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

University of Edinburgh49 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Depression Diabetes Mellitus Type 2 Coronary Heart Disease

Interventions

Living Life to the FullBEHAVIORAL

A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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 Outcomes

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

The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.

Time frame: 13 weeks

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

Data from ClinicalTrials.gov

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