NCT02600091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

November 4, 2015

Last Update Submit

May 8, 2018

Conditions

AnxietyDepressionDiabetes

Keywords

AnxietyDepressionType 1 DiabetesMindfulness-based Cognitive TherapyGlycaemic control

Outcome Measures

Primary Outcomes (1)

  • Recruitment/Retention Rates

    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.

    20 months

Secondary Outcomes (1)

  • Acceptability

    20 months

Study Arms (2)

MBCT Intervention

EXPERIMENTAL

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

Behavioral: Mindfulness-Based Cognitive Therapy

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.

Interventions

Mindfulness-Based Cognitive TherapyBEHAVIORAL

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.

Also known as: MBCT
MBCT Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (7)

  • Feldman GC, Hayes AM, Kumar SM, Greeson JM, Laurenceau JP. Mindfulness and emotion regulation: the development and initial validation of the Cognitive and Affective Mindfulness Scale-revised (CAMS-R) Journal of Psychopathology and Behavioral Assessment 29 (3): 177-190 , 2007

    BACKGROUND

  • Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.

    PMID: 7555499BACKGROUND

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND

  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND

  • Bradley C. The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Reseacrh and Practice. Edited by Bradlet C, Chur, Switzerland: Harwood Academic Publishers. 1994

    BACKGROUND

  • EuroQuol Group. EQ-5D-5L User Guide. Available from http://www.euroqol.org/fileadmin/user_upload/Documenten/PDF/Folders_Flyers/EQ-5D-5L_UserGuide_2015.pdf. Last accessed November 2015

    BACKGROUND

  • Gonder-Frederick LA, Schmidt KM, Vajda KA, Greear ML, Singh H, Shepard JA, Cox DJ. Psychometric properties of the hypoglycemia fear survey-ii for adults with type 1 diabetes. Diabetes Care. 2011 Apr;34(4):801-6. doi: 10.2337/dc10-1343. Epub 2011 Feb 23.

    PMID: 21346182BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionDiabetes MellitusDiabetes Mellitus, Type 1

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andrew Keen, PhD

    NHS Grampian

    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

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 9, 2015

Study Start

October 30, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 9, 2018

Record last verified: 2017-10

Locations

GB(1)