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

University of Edinburgh

Status: Withdrawn

Conditions: Depression; Type 2 Diabetes; Anxiety

Treatments: Behavioral: CBT-based Guided Self-Help

Study type: Interventional

Funder types: Other

Identifiers

NCT01473017

11/NHS/0055

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CBT-based guided self-help

Experimental group

Description:

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.

Treatment:

Behavioral: CBT-based Guided Self-Help

No CBT intervention

No Intervention group

Description:

Control group in comparison to CBT guided self-help group