Acceptability and Feasibility of MOL in Acute Inpatient Units

NCT05377294 | Completed

• 1 other identifier: 305321
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychosis; Suicidal

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Psychological Outcomes Profile (descriptive)

  End of therapy research meeting

• Clinical Outcomes in Routine Evaluation-OM (descriptive)

  End of therapy research meeting

• Reorganisation of Conflict Scale (descriptive)

  End of therapy research meeting

Study Arms (1)

MOL therapy

EXPERIMENTAL

Participants with Psychosis and/or Suicidality receiving MOL therapy

Other: Method of Levels therapy

Interventions

Method of Levels therapy OTHER

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.

MOL therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (2)

GMMH Park House

Manchester, United Kingdom

Location

GMMH: Laureate House

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Sara Tai, DClinPsy

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Yvonne Awenat, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms Lydia Carr, Trainee Clinical Psychologist

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 17, 2022
• Study Start: August 10, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 1, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

GB (2)