Impact of ACT-based Interventions on Diabetes-related Outcomes

NCT04028427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-10-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Values-plus-goals intervention

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.

BEHAVIORAL

Mindfulness-based intervention

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.

Sponsors & Collaborators

  • Sophini Logeswaran

    lead OTHER

Principal Investigators

  • Sophini Logeswaran · Royal Holloway University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2020-04-30
Completion
2020-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028427 on ClinicalTrials.gov