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Method of Level (MOL) Therapy for Psychosis

Primary Purpose

Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psychological therapy Method of Levels (MOL)
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants have to be registered with a Community Mental Health Services
  • Participants need to either meet ICD-10 criteria for schizophrenia, schizoaffective disorder and delusional disorder or meet entry criteria for an Early Intervention for Psychosis service.

Exclusion Criteria:

  • Known moderate to severe learning disability
  • Known organic basis of symptoms
  • Known lack of capacity to consent to participating in research
  • Lack of fluency in English (since MOL therapy will be conducted in English and due to use of standardised assessment tools). This will be determined by the researcher.
  • Acute inpatient status
  • A primary diagnosis of a drug or alcohol dependency
  • Concurrent psychological therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Method of Levels (MOL)

    Arm Description

    all participants will be offered intervention

    Outcomes

    Primary Outcome Measures

    Community Assessment of Psychic Experiences (CAPE)
    Self-administered questionnaire, measure of symptoms of psychosis and associated distress. Total scores range from 42 to 168 on both dimensions (symptoms and distress). Higher scores indicate higher frequency of symptoms and higher distress.
    Reorganization of Conflict Scale (ROC)
    Self-administered questionnaire measures the degree of reorganization (resolution) of internal conflict. Scores range from 0 to 110, with higher scores indicating higher level of internal conflict resolution.
    Outcome Rating Scale
    Self-administered visual analogue scale, measure of wellbeing. Scores range from 0 to 40, with higher scores indicating higher level of wellbeing.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2019
    Last Updated
    July 26, 2019
    Sponsor
    University of Manchester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04038112
    Brief Title
    Method of Level (MOL) Therapy for Psychosis
    Official Title
    A Case Series of Method of Levels (MOL) Therapy for People Experiencing Psychosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    January 31, 2020 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    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 study is a systematic case replication series of a new psychological therapy Method of Levels (MOL) for people who experience psychosis. Between 6 and 8 people with psychosis who receive services from CMHT will be recruited. Participants will complete baseline questionnaires measuring their symptoms and distress and will be offered up to 12 sessions of MOL. Following the completion of therapy they will complete the questionnaires measuring symptoms and distress again.
    Detailed Description
    Psychosis is an enduring and distressing mental illness which can cause high levels of disability. Recommended treatments include antipsychotic medication and Cognitive Behaviour Therapy (CBT). Antipsychotic drugs cause serious negative side effects which are intolerable for some patients. CBT can be difficult to conduct in the presence of comorbid problems and can be too demanding for some patients. Both medication and CBT sometimes fail to sufficiently reduce the symptoms. Method of Levels (MOL) is a flexible, short-term, cognitive therapy informed by a theory that explains the underpinnings of psychological distress and the mechanisms of action in effective therapy. The purpose of the current study is to evaluate the utility of MOL for individuals with non-affective psychosis who are under the care of secondary mental health services. A case series will explore the efficacy of MOL for the levels of symptoms, distress and general functioning. MOL will be offered to 6-8 individuals with psychosis within a flexible appointment scheduling system. Levels of symptoms, distress and general functioning will be measured before and after treatment. Open feedback interviews following the completion of treatment will allow us to evaluate the patients' experience of MOL. The project will provide preliminary data which will inform clinical practice and contribute to large scale research of MOL.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    systematic case replication series
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Method of Levels (MOL)
    Arm Type
    Other
    Arm Description
    all participants will be offered intervention
    Intervention Type
    Other
    Intervention Name(s)
    psychological therapy Method of Levels (MOL)
    Intervention Description
    Transdiagnostic, cognitive psychological therapy Method of Levels (MOL)
    Primary Outcome Measure Information:
    Title
    Community Assessment of Psychic Experiences (CAPE)
    Description
    Self-administered questionnaire, measure of symptoms of psychosis and associated distress. Total scores range from 42 to 168 on both dimensions (symptoms and distress). Higher scores indicate higher frequency of symptoms and higher distress.
    Time Frame
    12 weeks
    Title
    Reorganization of Conflict Scale (ROC)
    Description
    Self-administered questionnaire measures the degree of reorganization (resolution) of internal conflict. Scores range from 0 to 110, with higher scores indicating higher level of internal conflict resolution.
    Time Frame
    12 weeks
    Title
    Outcome Rating Scale
    Description
    Self-administered visual analogue scale, measure of wellbeing. Scores range from 0 to 40, with higher scores indicating higher level of wellbeing.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants have to be registered with a Community Mental Health Services Participants need to either meet ICD-10 criteria for schizophrenia, schizoaffective disorder and delusional disorder or meet entry criteria for an Early Intervention for Psychosis service. Exclusion Criteria: Known moderate to severe learning disability Known organic basis of symptoms Known lack of capacity to consent to participating in research Lack of fluency in English (since MOL therapy will be conducted in English and due to use of standardised assessment tools). This will be determined by the researcher. Acute inpatient status A primary diagnosis of a drug or alcohol dependency Concurrent psychological therapy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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