Acceptability and Feasibility of MOL in Acute Inpatient Units

Is Method of Levels (MOL) Therapy an Acceptable and Feasible Psychological Intervention for People in Acute Mental Health Inpatient Services: A Case Series.

The current study aims to test the acceptability and feasibility of a psychological therapy called Method of Levels (MOL) as an intervention for people in acute psychiatric inpatient units who are experiencing psychosis and/or suicidality.

Study Overview

• Status: Completed
• Conditions: Psychosis; Suicidal
• Intervention / Treatment: Other: Method of Levels therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • GMMH Park House
  • Manchester, United Kingdom
    • GMMH: Laureate House

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults over the age of 18 years
• Current service user in an acute inpatient ward in the Greater Manchester area
• Capacity to provide informed consent for participating in research
• Good command of English language
• WS1: Experiencing psychosis (this will be screened for using a clinical cut-off score on the CAPE (Mossaheb et al., 2012))
• WS2: Experiencing suicidality (this will be screened for using a cynical cut-off score on the Suicidal Behaviours Questionnaire - revised (SBQ-R) (Osman et al., 2001))

Exclusion Criteria:

• Problems of an organic nature or a learning disability that might affect cognitive functioning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MOL therapy; Participants with Psychosis and/or Suicidality receiving MOL therapy

Other: Method of Levels therapy; MOL therapy aims to help people develop awareness of their personal goals so they can identify incompatibilities and find potential solutions. In MOL, the therapist uses a specific style to help people focus attention on the problem at hand, long enough to consider the issues from different perspectives, including reflection on the associated emotions. This process is usually very experiential and requires the client to be actively engaged in controlling the focus of the session and decision making.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of approved patients recruited	We will deem the study feasible if at least 72% of approached people consent to participate	Study consent meeting, approx. 1 week after initial meeting
Proportion of recruited patients retained	We will deem the study feasible if least 62% of recruited participants are retained (i.e. receive at least one therapy session and complete the end of therapy measures and interview)	End of therapy interview
Number of participants who receiving the intervention	We will deem the study feasible if 10 participants receive at least one therapy session	End of first therapy session, approx. 2 weeks after initial meeting
Acceptability (qualitative)	Qualitative interview with participant at end of therapy analysed using Thematic Analysis	End of therapy interview
Results of Novel Client Measure (descriptive)	Qualitative self-reported perception of what was helpful about the therapeutic environment	End of therapy research meeting
Results of Outcome Rating Scale (descriptive)	Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention	End of therapy research meeting
Feasibility of adaptions required	Qualitative record of adaptions required for use of MOL in an acute inpatient setting	Final follow up meeting with final participant, 3 months after consent

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Outcomes Profile (descriptive)	Outcome measure assessing idiosyncratic problems and distress	End of therapy research meeting
Clinical Outcomes in Routine Evaluation-OM (descriptive)	Outcome measure assessing idiosyncratic problems and distress	End of therapy research meeting
Reorganisation of Conflict Scale (descriptive)	Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL)	End of therapy research meeting
Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent)	Outcome measure assessing experiences of psychosis	End of therapy research meeting
Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent)	Outcome measure assessing experiences of suicidality	End of therapy research meeting

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Sara Tai, DClinPsy, University of Manchester; Principal Investigator: Yvonne Awenat, PhD, University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 8, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 305321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No