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

This study is not yet open for participant recruitment.
Verified November 2011 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01473017
First received: November 14, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Anxiety
Depression
 Behavioral: CBT-based Guided Self-Help

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Mental Health in Diabetes: A Guided Self-Help Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Anxiety and/or depression in Type 2 Diabetes [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    To see whether a CBT based guided self-help book improves anxiety and/or depression in participants with Type 2 Diabetes


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    To see whether the intervention enhances quality of life, psychological well-being and self-reported diabetes management.


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473017

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

Locations
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
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01473017     History of Changes
Other Study ID Numbers: 11/NHS/0055
Study First Received: November 14, 2011
Last Updated: November 14, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Mental Disorders
 Behavioral Symptoms
Mood Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013