Diabetes Mellitus, Type 2NCT03675165
Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
A study testing Best Possible Self in people with Diabetes Mellitus, Type 2, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Best Possible Self
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-clinical sample
- 18+
- Access to the internet
Who cannot join
- Severe mental illness (such as schizophrenia or bipolar depression)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 5AF
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Best Possible Self
- Keywords
- Prevention, Psychology, Self-Management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Possible SelfBehavioural
Also called Best Possible Selves
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Best Possible Self |
| Waiting List Control | No intervention | Participants are informed that they are on a waiting list and will receive the intervention at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start28 Aug 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Gibson, Liverpool John Moores University
- Investigators
- Kanayo F Umeh, Study director, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675165
- Sponsor's protocol ID
- 18/NSP/067
- Status last verified
- Feb 2021
- First submitted
- 4 Sep 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can You Reduce Diabetes Symptomatology by Becoming Your 'Best Possible Self': The Role of Stress and Resilience
- ClinicalTrials.gov ID
- NCT03675165
- Acronym / sponsor ID
- 18/NSP/067
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Prevention, Psychology, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Best Possible SelfParticipants 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. |
| Waiting List Control | No intervention | –Participants are informed that they are on a waiting list and will receive the intervention at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-clinical sample
- 18+
- Access to the internet
Key exclusion criteria (1 listed)
- Severe mental illness (such as schizophrenia or bipolar depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Possible SelfAlso: Best Possible SelvesA 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. | Behavioural | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Study linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. We have no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanayo F Umeh study director
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Possible Self in people with Diabetes Mellitus, Type 2, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Symptomatology (assessed using the Diabetes Symptoms Checklist - Revised) (time frame: Four Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.