Clinical trial NCT00854984: Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
Official title: Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Diabetes Mellitus Type 2
Coronary Heart Disease
Keywords: Depression
diabetes
Coronary heart disease
CBT
Cognitive behavioural therapy
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: Robert Gordon University
name: University of Glasgow
name: Chief Scientist Office of the Scottish Government
First posted: 2009-03-03
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
timeFrame: 13 weeks
Secondary outcomes:
measure: 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).
timeFrame: 13 weeks
measure: The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.
timeFrame: 13 weeks
measure: 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.
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University
city: Edinburgh
country: United Kingdom
facility: Community Health Sciences, GP Section, University of Edinburgh
Study officials:
affiliation: University of Stirling
name: Margaret Maxwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: