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
About this trial
This is an interventional treatment trial for Psychosis
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.
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
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
Learn more about this trial
Method of Level (MOL) Therapy for Psychosis
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