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

Not Applicable

Withdrawn

• Conditions: Depression; Type 2 Diabetes; Anxiety
• Interventions: Behavioral: CBT-based Guided Self-Help

• Registration Number: NCT01473017
• Lead Sponsor: University of Edinburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-based guided self-help	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.

Primary Outcome Measures

Name	Time	Method
Anxiety and/or depression in Type 2 Diabetes	18 weeks	To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes

Secondary Outcome Measures

Name	Time	Method
Quality of life	18 weeks	To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.

Trial Locations

Locations (1)

Raigmore Hospital; 🇬🇧 Inverness, Highlands, United Kingdom