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Randomised Controlled Trial of Method of Levels Cognitive Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554150
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : July 21, 2014
Sponsor:
Information provided by (Responsible Party):
Timothy Bird, University of Manchester

Tracking Information
First Submitted Date  ICMJE March 12, 2012
First Posted Date  ICMJE March 14, 2012
Last Update Posted Date July 21, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01554150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomised Controlled Trial of Method of Levels Cognitive Therapy
Official Title  ICMJE A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mental Health Wellness 1
  • Depression
  • Anxiety
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Method of Levels Cognitive Therapy
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2014)
55
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
60
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anyone presenting to primary care services with mild to moderate mental health problems with capacity to provide informed consent and does not meet exclusion criteria.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554150
Other Study ID Numbers  ICMJE 11/NW/0736
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Bird, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Warren Mansell University of Manchester
Principal Investigator: Sara Tai University of Manchester
PRS Account University of Manchester
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP