Back to resultsAcceptability and Feasibility of MOL in Acute Inpatient Units
Primary Purpose
Psychosis, Suicidal
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Method of Levels therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
Eligibility Criteria
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
Sites / Locations
- GMMH Park House
- GMMH: Laureate House
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MOL therapy
Arm Description
Participants with Psychosis and/or Suicidality receiving MOL therapy
Outcomes
Primary Outcome Measures
Proportion of approved patients recruited
We will deem the study feasible if at least 72% of approached people consent to participate
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)
Number of participants who receiving the intervention
We will deem the study feasible if 10 participants receive at least one therapy session
Acceptability (qualitative)
Qualitative interview with participant at end of therapy analysed using Thematic Analysis
Results of Novel Client Measure (descriptive)
Qualitative self-reported perception of what was helpful about the therapeutic environment
Results of Outcome Rating Scale (descriptive)
Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention
Feasibility of adaptions required
Qualitative record of adaptions required for use of MOL in an acute inpatient setting
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05377294
Brief Title
Acceptability and Feasibility of MOL in Acute Inpatient Units
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Suicidal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOL therapy
Arm Type
Experimental
Arm Description
Participants with Psychosis and/or Suicidality receiving MOL therapy
Intervention Type
Other
Intervention Name(s)
Method of Levels therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of approved patients recruited
Description
We will deem the study feasible if at least 72% of approached people consent to participate
Time Frame
Study consent meeting, approx. 1 week after initial meeting
Title
Proportion of recruited patients retained
Description
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)
Time Frame
End of therapy interview
Title
Number of participants who receiving the intervention
Description
We will deem the study feasible if 10 participants receive at least one therapy session
Time Frame
End of first therapy session, approx. 2 weeks after initial meeting
Title
Acceptability (qualitative)
Description
Qualitative interview with participant at end of therapy analysed using Thematic Analysis
Time Frame
End of therapy interview
Title
Results of Novel Client Measure (descriptive)
Description
Qualitative self-reported perception of what was helpful about the therapeutic environment
Time Frame
End of therapy research meeting
Title
Results of Outcome Rating Scale (descriptive)
Description
Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention
Time Frame
End of therapy research meeting
Title
Feasibility of adaptions required
Description
Qualitative record of adaptions required for use of MOL in an acute inpatient setting
Time Frame
Final follow up meeting with final participant, 3 months after consent
Other Pre-specified Outcome Measures:
Title
Psychological Outcomes Profile (descriptive)
Description
Outcome measure assessing idiosyncratic problems and distress
Time Frame
End of therapy research meeting
Title
Clinical Outcomes in Routine Evaluation-OM (descriptive)
Description
Outcome measure assessing idiosyncratic problems and distress
Time Frame
End of therapy research meeting
Title
Reorganisation of Conflict Scale (descriptive)
Description
Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL)
Time Frame
End of therapy research meeting
Title
Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent)
Description
Outcome measure assessing experiences of psychosis
Time Frame
End of therapy research meeting
Title
Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent)
Description
Outcome measure assessing experiences of suicidality
Time Frame
End of therapy research meeting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Tai, DClinPsy
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yvonne Awenat, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
GMMH Park House
City
Manchester
Country
United Kingdom
Facility Name
GMMH: Laureate House
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acceptability and Feasibility of MOL in Acute Inpatient Units
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