Treating Depression and Anxiety in People who have Type 2 Diabetes Mellitus

ISRCTN ISRCTN18051923
DOI https://doi.org/10.1186/ISRCTN18051923
Secondary identifying numbers BHFT - diabetes
Submission date
13/08/2015
Registration date
02/10/2015
Last edited
08/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The most common form of diabetes in adults, type 2 diabetes mellitus (T2DM), occurs when the body does not produce enough insulin to function properly, or that the body’s cells don’t react to insulin as they should do. Many studies have shown that people suffering from long term conditions, such as T2DM, are more likely to suffer from depression and/or anxiety than the general population.
The Improving Access to Psychological Therapies (IAPT) service is a programme which offers treatments for people suffering from anxiety or depression. The aim of this study, is to find out how effective a modified programme providing interventions specifically for people suffering from type 2 diabetes and depression and/or anxiety

Who can participate?
Adults suffering from type 2 diabetes, experiencing mild to moderate depression and/or anxiety

What does the study involve?
Participants are randomly allocated into one of two groups, run by Psychological Wellbeing Practitioners (PWPs). Those running the experimental group receive additional training on working with people suffering from T2DM from healthcare professionals, so that both the diabetes and the psychological factors can be treated at the same time.

What are the possible benefits and risks of participating?
The benefit of taking part in the study is that people in the intervention group will receive a treatment for depression and anxiety that has been shown to be very effective. They also have that added benefit that they will receive help in the management of their diabetes. There are no significant risks of participating, however as therapy can raise distressing issues, people may find this distressing and would like further support within the service.

Where is the study run from?
Berkshire Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2011 to April 2013

Who is funding the study?
Department of Health Pathfinder Projects (UK)

Who is the main contact?
Dr Abigail Wroe

Contact information

Dr Abigail Wroe
Scientific

School Green
Shinfield
Reading
RG2 9EH
United Kingdom

Study information

Study designRandomised Control Trial- parallel groups
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Community
Study typeQuality of life
Scientific titleIAPT and Long Term Medical Conditions: A Randomised Control Trial to evaluate the effectiveness of a modified IAPT intervention for People who have Type 2 Diabetes Mellitus
Study objectivesA modified group intervention as reported by Wroe et al (2014) , compared to the standard group intervention, will be more effective in terms of symptoms of anxiety and depression, self-management among adults with T2DM, glycaemic control (HbA1c), and subsequent healthcare utilisation.
Ethics approval(s)The National Research Ethics Service (NRES) Southampton A 12SC0103
Health condition(s) or problem(s) studiedDiabetes Type 2
InterventionClients who experienced mild to moderate depression and/or anxiety and had a diagnosis of Type 2 Diabetes Mellitus (T2DM) are randomly allocated to either experimental group or the control group.
Control group: Received treatment as usual. This is a 6 session group course focusing on depression and anxiety, using a range of techniques: goal setting; problem solving; behavioural work; thought identification and thought challenging.
Experimental group: Received a 6 session group focusing on depression and anxiety, however participants were encouraged to think about how any low mood /anxiety was associated with management of diabetes. They were encouraged to identify and challenge thoughts related to their diabetes management, and to set goals in relation to diabetes.
Both groups are run by Psychological Wellbeing Practitioners (PWPs).
Intervention typeOther
Primary outcome measureDepression, Anxiety, Management of Diabetes. This will be measured using self-report (VAS) at baseline (pre-group), post-group (6 weeks after baseline) and at a 3 month follow up.
Secondary outcome measuresBlood sugar markers, healthcare usage at baseline (pre-group), post-group (6 weeks after baseline) and at a 3 month follow up. The measure of IFCC was a blood result obtained from GP practice.
Overall study start date01/05/2011
Completion date30/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. Suffering from Diabetes Mellitus Type 2
2. Experiencing low mood or anxiety
Key exclusion criteria1. Patients not suitable for IAPT Step 2 service.
Date of first enrolment01/05/2011
Date of final enrolment01/07/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Shinfield Health Centre
Berkshire Healthcare NHS Foundation Trust
South Reading Surgery
257 Whitley wood Road
Reading
RG2 9EH
United Kingdom

Sponsor information

Department of Health
Hospital/treatment centre

Pathfinder Study, DoH
Skipton House, 80 London Road, London SE1 6LH
London
Se 1 6LH
United Kingdom

ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

Department of Health Pathfinder Projects

No information available

Results and Publications

Intention to publish date01/09/2015
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planWe plan to submit the manuscript to BMJ open, and present findings at BABCP conference as well as IAPT national planning meetings.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2015 Yes No

Editorial Notes

08/03/2018: Publication reference added.
24/01/2018: No publications found in PubMed, verifying study status with principal investigator.