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

NCT ID: NCT01473017

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Type 2 Diabetes Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CBT-based Guided Self-Help

Intervention Type BEHAVIORAL

CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care

No CBT intervention

Control group in comparison to CBT guided self-help group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Raigmore Hospital

Inverness, Highlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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11/NHS/0055

Identifier Type: -

Identifier Source: org_study_id

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