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

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ClinicalTrials.gov Identifier: NCT03675165
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ben Gibson, Liverpool John Moores University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Best Possible Self Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Intervention
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.



Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675165


Contacts
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Contact: Benjamin D Gibson +447968874746 b.gibson@2016.ljmu.ac.uk

Locations
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United Kingdom
Liverpool John Moores University Recruiting
Liverpool, Merseyside, United Kingdom, L3 5AF
Contact: Benjamin D Gibson         
Sponsors and Collaborators
Liverpool John Moores University
Investigators
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Study Director: Kanayo F Umeh Liverpool John Moores University
  Study Documents (Full-Text)

Documents provided by Ben Gibson, Liverpool John Moores University:
Informed Consent Form  [PDF] September 14, 2018

Additional Information:
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Responsible Party: Ben Gibson, Principal Investigator, Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT03675165    
Other Study ID Numbers: 18/NSP/067
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plans to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ben Gibson, Liverpool John Moores University:
Prevention
Psychology
Self-Management
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases