NCT03675165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

September 4, 2018

Last Update Submit

February 22, 2021

Conditions

Keywords

PreventionPsychologySelf-Management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four Weeks

Other Outcomes (3)

  • Self-Reported Stress (assessed using the Perceived Stress Scale)

    Four weeks

  • Self-Reported Resilience (assessed using the Six-Item Brief Resilience Scale)

    Four Weeks

  • Diabetes Risk (calculated using the Canadian Diabetes Risk Questionnaire)

    Four Weeks

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Best Possible Selves
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-clinical sample
  • Access to the internet

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 5AF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kanayo F Umeh

    Liverpool John Moores University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 18, 2018

Study Start

August 28, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

We have no plans to share individual participant data.

Locations