Acceptability and Feasibility of MOL in Acute Inpatient Units

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377294
• Other study ID #: 305321
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 1, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders
• Suicidal

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	GMMH Park House	Manchester
United Kingdom	GMMH: Laureate House	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
Other	Psychological Outcomes Profile (descriptive)	Outcome measure assessing idiosyncratic problems and distress	End of therapy research meeting
Other	Clinical Outcomes in Routine Evaluation-OM (descriptive)	Outcome measure assessing idiosyncratic problems and distress	End of therapy research meeting
Other	Reorganisation of Conflict Scale (descriptive)	Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL)	End of therapy research meeting
Other	Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent)	Outcome measure assessing experiences of psychosis	End of therapy research meeting
Other	Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent)	Outcome measure assessing experiences of suicidality	End of therapy research meeting
Primary	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
Primary	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
Primary	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
Primary	Acceptability (qualitative)	Qualitative interview with participant at end of therapy analysed using Thematic Analysis	End of therapy interview
Primary	Results of Novel Client Measure (descriptive)	Qualitative self-reported perception of what was helpful about the therapeutic environment	End of therapy research meeting
Primary	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
Primary	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