Individuals Presenting to Crisis ServicesNCT05484518
Method of Levels for People Using Community Crisis Services
A study testing Method of Levels Therapy in people with Individuals Presenting to Crisis Services, run by University of Manchester at 1 site in United Kingdom.
Trial summary
A mental health crisis is when someone is so distressed they need urgent help from services; often because they behave in ways that poses risk to themselves or others. Crisis teams offer care in the community to support people at home rather than in hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individuals Presenting to Crisis Services
- What is being tested?
- Method of Levels Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Sep 2022to 30 Mar 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, aged over 18 years.
- Meet criteria for crisis services and currently working with the crisis team
- Able to provide informed consent (no queries regarding capacity)
- Willing to engage in psychological therapy.
- Ability to speak English fluently enough to provide informed consent and engage in therapy.
Who cannot join
- Inability to provide informed consent.
- Inability to speak English fluently enough to engage in therapy: As MOL is a therapy that relies on mobilising attention, the use of interpreters during therapy for non-English speakers may serve to alter the participants attention differently. This may confound results; as this is a preliminary case series, it would not be appropriate to include non-English speakers.
- Problems of an organic nature, or a learning disability that might affect cognitive functioning.
- Substance misuse as primary presenting problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Method of Levels (MOL) an Acceptable and Feasible Psychological Intervention for People Using Community Based Crisis Services? A Case Series.
A mental health crisis is when someone is so distressed they need urgent help from services; often because they behave in ways that poses risk to themselves or others. Crisis teams offer care in the community to support people at home rather than in hospital. Current psychological interventions offered by crisis teams tend to be short-term and mainly involve providing information about the difficulties people are experiencing and help them to develop skills, such people as problem solving. This can be useful, however providing more intensive psychological support has been much more difficult within crisis settings, as teams must use limited resources to focus on managing risk. A therapy, called Method of Levels (MOL), designed to be flexible, may be helpful to add to treatment offered by crisis services in the community.
MOL aims to help people hold their attention on a problem long enough to view it in different ways, so that they might think of new solutions. This works by helping a person to regain a sense of control in their life and feel less distressed. MOL is useful for working with lots of different issues, since therapy does not only focus on one type of problem. People also get to choose what is discussed in therapy and session structure.
Research has shown MOL can be useful for people in crisis in places such as inpatient settings. So far, no research has been conducted within the community for people in crisis. This study aims to examine if MOL can be delivered within a crisis service in a way that is helpful and acceptable to people. To do this, the investigators will offer MOL to a small number of people presenting to crisis teams and collect information on whether people take up the therapy, and their experience of receiving it.
- Being tested
- Method of Levels Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of Levels TherapyBehavioural
Method of Levels (MOL) is a therapy that is the direct application of Perceptual Control Theory (PCT) (Powers, 2008) which proposes that psychological distress results from a person's reduced control over important life goals. A conflict between two or more goals can occur outside of a person's awareness (Carey, Mansell \& Tai, 2014) and the achievement of one goal leaves the other incompatible goal unachievable, leading to distress (Mansell, 2012). MOL therapy aims to help people develop awareness of important goals and conflicts between them, to increase their chances of developing potential solutions. Conflict can be resolved through reorganisation; a mechanism through which random change is continuously generated until control is restored (Tai, 2016).
Therapy uses a questioning style to help clients bring their attention to their problems long enough for them to restore control. In practice clients choose the number, frequency and duration of therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Method of Levels Therapy | Experimental | Method of levels therapy, see intervention details. All participants will receive therapy and must attend a minimum of one session for their data to be included in the study. Receives: Behavioral: Method of Levels Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate.
Number of participants recruited into the study.
Measured: Length of study (up to one year)
Retention rate.
Number of participants retained to the end of the study.
Measured: Length of study (up to one year)
Psychological Outcome Profiles.
Quantitative measure to indicate acceptability. Total score between 0-20, where a lower score indicates a better outcome.
Measured: Beginning of each therapy session for length of therapy (chosen by participant), up to 5 months
Session Rating Scale.
Quantitative measure to indicate acceptability.Total score between 0-40, where a lower score indicates a better outcome.
Measured: End of each therapy session (chosen by participant), up to 5 months.
Qualitative interviews
Thematic analysis of qualitative interviews following end of therapy.
Measured: End of therapy, up to 5 months.
Secondary outcomes (4)
Clinical Outcomes in Routine Evaluation Outcome Measure
Questionnaire. Total score between 0-136, where a lower score indicates a better outcome.
Measured: On recruitment, monthly (up to 5 months), one month follow up
Reorganisation of Conflict Scale.
Questionnaire. 22 self reported items, each on a scale of 0-100, where a lower score indicates a better outcome.
Measured: On recruitment, monthly (up to 5 months), one month follow up
Suicidal ideation Attributes Scale.
Questionnaire. Total score of 0-50, where a higher score indicates more severe suicidal thoguhts.
Measured: On recruitment, monthly (up to 5 months), one month follow up
BBC Subjective Well-being scale (BBC-SWB) (Kinderman, Schwannauer, Pontin, & Tai, 2011).
Questionnaire. 24 items scores on a 5 point likert scale, where 5 indiicates high wellbeing.
Measured: On recruitment, monthly (up to 5 months), one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start6 Sep 2022
- Primary completion26 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals Presenting to Crisis ServicesStudies 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
- Case series
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Goodier, University of Manchester
- Investigators
- Sara Goodier, MSc, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484518
- Sponsor's protocol ID
- 316034
- Status last verified
- Dec 2022
- First submitted
- 27 Jul 2022
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Method of Levels (MOL) an Acceptable and Feasible Psychological Intervention for People Using Community Based Crisis Services? A Case Series.
- ClinicalTrials.gov ID
- NCT05484518
- Acronym / sponsor ID
- 316034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 26 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 2 Aug 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.
A mental health crisis is when someone is so distressed they need urgent help from services; often because they behave in ways that poses risk to themselves or others. Crisis teams offer care in the community to support people at home rather than in hospital. Current psychological interventions offered by crisis teams tend to be short-term and mainly involve providing information about the difficulties people are experiencing and help them to develop skills, such people as problem solving. This can be useful, however providing more intensive psychological support has been much more difficult within crisis settings, as teams must use limited resources to focus on managing risk. A therapy, called Method of Levels (MOL), designed to be flexible, may be helpful to add to treatment offered by crisis services in the community.
MOL aims to help people hold their attention on a problem long enough to view it in different ways, so that they might think of new solutions. This works by helping a person to regain a sense of control in their life and feel less distressed. MOL is useful for working with lots of different issues, since therapy does not only focus on one type of problem. People also get to choose what is discussed in therapy and session structure.
Research has shown MOL can be useful for people in crisis in places such as inpatient settings. So far, no research has been conducted within the community for people in crisis. This study aims to examine if MOL can be delivered within a crisis service in a way that is helpful and acceptable to people. To do this, the investigators will offer MOL to a small number of people presenting to crisis teams and collect information on whether people take up the therapy, and their experience of receiving it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series
| Arm | Type | Receives |
|---|---|---|
| Method of Levels Therapy | Experimental | Behavioral: Method of Levels TherapyMethod of levels therapy, see intervention details. All participants will receive therapy and must attend a minimum of one session for their data to be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, aged over 18 years.
- Meet criteria for crisis services and currently working with the crisis team
- Able to provide informed consent (no queries regarding capacity)
- Willing to engage in psychological therapy.
- Ability to speak English fluently enough to provide informed consent and engage in therapy.
Key exclusion criteria (4 listed)
- Inability to provide informed consent.
- Inability to speak English fluently enough to engage in therapy: As MOL is a therapy that relies on mobilising attention, the use of interpreters during therapy for non-English speakers may serve to alter the participants attention differently. This may confound results; as this is a preliminary case series, it would not be appropriate to include non-English speakers.
- Problems of an organic nature, or a learning disability that might affect cognitive functioning.
- Substance misuse as primary presenting problem.
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 TherapyMethod of Levels (MOL) is a therapy that is the direct application of Perceptual Control Theory (PCT) (Powers, 2008) which proposes that psychological distress results from a person's reduced control over important life goals. A conflict between two or more goals can occur outside of a person's awareness (Carey, Mansell \& Tai, 2014) and the achievement of one goal leaves the other incompatible goal unachievable, leading to distress (Mansell, 2012). MOL therapy aims to help people develop awareness of important goals and conflicts between them, to increase their chances of developing potential solutions. Conflict can be resolved through reorganisation; a mechanism through which random change is continuously generated until control is restored (Tai, 2016). Therapy uses a questioning style to help clients bring their attention to their problems long enough for them to restore control. In practice clients choose the number, frequency and duration of therapy sessions | Behavioural | Method of Levels Therapy |
Primary outcome
Recruitment rate.
Time frame: Length of study (up to one year)
Number of participants recruited into the study.
Retention rate.
Time frame: Length of study (up to one year)
Number of participants retained to the end of the study.
Psychological Outcome Profiles.
Time frame: Beginning of each therapy session for length of therapy (chosen by participant), up to 5 months
Quantitative measure to indicate acceptability. Total score between 0-20, where a lower score indicates a better outcome.
Session Rating Scale.
Time frame: End of each therapy session (chosen by participant), up to 5 months.
Quantitative measure to indicate acceptability.Total score between 0-40, where a lower score indicates a better outcome.
Qualitative interviews
Time frame: End of therapy, up to 5 months.
Thematic analysis of qualitative interviews following end of therapy.
4 secondary outcomes
Clinical Outcomes in Routine Evaluation Outcome Measure
Time frame: On recruitment, monthly (up to 5 months), one month follow up
Reorganisation of Conflict Scale.
Time frame: On recruitment, monthly (up to 5 months), one month follow up
Suicidal ideation Attributes Scale.
Time frame: On recruitment, monthly (up to 5 months), one month follow up
BBC Subjective Well-being scale (BBC-SWB) (Kinderman, Schwannauer, Pontin, & Tai, 2011).
Time frame: On recruitment, monthly (up to 5 months), one month follow up
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 10 Dec 2025.
- Individual participant dataSharing planned: No
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 Goodier, MSc principal investigator
University of Manchester
1 site 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 Individuals Presenting to Crisis Services, run by University of Manchester at 1 site 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 5 inclusion and 4 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Recruitment rate. (time frame: Length of study (up to one year)). The study lists 5 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 10 Dec 2025.