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

Not Applicable

Completed

• Conditions: Depression; Diabetes Mellitus Type 2; Coronary Heart Disease
• Interventions: Behavioral: Living Life to the Full

• Registration Number: NCT00854984
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Study Start: 2009-03-13
• Primary Completion: 2009-09-30
• Study Completion: 2009-09-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-help CBT	Living Life to the Full	A nurse supported self-help CBT intervention in addition to usual care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.	13 weeks

Trial Locations

Locations (2)

Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University; 🇬🇧 Aberdeen, United Kingdom

Community Health Sciences, GP Section, University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom