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


UK Clinical Trials, clinical research

Primary Trial ID Number


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.
Research Details
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 Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Study Type
Behavioral : Living Life to the Full
Study Arm Groups : Self-help CBT

Intervention Type
See Interventions above
Primary Outcome Measures
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
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

Age Range
35 Years – N/A
Who Can Participate
Number of Participants
Participant Inclusion 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

Trial Location(s)
The University of Edinburgh
Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University
AB10 7QG
Trial Contact(s)
Primary Trial Contact
Carina Hibberd, PhD
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom

Scientific Title
Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
EudraCT Number
Not available for this trial
University of Stirling
Robert Gordon University
University of Glasgow
Chief Scientist Office of the Scottish Government
Other Study ID Numbers
University of Edinburgh

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=16177 →