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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05377294
Other study ID # 305321
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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