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
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
Scientific
School Green
Shinfield
Reading
RG2 9EH
United Kingdom
Study information
| Study design | Randomised Control Trial- parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| 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 |
| Study objectives | 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(s) | The National Research Ethics Service (NRES) Southampton A 12SC0103 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Suffering from Diabetes Mellitus Type 2 2. Experiencing low mood or anxiety |
| Key exclusion criteria | 1. Patients not suitable for IAPT Step 2 service. |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Reading Surgery
257 Whitley wood Road
Reading
RG2 9EH
United Kingdom
Sponsor information
Hospital/treatment centre
Pathfinder Study, DoH
Skipton House, 80 London Road, London SE1 6LH
London
Se 1 6LH
United Kingdom
"ROR" |
https://ror.org/03sbpja79 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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. |
| 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.
