PsychosisNCT04038112
Method of Level (MOL) Therapy for Psychosis
A study testing psychological therapy Method of Levels (MOL) in people with Psychosis, run by University of Manchester.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psychosis
- What is being tested?
- psychological therapy Method of Levels (MOL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Case Series of Method of Levels (MOL) Therapy for People Experiencing Psychosis
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- psychological therapy Method of Levels (MOL)
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological therapy Method of Levels (MOL)Other
Transdiagnostic, cognitive psychological therapy Method of Levels (MOL)
| Study group | Role | What they receive |
|---|---|---|
| Method of Levels (MOL) | Other | all participants will be offered intervention Receives: Other: psychological therapy Method of Levels (MOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- systematic case replication series
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jadwiga Nazimek, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038112
- Sponsor's protocol ID
- 257300
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series of Method of Levels (MOL) Therapy for People Experiencing Psychosis
- ClinicalTrials.gov ID
- NCT04038112
- Acronym / sponsor ID
- 257300
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- systematic case replication series
| Arm | Type | Receives |
|---|---|---|
| Method of Levels (MOL) | Other | Other: psychological therapy Method of Levels (MOL)all participants will be offered intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychological therapy Method of Levels (MOL)Transdiagnostic, cognitive psychological therapy Method of Levels (MOL) | Other | Method of Levels (MOL) |
Primary outcome
Community Assessment of Psychic Experiences (CAPE)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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
Time frame: 12 weeks
Self-administered visual analogue scale, measure of wellbeing. Scores range from 0 to 40, with higher scores indicating higher level of wellbeing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing psychological therapy Method of Levels (MOL) in people with Psychosis, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Assessment of Psychic Experiences (CAPE) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019; AzTrials last refreshed its copy on 2 Nov 2026.