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Clinical Trials/NCT02600091
NCT02600091CompletedNot Applicable

Exploring the Effectiveness of Mindfulness-based Cognitive Therapy to Improve Emotional Wellbeing and Glycaemic Control Among Adults With Diabetes

University of Aberdeen2 sites in 1 country29 target enrollmentStarted: October 30, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
2
Primary Endpoint
Recruitment/Retention Rates

Study Overview

Brief Summary

Type 1 and 2 diabetes are challenging conditions to manage. Anxiety and depression are common among this group and are associated with poorer diabetes control. No trials have been conducted to ascertain the effectiveness of psychological interventions designed to alleviate significant levels of anxiety and/or depression and improve glycaemic control among those with diabetes who have significant difficulties with their emotional wellbeing and diabetes control.

The aim of this project is to establish if it is feasible to run a multi-site randomised controlled trial in Scotland exploring whether an 8-week mindfulness and self-management based intervention programme decreases anxiety and/or depression, and improves diabetes control. This feasibility study, based on the MRC framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, and pave the way for a larger and definitive trial.

Detailed Description

This is a feasibility trial informed by the MRC guidelines. It is a small RCT, where participants are randomised to either the MBCT intervention or waiting list control. Participants will be receiving their diabetes care in Aberdeen and Glasgow, and randomisation will occur at each site. The participants who are allocated to the waiting list control group will receive the MBCT intervention 3 months after the intervention group complete their MBCT programme.

The investigators will recruit participants using posters and leaflets, word of mouth from diabetes professionals, and from writing to those who are eligible. All of these methods are simply to raise awareness of the study. The intervention requires considerable commitment from participants (as indicated below) and this will be fully explained and explored. It will be up to potential participants to make initial contact with the research team, at which point they will be invited to the diabetes outpatient clinic for a discussion about what the project entails, the nature of mindfulness, and to go through the usual consent procedure.

In the cases of those people who agree to participate, the investigators will write to their GP and to their diabetes consultant to let them know that their patient has enrolled in the study, and provide brief information about the project.

The MBCT intervention is manualised and delivered to groups. The aim of the MBCT intervention is to increase mindfulness skills and to facilitate their use in relation to emotional wellbeing and diabetes self-management. Participants will attend on 8 occasions, once per week, for 2 hours. These meetings will have a standard structure. First, participants will describe their efforts to practice mindfulness at home over the previous week, followed by discussion of an educational topic relevant to the aims of the course. Finally, the group will do a mindfulness practice together, and the home practice for the following week will be set. In-between meetings, participants are asked to practice mindfulness by listening to an audio file or CD for about 30 minutes per day.

The research assistants will administer brief, self-report inventories at baseline; post-treatment and at 3 months follow-up to establish participants' level of mindfulness (Cognitive and Affective Mindfulness Scale-Revised);

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults (over the age of 18 years)
  • Type 1 or Type 2 diabetes, diagnosed at least 1 year ago
  • Mild to moderate levels of anxiety and/or depression (ie, HADS scores of ≥ 8)
  • Most recent HbA1c value of ≥ 75 mmol/mol (Type 1) or ≥ 61 mmol/mol (Type 2).

Exclusion Criteria

  • Severe mental health problems (such as severe depression with suicidal ideation, psychosis, personality disorder)
  • Terminal illness
  • Inability to give informed consent in English
  • Inability to understand written and spoken English.

Arms & Interventions

MBCT Intervention

Experimental

Participants in the Mindfulness-based Cognitive Therapy Intervention arm will receive an 8-week programme in mindfulness-based cognitive therapy

Intervention: Mindfulness-Based Cognitive Therapy (Behavioral)

Waiting List Control

No Intervention

The participants who are allocated to the waiting list control group will receive usual care. They will receive the MBCT intervention 3 months after the intervention group complete their MBCT programme.

Outcomes

Primary Outcomes

Recruitment/Retention Rates

Time Frame: 20 months

This study aims to establish if a large scale, definitive RCT of a specifically designed mindfulness-based group intervention, with self-management activation embedded within the programme structure, for adults with diabetes and significant emotional distress, is feasible, justified, and potentially cost-effective. The primary outcome, which will decide whether or not a full trial is feasible, will be based on rates of recruitment and retention of participants.

Secondary Outcomes

  • Acceptability(20 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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