Impact of ACT-based Interventions on Diabetes-related Outcomes

NCT04028427 | Completed

• 1 other identifier: RoyalHollowayU
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with insulin-treated diabetes can experience psychological difficulties associated with living with and managing the condition. Acceptance and Commitment Therapy (ACT) is being increasingly used to treat these psychological difficulties, with research in this area indicating positive psychological and diabetes-related outcomes (Gregg, Callaghan, Hayes, \& Glenn-Lawson, 2007; Shayeghian, Hassanabadi, Aguilar-Vafaie, Amiri, \& Besharat, 2016). Given the lack of psychology funding in diabetes care provision, a financially feasible theory-based intervention is much-needed (Diabetes UK, 2008). ACT may be the solution as it can be delivered in smaller modules. The study aims to investigate the effectiveness of two online ACT-based interventions (a mindfulness-based intervention \[MBI\] and a values-plus-goals intervention \[VGI\]) on wellbeing, diabetes self-management, coping style and glycaemic control among a sample of adults with insulin-treated diabetes. It also aims to examine whether the interventions are associated with changes in diabetes acceptance and valued living, and whether diabetes acceptance and valued living are associated with the aforementioned outcomes. Participants will be recruited from the diabetes outpatient clinics at Ashford and St. Peter's Hospitals NHS Foundation Trust to take part in the study. They will be randomly assigned to take part in either the MBI or VGI, which are both 4-week interventions. Participants will be asked to complete self-report questionnaires to measure their wellbeing, diabetes self-management, coping style, diabetes acceptance and valued living at the beginning of the study, at the end of the intervention and at a 1-month follow-up. Glycaemic control will be measured at the beginning of the study and at a 2-month follow up. It is hypothesised that both interventions will improve diabetes-related outcomes. It is hypothesised that MBI may be associated with increases in acceptance and more positive emotion focused coping, whereas the VGI may be associated with increased valued living and problem-focused/active coping.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Diabetes Self-Management Questionnaire

  Diabetes Self-Management Questionnaire (DSMQ; Schmitt et al., 2013) is a 16-item measure of self-care activities associated with glycaemic control. Each item is scored on a 4-point Likert scale from 'applies to me very much' (score of 3) to 'does not apply to me' (score of 0). The measure is composed of four subscales: 'Glucose Management', 'Dietary Control', 'Physical Activity' and 'Health-Care Use'. Schmitt et al. (2013) have shown that the DSMQ has good internal consistency (0.84) and significant convergent correlations with parallel scales of self-management and HbA1c levels.

  T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up)

Secondary Outcomes (5)

• Change in Well-Being Questionnaire

  T1 (start of intervention), T2 (end of intervention), T3 (1-month follow-up)

• Change in Brief COPE

  T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up)

• Change in Diabetes Acceptance Scale

  T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up)

• Change in Valued Living Questionnaire

  T1 (start of intervention), T2 (4 weeks - end of intervention), T3 (1-month follow-up)

• Change in HbA1c level

  T1 (start of intervention), T3 (2-month follow-up)

Study Arms (2)

Participants randomly assigned to VGI

EXPERIMENTAL

Behavioral: Values-plus-goals intervention

Participants randomly assigned to MBI

EXPERIMENTAL

Behavioral: Mindfulness-based intervention

Interventions

Values-plus-goals intervention BEHAVIORAL

The VGI is a four-week intervention, adapted from an existing online value-affirmation and goals intervention (Kingston \& Ellett, 2014) and an existing 'Living Well with Physical Health Conditions' programme handbook. Participants are first introduced to the concept of values as understood in Acceptance and Commitment Therapy. They are then asked to complete a card-sort task, which involves organising ten life domains according to their perceived level of importance. Participants will be asked to choose one values that is the most important and meaningful to them and to write for up to 10 minutes about it, thinking about why it is meaningful to them. Following this, participants will be given information on how to set value-based 'SMART' goals and asked to choose one to focus on over the next month. Participants will be sent a reminder e-mail every week over the 4 weeks, asking them to review their progress towards the SMART goal they set themselves.

Also known as: VGI

Participants randomly assigned to VGI

Mindfulness-based intervention BEHAVIORAL

The MBI is a four-week intervention, where participants are introduced to the concept of mindfulness and acceptance as understood in ACT (Hayes et al., 1999). They will be asked to complete a 10-minute health-focused mindfulness meditation exercise by listening to a recording of a script focusing on cultivating mindful awareness of internal experiences, particularly in relation to diabetes, and practising making room for any difficult internal experiences. This will be followed by some prompts to promote reflections related to their diabetes following the exercise. They will be asked to practise this exercise 3-4 times a week over a four-week period. As a manipulation check, participants will be sent a reminder e-mail every week over the four weeks to record how many times they practised the exercise over the past week.

Also known as: MBI

Participants randomly assigned to MBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 diabetes or type 2 diabetes treated with insulin
• Recent HbA1c value of 64 mmol/mol or higher
• At least 18 years of age
• Fluent in written and spoken English
• Access to the Internet to access the intervention

You may not qualify if:

• People with diabetes treated with diet and/or tablets alone
• Non-English speakers
• Aged under 18 years
• No Internet access
• Severe and enduring mental health problems
• Presence of another serious and/or life-threatening physical condition
• Cognitive and/or visual impairment
• Currently accessing psychological treatment

Sponsors & Collaborators

• Sophini Logeswaran: lead

Study Sites (1)

Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, KT16 0PZ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sophini Logeswaran

  Royal Holloway University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 22, 2019
• Study Start: October 14, 2019
• Primary Completion: April 30, 2020
• Study Completion: July 1, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)