Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/10/2009
Date assigned
11/11/2009
Last edited
25/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Kathryn Dennick

ORCID ID

Contact details

Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
-
K.J.Dennick@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA.

Study information

Scientific title

Written emotional disclosure for adults with type 2 diabetes: a single centre parallel group randomised controlled trial

Acronym

NA.

Study hypothesis

Milder symptoms of depression in chronic physical conditions such as type 2 diabetes are an important and inadequately addressed problem which has significant negative consequences for the individual's experience, and the course, of the condition. This study is a trial investigating whether an intervention that has been found to improve physical and mental health for individuals with chronic conditions, Written Emotional Disclosure (WED), is similarly effective for adults with type 2 diabetes, specifically UK primary and secondary care patients. The main hypothesis is that participants who receive WED will report lower levels of depressive symptoms, and also improvements in diabetes specific emotional distress, health related quality of life, health care use, self-management behaviours, and glycaemic control (i.e. HbA1c), compared to a control group. Also planned is an assessment of quality assurance, and an investigation of pre-specified mediators and moderators of effects and cost-effectiveness. This is in order to improve understanding of how WED affects health, and identify for whom WED is most effective and whether it is cost-effective.

Ethics approval

Warwickshire NHS Research Ethics Committee approved on the 10th December 2008 (ref: 08/H1211/165). A substantial amendment was approved on the 6th July 2009.

Study design

Single centre parallel group exploratory randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Intervention: Written Emotional Disclosure. This involves writing about personal thoughts and feelings about a stressful event.
Control: A neutral writing condition in which people describe how they use their time.

Both groups write for 20 minutes per day for 3 days over the course of one week.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Symptoms of depression, measured by the CES-D at baseline and then 3 and 6 months post-intervention

Secondary outcome measures

Measured at baseline and 3 and 6 months post-intervention:
1. Diabetes specific emotional distress measured with the Problem Areas in Diabetes (PAID) Scale
2. Health care use measured with the Stanford Patient Education Research Centre Diabetes Health Care Utilisation Questionnaire
3. Diabetes self care behaviours measured with the Summary of Diabetes Self-care Activities Questionnaire (SDCAQ)
4. Glycaemic control (HbA1c) obtained from routine medical records
5. Health related quality of life measured with the EuroQoL

Overall trial start date

01/02/2009

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years, either sex
2. Have been diagnosed with type 2 diabetes for more than 6 months
3. Have scored below a cut off for significant depressive symptoms in an eligibilty check (Centre for Epidemiological Studies Depression (CES-D) questionnaire less than 16)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

142 (71 per group)

Participant exclusion criteria

1. Have received a diagnosis of psychotic or bipolar disorder
2. Are currently receiving treatment for depression
3. Are currently receiving any psychological therapy for any reason
4. Have any history of self harm, suicidal ideation or suicide attempts
5. Have received a care provider assessment as unsuitable (e.g. if they are receiving end of life care, are acutely ill or have any past or present psychological vulnerabilities)

Recruitment start date

01/02/2009

Recruitment end date

01/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Medical School
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Dr P Hedges
Coventry
CV4 8UW
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

University/education

Funder name

University of Warwick (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results: http://www.ncbi.nlm.nih.gov/pubmed/24801108

Publication citations

Additional files

Editorial Notes

25/05/2016: Publication reference added