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Completed

NCT Number: NCT03675165

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University

Liverpool, Merseyside, L3 5AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Best Possible Self

Behavioral

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: Best Possible Selves

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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