Writing for adults with type 2 diabetes

ISRCTN	ISRCTN18442976
DOI	https://doi.org/10.1186/ISRCTN18442976
Secondary identifying numbers	NA.

Submission date: 05/10/2009
Registration date: 11/11/2009
Last edited: 25/05/2016

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

Not provided at time of registration

Contact information

Miss Kathryn Dennick
Scientific

Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	K.J.Dennick@warwick.ac.uk

Study information

Study design	Single centre parallel group exploratory randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Written emotional disclosure for adults with type 2 diabetes: a single centre parallel group randomised controlled trial
Study acronym	NA.
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2009
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	142 (71 per group)
Key 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)
Key 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)
Date of first enrolment	01/02/2009
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Warwick Medical School

Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

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

Website	http://www2.warwick.ac.uk/
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

University/education

University of Warwick (UK)
Private sector organisation / Universities (academic only)

Alternative name(s): The University of Warwick, Warwick
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results:	01/04/2015		Yes	No

Editorial Notes

25/05/2016: Publication reference added