Improving Mental Health in Diabetes: A Guided Self-Help Study
Recruitment status was Not yet recruiting
This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Improving Mental Health in Diabetes: A Guided Self-Help Study|
- Anxiety and/or depression in Type 2 Diabetes [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes
- Quality of life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: CBT-based guided self-help
Providing a guided self-help booklet to patients with anxiety/depression meeting criteria, with two telephone calls by a clinician to provide support with this.
Behavioral: CBT-based Guided Self-Help
CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care
No Intervention: No CBT intervention
Control group in comparison to CBT guided self-help group
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473017
|Contact: Eleanor Oswaldfirstname.lastname@example.org|
|Raigmore Hospital||Not yet recruiting|
|Inverness, Highlands, United Kingdom, IV2 4NZ|
|Contact: Eleanor Oswald 07584422971 email@example.com|