Randomised Controlled Trial of Method of Levels Cognitive Therapy

Depression Clinical Trial

Official title:

A Randomised Controlled Trial Comparing Method of Levels Cognitive Therapy With a Contact Service for Improving Outcomes in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554150
• Other study ID #: 11/NW/0736
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: July 18, 2014
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health Wellness 1

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Trafford Primary Care IAPT Services	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire mood subscale (PHQ-9)		up to 3 months	No
Primary	Generalised Anxiety Disorder Assessment (GAD-7)		up to 3 months	No