Psychosis Clinical Trial
Official title:
Is Method of Levels (MOL) Therapy an Acceptable and Feasible Psychological Intervention for People in Acute Mental Health Inpatient Services: A Case Series.
NCT number | NCT05377294 |
Other study ID # | 305321 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 10, 2022 |
Est. completion date | February 1, 2023 |
Verified date | May 2023 |
Source | University of Manchester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | February 1, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | GMMH Park House | Manchester | |
United Kingdom | GMMH: Laureate House | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Psychological Outcomes Profile (descriptive) | Outcome measure assessing idiosyncratic problems and distress | End of therapy research meeting | |
Other | Clinical Outcomes in Routine Evaluation-OM (descriptive) | Outcome measure assessing idiosyncratic problems and distress | End of therapy research meeting | |
Other | Reorganisation of Conflict Scale (descriptive) | Outcome measure assessing goal conflict reorganisation (a key mechanism of change in MOL) | End of therapy research meeting | |
Other | Community Assessment of Psychic Experiences (if experiencing psychosis at point of consent) | Outcome measure assessing experiences of psychosis | End of therapy research meeting | |
Other | Linehan Reasons for Living Inventory (if experiencing suicidality at point of consent) | Outcome measure assessing experiences of suicidality | End of therapy research meeting | |
Primary | Proportion of approved patients recruited | We will deem the study feasible if at least 72% of approached people consent to participate | Study consent meeting, approx. 1 week after initial meeting | |
Primary | Proportion of recruited patients retained | 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) | End of therapy interview | |
Primary | Number of participants who receiving the intervention | We will deem the study feasible if 10 participants receive at least one therapy session | End of first therapy session, approx. 2 weeks after initial meeting | |
Primary | Acceptability (qualitative) | Qualitative interview with participant at end of therapy analysed using Thematic Analysis | End of therapy interview | |
Primary | Results of Novel Client Measure (descriptive) | Qualitative self-reported perception of what was helpful about the therapeutic environment | End of therapy research meeting | |
Primary | Results of Outcome Rating Scale (descriptive) | Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention | End of therapy research meeting | |
Primary | Feasibility of adaptions required | Qualitative record of adaptions required for use of MOL in an acute inpatient setting | Final follow up meeting with final participant, 3 months after consent |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04929938 -
Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
|
N/A | |
Recruiting |
NCT05863572 -
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
|
N/A | |
Completed |
NCT04277585 -
Improving Access to Early Psychosis Coordinated Specialty Care
|
N/A | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Not yet recruiting |
NCT05558332 -
Youth Nominated Support Team
|
N/A | |
Not yet recruiting |
NCT05358457 -
Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
|
N/A | |
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Completed |
NCT02895269 -
COllaborative Shared Care to IMprove Psychosis Outcome
|
N/A | |
Recruiting |
NCT02622048 -
Understanding and Helping Families: Parents With Psychosis
|
N/A | |
Completed |
NCT02653729 -
Cbt for Psychosis and Affect on Psychosis Symptoms
|
Phase 2 | |
Completed |
NCT02733575 -
Compassion Focused Therapy for Distressing Experiences
|
N/A | |
Completed |
NCT02531243 -
Computer-Aided Learning for Managing Stress
|
N/A | |
Not yet recruiting |
NCT02244970 -
Mindfulness RCT for Early Psychosis
|
N/A | |
Enrolling by invitation |
NCT01364818 -
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
|
N/A | |
Withdrawn |
NCT00786318 -
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
|
Phase 4 | |
Recruiting |
NCT00722163 -
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
|
Phase 0 |