Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03675165|
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Best Possible Self||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience|
|Actual Study Start Date :||August 28, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
Behavioral: Best Possible Self
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.
Other Name: Best Possible Selves
No Intervention: Waiting List Control
Participants are informed that they are on a waiting list and will receive the intervention at the end of the study.
- Diabetes Symptomatology (assessed using the Diabetes Symptoms Checklist - Revised) [ Time Frame: Four Weeks ]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.
- Self-Reported Stress (assessed using the Perceived Stress Scale) [ Time Frame: Four weeks ]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.
- Self-Reported Resilience (assessed using the Six-Item Brief Resilience Scale) [ Time Frame: Four Weeks ]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.
- Diabetes Risk (calculated using the Canadian Diabetes Risk Questionnaire) [ Time Frame: Four Weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675165
|Contact: Benjamin D Gibsonfirstname.lastname@example.org|
|Liverpool John Moores University||Recruiting|
|Liverpool, Merseyside, United Kingdom, L3 5AF|
|Contact: Benjamin D Gibson|
|Study Director:||Kanayo F Umeh||Liverpool John Moores University|