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Randomised Controlled Trial of Method of Levels Cognitive Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Timothy Bird, University of Manchester
ClinicalTrials.gov Identifier:
NCT01554150
First received: March 12, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Mental Health Wellness 1
Depression
Anxiety
 Behavioral: Method of Levels Cognitive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • Patient Health Questionnaire mood subscale (PHQ-9) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554150

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

No publications provided

Responsible Party: Timothy Bird, PhD Candidate, University of Manchester
ClinicalTrials.gov Identifier: NCT01554150     History of Changes
Other Study ID Numbers: 11/NW/0736
Study First Received: March 12, 2012
Last Updated: January 7, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 23, 2013