Text Size

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

November 14, 2011
November 14, 2011
November 2011
September 2013   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Improving Mental Health in Diabetes: A Guided Self-Help Study
Improving Mental Health in Diabetes: A Guided Self-Help Study

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Anxiety
  • Depression
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
  • 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.
    Intervention: Behavioral: CBT-based Guided Self-Help
  • No Intervention: No CBT intervention
    Control group in comparison to CBT guided self-help group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
September 2013
September 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact: Eleanor Oswald 07584422971 eleanor.oswald@nhs.net
United Kingdom
 
NCT01473017
11/NHS/0055
Yes
University of Edinburgh
University of Edinburgh
Not Provided
Not Provided
University of Edinburgh
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP