Back to resultsRandomised Controlled Trial of Method of Levels Cognitive Therapy
Primary Purpose
Mental Health Wellness 1, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Method of Levels Cognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Wellness 1 focused on measuring Primary Health Care, Mental Health, Cognitive Therapy
Eligibility 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.
Sites / Locations
- Trafford Primary Care IAPT Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Method of Levels Cognitive Therapy (MOL)
Contact Service
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire mood subscale (PHQ-9)
Generalised Anxiety Disorder Assessment (GAD-7)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01554150
Brief Title
Randomised Controlled Trial of Method of Levels Cognitive Therapy
Official Title
A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Depression, Anxiety
Keywords
Primary Health Care, Mental Health, Cognitive Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Method of Levels Cognitive Therapy (MOL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Contact Service
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Method of Levels Cognitive Therapy
Other Intervention Name(s)
MOL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire mood subscale (PHQ-9)
Time Frame
up to 3 months
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Mansell
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Tai
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trafford Primary Care IAPT Services
City
Manchester
ZIP/Postal Code
M33 6WT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Randomised Controlled Trial of Method of Levels Cognitive Therapy
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