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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-13

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Diabetes Mellitus Type 2 Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-help CBT

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

Group Type EXPERIMENTAL

Living Life to the Full

Intervention Type BEHAVIORAL

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

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Living Life to the Full

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Five Areas

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No