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

University of Edinburgh

Status: Completed

Conditions: Coronary Heart Disease; Diabetes Mellitus Type 2; Depression

Treatments: Behavioral: Living Life to the Full

Study type: Interventional

Funder types: Other

Identifiers

NCT00854984

MREC: 08/H0405/39

CZH/4/462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Self-help CBT

Experimental group

Description:

A nurse supported self-help CBT intervention in addition to usual care.

Treatment:

Behavioral: Living Life to the Full

Usual care

No Intervention group