Skip to content

STEPS study: to find out if and how to carry out a large clinical trial on stepped care treatment for depression.

Developing stepped care treatment for depression: a pilot randomised controlled trial and embedded interviews

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66346646
Enrollment
75
Registered
2014-07-02
Start date
2013-09-25
Completion date
Unknown
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (Depression) Mental and Behavioural Disorders

Interventions

Participants are randomised to two arms: intervention arm and control arm Clinical procedures in both groups are NICE-recommended treatments routinely delivered in IAPT services i.e. Cognitive Behavio
participants who recover only receive low-intensity therapy. High-intensity psychological therapy comprises between eight and 20 consultations of CBT. Control arm: Participants in the control arm

Sponsors

University of Exeter (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
A variety of patient-related data will be collected at baseline and 6 months post randomisation: 1. Severity of depressive symptoms (BDI-I) 2. Health-related quality of life (Short Form Health Survey-36) 3. Worry and anxiety (Generalised Anxiety Disorder-7) 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

MeasureTime frame
Qualitative data from semi-structured interviews on what people think of our trial methods and procedures and their views of stepped care.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026