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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854984
• Other study ID #: CZH/4/462
• Secondary ID: MREC: 08/H0405/3
• Status: Completed
• Phase: N/A
• Start date: March 13, 2009
• Est. completion date: September 30, 2009

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 30, 2009
• Est. primary completion date: September 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Disorder
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Living Life to the Full
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.

Locations

Country	Name	City	State
United Kingdom	Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University	Aberdeen
United Kingdom	Community Health Sciences, GP Section, University of Edinburgh	Edinburgh

Sponsors (5)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government, Robert Gordon University, University of Glasgow, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.		13 weeks
Secondary	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).		13 weeks
Secondary	The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.		13 weeks
Secondary	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.		13 weeks