Clinical trial NCT04038112: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: systematic case replication series
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Community Assessment of Psychic Experiences (CAPE)
timeFrame: 12 weeks
measure: Reorganization of Conflict Scale (ROC)
timeFrame: 12 weeks
measure: Outcome Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
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