Improving Mental Health in Diabetes: A Guided Self-Help Study

Depression Clinical Trial

Official title:

Improving Mental Health in Diabetes: A Guided Self-Help Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01473017
• Other study ID #: 11/NHS/0055
• Status: Withdrawn
• Phase: N/A
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2011
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.

Exclusion Criteria:

• Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.

• Participants with a known Learning Disability or severe visual impairment.

• Participants who cannot read or write

• Participants under 18 years of age or over age 75

• Long-term hospital inpatients

• Individuals with a diagnosis of Diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Raigmore Hospital	Inverness	Highlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and/or depression in Type 2 Diabetes	To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes	18 weeks
Secondary	Quality of life	To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.	18 weeks