Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/08/2015
Date assigned
02/10/2015
Last edited
02/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Abigail Wroe

ORCID ID

Contact details

School Green
Shinfield
Reading
West Berkshire RG2 9EH
Reading
West Berkshire RG2 9EH
RG2 9EH
United Kingdom

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

Sponsor information

Organisation

Department of Health

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes