Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease
|ClinicalTrials.gov Identifier: NCT00854984|
Recruitment Status : Unknown
Verified April 2010 by University of Edinburgh.
Recruitment status was: Recruiting
First Posted : March 3, 2009
Last Update Posted : April 8, 2010
|Condition or disease||Intervention/treatment|
|Depression Diabetes Mellitus Type 2 Coronary Heart Disease||Behavioral: Living Life to the Full|
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 (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||February 2009|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
Experimental: Self-help CBT
A nurse supported self-help CBT intervention in addition to usual care.
Behavioral: Living Life to the Full
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
Other Name: Five Areas
|No Intervention: Usual care|
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854984
|Contact: Carina Hibberd, PhDfirstname.lastname@example.org|
|Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University||Recruiting|
|Aberdeen, United Kingdom, AB10 7QG|
|Community Health Sciences, GP Section, University of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH8 9DX|
|Principal Investigator:||Margaret Maxwell, PhD||University of Stirling|