Randomised Controlled Trial of Method of Levels Cognitive Therapy
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|ClinicalTrials.gov Identifier: NCT01554150|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Wellness 1 Depression Anxiety||Behavioral: Method of Levels Cognitive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Method of Levels Cognitive Therapy (MOL)
Participants 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.
Behavioral: Method of Levels Cognitive Therapy
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.
Other Name: MOL
No Intervention: Contact Service
The 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.
- Patient Health Questionnaire mood subscale (PHQ-9) [ Time Frame: up to 3 months ]
- Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: up to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554150
|Trafford Primary Care IAPT Services|
|Manchester, United Kingdom, M33 6WT|
|Principal Investigator:||Warren Mansell||University of Manchester|
|Principal Investigator:||Sara Tai||University of Manchester|