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Mindfulness-based Cognitive Therapy to Improve Emotional Wellbeing and Glycaemic Control in Diabetes

NCT02600091 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Mindfulness-Based Cognitive Therapy

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.

Sponsors & Collaborators

  • NHS Grampian

    collaborator OTHER_GOV

  • University of Glasgow

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Andrew Keen, PhD · NHS Grampian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT02600091 on ClinicalTrials.gov