NCT05484518

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

July 27, 2022

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Recruitment rate.

    Number of participants recruited into the study.

    Length of study (up to one year)

  • Retention rate.

    Number of participants retained to the end of the study.

    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.

    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.

    End of each therapy session (chosen by participant), up to 5 months.

  • Qualitative interviews

    Thematic analysis of qualitative interviews following end of therapy.

    End of therapy, up to 5 months.

Secondary Outcomes (4)

  • Clinical Outcomes in Routine Evaluation Outcome Measure

    On recruitment, monthly (up to 5 months), one month follow up

  • Reorganisation of Conflict Scale.

    On recruitment, monthly (up to 5 months), one month follow up

  • Suicidal ideation Attributes Scale.

    On recruitment, monthly (up to 5 months), one month follow up

  • BBC Subjective Well-being scale (BBC-SWB) (Kinderman, Schwannauer, Pontin, & Tai, 2011).

    On recruitment, monthly (up to 5 months), one month follow up

Study Arms (1)

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.

Behavioral: Method of Levels Therapy

Interventions

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

Method of Levels Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M139PL, United Kingdom

Location

Study Officials

  • Sara Goodier, MSc

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
One group only, no masking required.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student/Chief Investigator

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 2, 2022

Study Start

September 6, 2022

Primary Completion

February 26, 2023

Study Completion

March 30, 2023

Last Updated

December 10, 2025

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations