Improving Mental Health in Diabetes: A Guided Self-Help Study
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Nov 2011
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 16, 2024
November 1, 2011
1.8 years
November 14, 2011
May 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life
18 weeks
Study Arms (2)
CBT-based guided self-help
EXPERIMENTALProviding a guided self-help booklet to patients with anxiety/depression meeting criteria, with two telephone calls by a clinician to provide support with this.
No CBT intervention
NO INTERVENTIONControl group in comparison to CBT guided self-help group
Interventions
CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care
Eligibility Criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raigmore Hospital
Inverness, Highlands, IV2 4NZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 16, 2024
Record last verified: 2011-11