STEPS study: to find out if and how to carry out a large clinical trial on stepped care treatment for depression.
Not Applicable
Completed
- Conditions
- Major Depressive Disorder (Depression)Mental and Behavioural Disorders
- Registration Number
- ISRCTN66346646
- Lead Sponsor
- niversity of Exeter (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
1. Age >17 years
2. Fulfilling criteria for DSM Major Depressive Disorder identified by standard clinical interview
3. Willing to receive either stepped care or intensive psychological therapy alone for depression
4. Registered with Improving Access to Psychological Therapies (IAPT)
Exclusion Criteria
1. Alcohol or drug dependence
2. Presenting at acute risk of suicide
3. Cognitively impaired determined by a brief assessment of cognitive function
4. A diagnosis of bipolar disorder, psychosis and/or psychotic symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A variety of patient-related data will be collected at baseline and 6 months post randomisation: <br>1. Severity of depressive symptoms (BDI-I)<br>2. Health-related quality of life (Short Form Health Survey-36) <br>3. Worry and anxiety (Generalised Anxiety Disorder-7)<br>In addition, we will collect data on the flow of participants through the trial (i.e., numbers of participants at each step) and patients' pathway through and adherence to treatment.
- Secondary Outcome Measures
Name Time Method Qualitative data from semi-structured interviews on what people think of our trial methods and procedures and their views of stepped care.