- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484518
Method of Levels for People Using Community Crisis Services
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Manchester, United Kingdom, M139PL
- University of Manchester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Method of Levels Therapy
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate.
Time Frame: Length of study (up to one year)
|
Number of participants recruited into the study.
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Length of study (up to one year)
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Retention rate.
Time Frame: Length of study (up to one year)
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Number of participants retained to the end of the study.
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Length of study (up to one year)
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Psychological Outcome Profiles.
Time Frame: Beginning of each therapy session for length of therapy (chosen by participant), up to 5 months
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Quantitative measure to indicate acceptability.
Total score between 0-20, where a lower score indicates a better outcome.
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Beginning of each therapy session for length of therapy (chosen by participant), up to 5 months
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Session Rating Scale.
Time Frame: End of each therapy session (chosen by participant), up to 5 months.
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Quantitative measure to indicate acceptability.Total score between 0-40, where a lower score indicates a better outcome.
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End of each therapy session (chosen by participant), up to 5 months.
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Qualitative interviews
Time Frame: End of therapy, up to 5 months.
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Thematic analysis of qualitative interviews following end of therapy.
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End of therapy, up to 5 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcomes in Routine Evaluation Outcome Measure
Time Frame: On recruitment, monthly (up to 5 months), one month follow up
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Questionnaire.
Total score between 0-136, where a lower score indicates a better outcome.
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On recruitment, monthly (up to 5 months), one month follow up
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Reorganisation of Conflict Scale.
Time Frame: On recruitment, monthly (up to 5 months), one month follow up
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Questionnaire. 22 self reported items, each on a scale of 0-100, where a lower score indicates a better outcome.
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On recruitment, monthly (up to 5 months), one month follow up
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Suicidal ideation Attributes Scale.
Time Frame: On recruitment, monthly (up to 5 months), one month follow up
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Questionnaire.
Total score of 0-50, where a higher score indicates more severe suicidal thoguhts.
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On recruitment, monthly (up to 5 months), one month follow up
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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
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Questionnaire. 24 items scores on a 5 point likert scale, where 5 indiicates high wellbeing.
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On recruitment, monthly (up to 5 months), one month follow up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Goodier, MSc, University of Manchester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 316034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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