Randomised Controlled Trial of Method of Levels Cognitive Therapy
A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care
1 other identifier
interventional
55
1 country
1
Brief Summary
The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an effective intervention for treating clients with a range of presenting problems in primary care by comparing it with a waiting list control condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 21, 2014
July 1, 2014
1.3 years
March 12, 2012
July 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Health Questionnaire mood subscale (PHQ-9)
up to 3 months
Generalised Anxiety Disorder Assessment (GAD-7)
up to 3 months
Study Arms (2)
Method of Levels Cognitive Therapy (MOL)
EXPERIMENTALParticipants in this arm will be able to receive therapy over a 3 month period. They will be able to schedule sessions with a therapist as and when they need them.
Contact Service
NO INTERVENTIONThe Contact Service arm is effectively a waiting list control. Participants assigned this arm will remain on the service's waiting list during the 3 months of the therapy phase. These participants will have access to a 'Contact Service' provided by the study therapist, where they are able to contact him if they want further information about the study or their treatment options.
Interventions
In MOL the therapist has two goals: to get the client to talk about his or her problem as it is currently being experienced, and to ask about disruptions, which are thought to indicate background thoughts coming into awareness. The assumption is that when somebody is experiencing problems that they feel they cannot solve, the only way for these to be properly resolved is for change to come from within that person. The MOL therapist helps the person redirect their awareness to think about the problem in more productive ways. It is present-focused, with the therapist asking questions relating to process rather than content. The therapist does not give advice and there is no homework. In MOL clients schedule sessions as and when they feel they need them and decide how long each session should be.
Eligibility Criteria
You may not qualify if:
- Has been accepted into secondary care services.
- Aged under 16 years.
- Have an organic basis for their mental health problems. That is, mental health problems that are primarily caused by an identifiable brain malfunction such as thyroid problems or brain injury.
- Unable to provide informed consent.
- Is not able to speak, read, write or understand written and verbal English.
- Individuals who will be unable to understand and/or answer therapist questions due to learning disabilities, brain injury or similar neurological difficulties.
- Cannot attend sessions at the appropriate clinic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Trafford Primary Care IAPT Services
Manchester, M33 6WT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren Mansell
University of Manchester
- PRINCIPAL INVESTIGATOR
Sara Tai
University of Manchester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 14, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 21, 2014
Record last verified: 2014-07