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

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ClinicalTrials.gov Identifier: NCT01473017
Recruitment Status : Unknown
Verified November 2011 by University of Edinburgh.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2011
Last Update Posted : November 17, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Anxiety Depression Behavioral: CBT-based Guided Self-Help

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Mental Health in Diabetes: A Guided Self-Help Study
Study Start Date : November 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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
No Intervention: No CBT intervention
Control group in comparison to CBT guided self-help group

Primary Outcome Measures :
  1. Anxiety and/or depression in Type 2 Diabetes [ Time Frame: 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 :
  1. Quality of life [ Time Frame: 18 weeks ]
    To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473017

Contact: Eleanor Oswald 07584422971 eleanor.oswald@nhs.net

United Kingdom
Raigmore Hospital Not yet recruiting
Inverness, Highlands, United Kingdom, IV2 4NZ
Contact: Eleanor Oswald    07584422971    eleanor.oswald@nhs.net   
Sponsors and Collaborators
University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01473017     History of Changes
Other Study ID Numbers: 11/NHS/0055
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases