Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BHFT - diabetes
Study information
Scientific title
IAPT 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
Acronym
Study hypothesis
A 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
The National Research Ethics Service (NRES) Southampton A 12SC0103
Study design
Randomised Control Trial- parallel groups
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Condition
Diabetes Type 2
Intervention
Clients 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 type
Other
Phase
Drug names
Primary outcome measures
Depression, 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 measures
Blood 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 trial start date
01/05/2011
Overall trial end date
30/04/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Suffering from Diabetes Mellitus Type 2
2. Experiencing low mood or anxiety
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients not suitable for IAPT Step 2 service.
Recruitment start date
01/05/2011
Recruitment end date
01/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Shinfield Health Centre
Berkshire Healthcare NHS Foundation Trust
South Reading Surgery
257 Whitley wood Road
Reading
RG2 9EH
United Kingdom
Funders
Funder type
Government
Funder name
Department of Health Pathfinder Projects
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to submit the manuscript to BMJ open, and present findings at BABCP conference as well as IAPT national planning meetings.
Intention to publish date
01/09/2015
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/24618414