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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
Information provided by (Responsible Party):
Timothy Bird, University of Manchester

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.

Condition or disease Intervention/treatment
Mental Health Wellness 1 Depression Anxiety Behavioral: Method of Levels Cognitive Therapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Patient Health Questionnaire mood subscale (PHQ-9) [ Time Frame: up to 3 months ]
  2. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: up to 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

United Kingdom
Trafford Primary Care IAPT Services
Manchester, United Kingdom, M33 6WT
Sponsors and Collaborators
University of Manchester
Principal Investigator: Warren Mansell University of Manchester
Principal Investigator: Sara Tai University of Manchester

Responsible Party: Timothy Bird, PhD Candidate, University of Manchester
ClinicalTrials.gov Identifier: NCT01554150     History of Changes
Other Study ID Numbers: 11/NW/0736
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

Keywords provided by Timothy Bird, University of Manchester:
Primary Health Care
Mental Health
Cognitive Therapy