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

Study Overview
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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.

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.

Official Title
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Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression

Conditions
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Depression, Diabetes Mellitus Type 2, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Living Life to the Full


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help CBT<br>A nurse supported self-help CBT intervention in addition to usual care. | Behavioral: Living Life to the Full<br>* A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.<br>* Other names: Five Areas;|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy