intervention Name(s)
Best Possible Selves
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes Symptomatology (assessed using the Diabetes Symptoms Checklist - Revised)
Description
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.
Time Frame
Four Weeks
Other Pre-specified Outcome Measures:
Title
Self-Reported Stress (assessed using the Perceived Stress Scale)
Description
Mediatory Effect. Individual scores are added up and can range from 0-40. A higher score means that the individuals perceives themselves to be more stressed.
Time Frame
Four weeks
Title
Self-Reported Resilience (assessed using the Six-Item Brief Resilience Scale)
Description
Mediatory Effect. Responses are added up to give a score between 6 and 30. The total sum is then divided by 6 (the number of questions). A higher score indicates a higher level of resilience.
Time Frame
Four Weeks
Title
Diabetes Risk (calculated using the Canadian Diabetes Risk Questionnaire)
Description
Control Variable. A total risk score is assessed by summing up the scores of each of the 12 questions. Scores range from 0-87. A lower score indicates less risk. Participants with a score of < 21 are low risk, participants with a score of 21 - 32 are medium risk, and participants with a score of >32 are high risk.
Time Frame
Four Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-clinical sample 18+ Access to the internet Exclusion Criteria: Severe mental illness (such as schizophrenia or bipolar depression)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanayo F Umeh
Organizational Affiliation
Liverpool John Moores University
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 5AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no plans to share individual participant data.
Links:
URL
https://ljmupsych.qualtrics.com/jfe/form/SV_41SfG1puMuBJHEN
Description
Study link

Learn more about this trial

Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience

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