Feasibility of a multi-site RCT exploring the effectiveness of mindfulness-based cognitive therapy to improve emotional wellbeing and glycaemic control among adults with type 1 diabetes

Aim(s):

Type 1 diabetes is a uniquely challenging condition to manage. Anxiety and depression appear significant barriers to effective self-management. We are bereft of studies examining the effectiveness of psychological interventions designed to reduce depression and/or anxiety, and improve diabetes control among adults with Type 1 diabetes with difficulties in both these areas.

The aim of this study is 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 Type 1 diabetes and significant emotional distress is feasible, justified, and potentially cost-effective.

Summary:

Participants will be adults (over the age of 18 years) with Type 1 diabetes, with mild to moderate levels of anxiety and/or depression (ie, HADS scores of ≥ 8) and a most recent HbA1c value of ≥ 80 mmol/mol. Potential participants must have been diagnosed with Type 1 diabetes for at least 1 year to allow for a period of stabilization. Exclusion criteria will include severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder; terminal illness; inability to give informed consent in English, and inability to understand written and spoken English. We will recruit participants from secondary care clinics in Aberdeen and Glasgow. These will include diabetes outpatient clinics at the JJR Macleod Centre for Diabetes, Endocrinology and Metabolism, Aberdeen as well as the Victoria Infirmary; Southern General, and Gartnavel General Hospitals in Glasgow.

The MBCT intervention has been tailored for adults with Type 1 diabetes

Outcomes will be collected via brief, self-report inventories at baseline, post-treatment and at 6 months follow-up to establish participants’: level of mindfulness (Cognitive and Affective Mindfulness Scale-Revised); diabetes-specific distress; anxiety and depression (HADS); positive emotional wellbeing (Warwick-Edinburgh Mental Wellbeing Scale; satisfaction with treatment provision (Diabetes Treatment Satisfaction Questionnaire); health-related quality of life (EQ-5D-5L), and the Fear of Hypoglycaemia Scale. During the intervention, we will also ask participants to keep a diary of the number of times they completed the formal mindfulness exercises (see below), and keep a record of attendance at group sessions. Details of the frequency of severe hypoglycaemia (defined as occasion they needed help to correct blood glucose levels); mild-moderate (self-corrected) hypoglycaemia, and the number of admissions for diabetic ketoacidosis in the 6 months preceding the beginning of the MBCT course and for the period between the end of treatment and follow-up will be collected. Baseline and 6 month HbA1c values will be recorded. Finally, we will ask participants to keep a diary of their health care use during the previous 6 months at baseline and follow-up. In addition, we will use NHS Scotland; NHS Grampian, and NHS Glasgow electronic systems (eg, SCI-Diabetes and SCI-Store) to obtain an accurate account of contact with secondary health professions. One-to-one qualitative interviews will be conducted with 10-15 participants, with equal numbers from the MBCT group and the control group, about 1 month after the end of the intervention.

Outcomes/Impact:

The design of effective treatments that improve depression and anxiety among adults with Type 1 diabetes, and which also considers important aspects of self-management of the condition itself, may not only be helpful to emotional wellbeing and general quality of life, but may also result in improved diabetes control in the shorter-term and the associated health benefits of better control in the longer-term. The results therefore are potentially important to the many 1000s of adults with Type 1 diabetes in Scotland; diabetes services involved in their care, and to NHS Scotland inpatient and outpatient costs.

Principal Investigator: University of Aberdeen/NHS Grampian

NMAHP Research Unit Collaborators: Professor Margaret Maxwell

External Collaborators: de Bruin M - University of Aberdeen, Gold A - NHS Grampian, Mercer S - University of Glasgow.

Funder: Chief Scientist Office