PsychosisNCT05377294
Acceptability and Feasibility of MOL in Acute Inpatient Units
A study testing Method of Levels therapy in people with Psychosis and Suicidal, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Method of Levels therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Aug 2022to 1 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- Problems of an organic nature or a learning disability that might affect cognitive functioning
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GMMH Park House
Manchester
GMMH: Laureate House
Manchester
About this study
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.
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.
- Being tested
- Method of Levels therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of Levels therapyOther
MOL therapy aims to help people develop awareness of their personal goals so they can identify incompatibilities and find potential solutions. In MOL, the therapist uses a specific style to help people focus attention on the problem at hand, long enough to consider the issues from different perspectives, including reflection on the associated emotions. This process is usually very experiential and requires the client to be actively engaged in controlling the focus of the session and decision making.
| Study group | Role | What they receive |
|---|---|---|
| MOL therapy | Experimental | Participants with Psychosis and/or Suicidality receiving MOL therapy Receives: Other: Method of Levels therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of approved patients recruited
We will deem the study feasible if at least 72% of approached people consent to participate
Measured: Study consent meeting, approx. 1 week after initial meeting
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)
Measured: End of therapy interview
Number of participants who receiving the intervention
We will deem the study feasible if 10 participants receive at least one therapy session
Measured: End of first therapy session, approx. 2 weeks after initial meeting
Acceptability (qualitative)
Qualitative interview with participant at end of therapy analysed using Thematic Analysis
Measured: End of therapy interview
Results of Novel Client Measure (descriptive)
Qualitative self-reported perception of what was helpful about the therapeutic environment
Measured: End of therapy research meeting
Results of Outcome Rating Scale (descriptive)
Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention
Measured: End of therapy research meeting
Feasibility of adaptions required
Qualitative record of adaptions required for use of MOL in an acute inpatient setting
Measured: Final follow up meeting with final participant, 3 months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 Aug 2022
- Primary completion30 Jan 2023
- Study completion1 Feb 2023
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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Carr, University of Manchester
- Investigators
- Sara Tai, DClinPsy, Principal investigator, University of ManchesterYvonne Awenat, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377294
- Sponsor's protocol ID
- 305321
- Status last verified
- May 2023
- First submitted
- 8 May 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05377294
- Acronym / sponsor ID
- 305321
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 May 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOL therapy | Experimental | Other: Method of Levels therapyParticipants with Psychosis and/or Suicidality receiving MOL therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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))
Key exclusion criteria (1 listed)
- Problems of an organic nature or a learning disability that might affect cognitive functioning
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 |
|---|---|---|
| Method of Levels therapyMOL therapy aims to help people develop awareness of their personal goals so they can identify incompatibilities and find potential solutions. In MOL, the therapist uses a specific style to help people focus attention on the problem at hand, long enough to consider the issues from different perspectives, including reflection on the associated emotions. This process is usually very experiential and requires the client to be actively engaged in controlling the focus of the session and decision making. | Other | MOL therapy |
Primary outcome
Proportion of approved patients recruited
Time frame: Study consent meeting, approx. 1 week after initial meeting
We will deem the study feasible if at least 72% of approached people consent to participate
Proportion of recruited patients retained
Time frame: End of therapy interview
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)
Number of participants who receiving the intervention
Time frame: End of first therapy session, approx. 2 weeks after initial meeting
We will deem the study feasible if 10 participants receive at least one therapy session
Acceptability (qualitative)
Time frame: End of therapy interview
Qualitative interview with participant at end of therapy analysed using Thematic Analysis
Results of Novel Client Measure (descriptive)
Time frame: End of therapy research meeting
Qualitative self-reported perception of what was helpful about the therapeutic environment
Results of Outcome Rating Scale (descriptive)
Time frame: End of therapy research meeting
Qualitative self-report measure assessing areas of life functioning known to change as a result of therapeutic intervention
Feasibility of adaptions required
Time frame: Final follow up meeting with final participant, 3 months after consent
Qualitative record of adaptions required for use of MOL in an acute inpatient setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sara Tai, DClinPsy principal investigator
University of Manchester
Yvonne Awenat, PhD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of Levels therapy in people with Psychosis and Suicidal, run by University of Manchester at 2 sites in United Kingdom.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of approved patients recruited (time frame: Study consent meeting, approx. 1 week after initial meeting). The study lists 7 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 15 May 2023.