Back to resultsPilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
Primary Purpose
Depression, Diabetes Mellitus Type 2, Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Living Life to the Full
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy
Eligibility Criteria
Inclusion Criteria:
- Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
- Be aged 35 or over.
- Be attending a participating primary care practice.
- Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
Exclusion Criteria:
- Unable to provide informed consent to participate
- Already receiving psychological treatment for their depression
- Have commenced treatment with an SSRI within the past 8 weeks
- Likely to have difficulty communicating by telephone
- Likely to have difficulty completing the forms and questionnaires
- Have a serious physical disorder
- Have a serious mental disorder
- Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
- Took part in an earlier related focus group
Sites / Locations
- Faculty of Health and Social Care, Garthdee Campus, Robert Gordon UniversityRecruiting
- Community Health Sciences, GP Section, University of EdinburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-help CBT
Usual care
Arm Description
A nurse supported self-help CBT intervention in addition to usual care.
Outcomes
Primary Outcome Measures
The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
Secondary Outcome Measures
The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).
The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.
A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.
Full Information
NCT ID
NCT00854984
First Posted
March 2, 2009
Last Updated
April 7, 2010
Sponsor
University of Edinburgh
Collaborators
University of Stirling, Robert Gordon University, University of Glasgow, Chief Scientist Office of the Scottish Government
1. Study Identification
Unique Protocol Identification Number
NCT00854984
Brief Title
Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
Official Title
Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Edinburgh
Collaborators
University of Stirling, Robert Gordon University, University of Glasgow, Chief Scientist Office of the Scottish Government
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.
Detailed Description
Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.
This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Diabetes Mellitus Type 2, Coronary Heart Disease
Keywords
Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-help CBT
Arm Type
Experimental
Arm Description
A nurse supported self-help CBT intervention in addition to usual care.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Living Life to the Full
Other Intervention Name(s)
Five Areas
Intervention Description
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
Primary Outcome Measure Information:
Title
The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).
Time Frame
13 weeks
Title
The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.
Time Frame
13 weeks
Title
A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
Be aged 35 or over.
Be attending a participating primary care practice.
Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
Exclusion Criteria:
Unable to provide informed consent to participate
Already receiving psychological treatment for their depression
Have commenced treatment with an SSRI within the past 8 weeks
Likely to have difficulty communicating by telephone
Likely to have difficulty completing the forms and questionnaires
Have a serious physical disorder
Have a serious mental disorder
Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
Took part in an earlier related focus group
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carina Hibberd, PhD
Phone
+4401316509460
Email
c.hibberd@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Maxwell, PhD
Organizational Affiliation
University of Stirling
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University
City
Aberdeen
ZIP/Postal Code
AB10 7QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Community Health Sciences, GP Section, University of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH8 9DX
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
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