- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675165
Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 5AF
- Liverpool John Moores University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-clinical sample
- 18+
- Access to the internet
Exclusion Criteria:
- Severe mental illness (such as schizophrenia or bipolar depression)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Four Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Four weeks
|
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.
|
Four Weeks
|
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.
|
Four Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kanayo F Umeh, Liverpool John Moores University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18/NSP/067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on Best Possible Self
-
Philipps University Marburg Medical CenterCompleted
-
Universitat Jaume IUnknown
-
Universitat Jaume IHospital Provincial de Castellon; PREVI Clinical CenterCompletedEating Disorder | Daily ActivitiesSpain
-
Universitat Jaume ICompleted
-
Yale UniversityRecruitingBinge-Eating Disorder | Overweight or Obesity | Binge EatingUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingCervical Carcinoma | Human Papillomavirus InfectionUnited States
-
McGill UniversityCanadian Stroke NetworkCompleted
-
Bispebjerg HospitalCompleted
-
University Health Network, TorontoThe Weston A. Price FoundationRecruitingChronic Traumatic EncephalopathyCanada
-
University of Wisconsin, MadisonLoyola University Chicago; Iowa State UniversityCompletedParent-Child Relations