Thinking about your best possible self: Using a psychological writing task to improve your diabetes self-management

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN10867442
• Date of registration: 05/07/2017
• Prospective Registration: No
• Primary sponsor: Liverpool John Moores University
• Public title: Thinking about your best possible self: Using a psychological writing task to improve your diabetes self-management
• Scientific title: Adopting the 'Best Possible Self' task to improve diabetes self-management: A randomised controlled trial
• Date of first enrolment: 03/07/2017
• Target sample size: 76
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10867442
• Study type: Interventional
• Study design: Double-blinded 3x2 randomised controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Australia, Canada, England, France, Germany, Italy, Netherlands, New Zealand, Spain, United Kingdom, United States of America

Contacts

• Name: Benjamin Gibson

• Name: Kanayo Umeh

Key inclusion & exclusion criteria

Inclusion criteria:
1. Mentally healthy adults over the age of 18 with a formal diagnosis of type 1 or type 2 diabetes
2. Participants must already be daily self-monitoring their blood sugar levels
3. They must also regularly receive HbA1c levels from their health care professional (e.g. GP or nurse)

Exclusion criteria:
1. Under the age of 18
2. Have a form of diabetes not listed in the inclusion criteria such as gestational diabetes. This is simply because they are less common, preventing an easy split of the data.
3. Anyone with an affective disorder (e.g. anxiety, depression, eating disorders; all of which are common co-morbidities of diabetes) will also be excluded because of the nature of the study (i.e. a trial with a focus on emotions and emotion induction) as they might be at too much undue risk


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 and Type 2 Diabetes
Nutritional, Metabolic, Endocrine
Type 1 and Type 2 Diabetes

Intervention(s)

Participants are randomly allocated to one of five groups based on intervention type and dosage level.

Those in the first two groups receive the ‘treatment’ condition: a tailored-for-diabetes version of the ‘Best Possible Self’ informed by feedback from diabetes patients as part of a previous study. These individuals are split based on whether they are in a ‘daily’ group or a ‘twice weekly’ group which indicates how frequently they have to do the task. This involves completing a series of questionnaires online that measures aspects of your self-management care and general well-being.

The next two groups receive the ‘placebo’ condition: a standard version of the ‘Best Possible Self’ task. They too are split into separate ‘daily’ or ‘twice weekly’ groups.

The fifth, and final, group are put on a waiting list; they act as the ‘control’ condition. All participants (with the exception of the placebo group) complete the task as frequently as they have been told to do for a period of four weeks. All participants (including the placebo group) are followed up at the end of this four week period.

Participants report recent blood sugar results as well as some basic personal information such as age, gender, ethnicity, and BMI.

Randomisation is handled by the Qualtrics software that hosts the trial. The software evenly presents information so that each group should have the same number of participants. Using the software to randomise group allocation allows the study to be double-blinded.

Primary Outcome(s)

1. Positive psychological changes are measured using the PANAS questionnaire at baseline, immediately after allocation to assess exposure effects, and trial end (end of week 4)
2. Depression and anxiety levels are measured using the HADS questionnaire at baseline and trial end (end of week 4)
3. Self-Management behaviours are measured using the DSMQ questionnaire at baseline and trial end (end of week 4)

Secondary Outcome(s)

1. Blood sugar control is measured using changes in daily self-reported blood sugar results and changes in HbA1c results (if available) across the duration of the trial. Participants provide their last fasting and pre-prandial blood sugar results at baseline and then self-report subsequent results once a week in response to a reminder email. They provide their previous HbA1c at baseline and report any changes (if there were any during the trial period) at trial end (end of week 4).

Secondary ID(s)

17/NSP/026

Source(s) of Monetary Support

Liverpool John Moores University

Results

• Results available: Yes
• Date Completed: 11/03/2019