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Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease

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ClinicalTrials.gov Identifier: NCT00854984
Recruitment Status : Unknown
Verified April 2010 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : March 3, 2009
Last Update Posted : April 8, 2010
Sponsor:
Collaborators:
University of Stirling
Robert Gordon University
University of Glasgow
Chief Scientist Office of the Scottish Government
Information provided by:
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Depression Diabetes Mellitus Type 2 Coronary Heart Disease Behavioral: Living Life to the Full Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Self-help CBT
A nurse supported self-help CBT intervention in addition to usual care.
Behavioral: Living Life to the Full
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
Other Name: Five Areas
No Intervention: Usual care



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses. [ Time Frame: 13 weeks ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00854984


Contacts
Contact: Carina Hibberd, PhD +4401316509460 c.hibberd@ed.ac.uk

Locations
United Kingdom
Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University Recruiting
Aberdeen, United Kingdom, AB10 7QG
Community Health Sciences, GP Section, University of Edinburgh Recruiting
Edinburgh, United Kingdom, EH8 9DX
Sponsors and Collaborators
University of Edinburgh
University of Stirling
Robert Gordon University
University of Glasgow
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Margaret Maxwell, PhD University of Stirling

Responsible Party: Dr Margaret Maxwell, University of Stirling
ClinicalTrials.gov Identifier: NCT00854984     History of Changes
Other Study ID Numbers: CZH/4/462
MREC: 08/H0405/39
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: April 8, 2010
Last Verified: April 2010

Keywords provided by University of Edinburgh:
Depression
diabetes
Coronary heart disease
CBT
Cognitive behavioural therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Depressive Disorder
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases