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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Edinburgh.
Recruitment status was  Not yet recruiting
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014