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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes, Anxiety, Depression

Intervention / Treatment
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* Behavioral: CBT-based Guided Self-Help


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-based guided self-help<br>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<br>* CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care<br>|
| No Intervention: No CBT intervention<br>Control group in comparison to CBT guided self-help group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management. | 18 weeks |