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Completed

NCT Number: NCT05377294

Acceptability and Feasibility of MOL in Acute Inpatient Units

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Suicidal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GMMH Park House, Manchester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of approved patients recruited

    Time frame: Study consent meeting, approx. 1 week after initial meeting

    We will deem the study feasible if at least 72% of approached people consent to participate

  2. Proportion of recruited patients retained

    Time frame: End of therapy interview

    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)

  3. Number of participants who receiving the intervention

    Time frame: End of first therapy session, approx. 2 weeks after initial meeting

    We will deem the study feasible if 10 participants receive at least one therapy session

  4. Acceptability (qualitative)

    Time frame: End of therapy interview

    Qualitative interview with participant at end of therapy analysed using Thematic Analysis

  5. Results of Novel Client Measure (descriptive)

    Time frame: End of therapy research meeting

    Qualitative self-reported perception of what was helpful about the therapeutic environment

  6. Results of Outcome Rating Scale (descriptive)

    Time frame: End of therapy research meeting

    Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention

  7. Feasibility of adaptions required

    Time frame: Final follow up meeting with final participant, 3 months after consent

    Qualitative record of adaptions required for use of MOL in an acute inpatient setting

Other outcomes

  1. Psychological Outcomes Profile (descriptive)

    Time frame: End of therapy research meeting

    Outcome measure assessing idiosyncratic problems and distress

  2. Clinical Outcomes in Routine Evaluation-OM (descriptive)

    Time frame: End of therapy research meeting

    Outcome measure assessing idiosyncratic problems and distress

  3. Reorganisation of Conflict Scale (descriptive)

    Time frame: End of therapy research meeting

    Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL)

  4. Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent)

    Time frame: End of therapy research meeting

    Outcome measure assessing experiences of psychosis

  5. Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent)

    Time frame: End of therapy research meeting

    Outcome measure assessing experiences of suicidality

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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