NCT04038112

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 24, 2019

Last Update Submit

July 26, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 weeks

  • 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.

    12 weeks

  • 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.

    12 weeks

Study Arms (1)

Method of Levels (MOL)

OTHER

all participants will be offered intervention

Other: psychological therapy Method of Levels (MOL)

Interventions

Transdiagnostic, cognitive psychological therapy Method of Levels (MOL)

Method of Levels (MOL)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: systematic case replication series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology Trainee

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 30, 2019

Study Start

August 1, 2019

Primary Completion

January 31, 2020

Study Completion

March 31, 2020

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share