Condition category
Mental and Behavioural Disorders
Date applied
12/09/2016
Date assigned
12/09/2016
Last edited
12/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psychosis is a broad term that refers to experiences such as hearing and seeing things that others cannot, or holding beliefs that others find strange or difficult to understand. Psychosis typically emerges in adolescence and early adulthood. If left untreated, psychosis is extremely distressing for individuals, leading to profound negative effects on an individual’s psychological health, social networks, quality of life and social functioning. In addition, the economic costs to society of untreated psychosis are substantial. Method of Levels (MOL) is a type of talking therapy which is based on the theory that people experience mental distress when they lose control. People can experience a loss of control for several reasons, but one common reason is having conflicting goals. MOL helps people become aware of this conflict by talking through problems, helping people to resolve goal conflict and regain control. The aim of this study is to find out whether MOL is an effective therapy for people experiencing a first episode of psychosis and to find out whether a larger study looking at this is possible by looking at the number of participants who take part.

Who can participate?
Patients aged 16-65 under the care of Greater Manchester West Mental Health NHS Foundation Trust Early Intervention Services for their first episode of psychosis.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive their usual care from their Early Intervention team. Those in the second group receive MOL in addition to their usual care. This involves being able to take part in as many MOL sessions as they like over a 10 month period, in which they talk about their problems with a psychologist trained in MOL therapy. At the start of the study and then again after 10 and 14 months, participants complete a number of questionnaires about the problems participants are experiencing and how they are feeling about themselves. In addition, the number of participants recruited to take part and the number who remained in the trial until the end are recorded to find out whether conducting a larger trial would be possible.

What are the possible benefits and risks of participating?
There are no definite benefits of taking part in this study. However, participants might benefit from access to the Method of Levels therapy sessions. Participants might also benefit from having their mental health and level of risk assessed over a period of time. There are no notable risks involved with participating in this study

Where is the study run from?
Three Early Intervention Teams in the Greater Manchester West Mental Health NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2016 to May 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Robert Griffiths
robert.griffiths@gmw.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Robert Griffiths

ORCID ID

http://orcid.org/0000-0002-5960-914X

Contact details

Psychosis Research Unit
Rico House
George Street
Salford
M25 9WS
United Kingdom
+44 161 358 1395
robert.griffiths@gmw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31862

Study information

Scientific title

Next Level: Evaluating the feasibility and acceptability of Method of Levels therapy for people experiencing a first episode of psychosis

Acronym

Study hypothesis

Research questions:
1. Is Method of Levels (MOL) an acceptable psychological intervention for people experiencing a first episode of psychosis?
2. Is it feasible to deliver MOL to people experiencing a first episode of psychosis who are using early intervention services?
3. Are adaptations necessary to overcome problems or barriers to the implementation of MOL in early intervention services?

Ethics approval

Greater Manchester Central Research Ethics Committee, 17/08/2016, ref: 16/NW/0592

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders

Intervention

Participants will be randomly allocated to either treatment as usual (TAU) or TAU plus Method of Levels (MOL) therapy. The online Sealed Envelope programme will be used to randomise participants to one of the two groups.

TAU group: Participants will continue to receive their usual care from their Early Intervention team.

TAU plus MOL group: Participants will be able to access as many sessions of Method of Levels therapy as they require during a 10 month treatment window, in addition to their usual care from the Early Intervention team. MOL sessions generally last between 15-60 minutes, but the exact length of sessions is decided by the client. Method of Levels (MOL) is a psychological therapy based on Perceptual Control Theory (PCT). PCT proposes that people experience psychological distress when they lose control. People can experience a loss of control for several reasons, but one common reason is having conflicting goals. MOL helps people become aware of this conflict, enabling people to resolve goal conflict and regain control. To do this, MOL therapists ask people to talk about their problems. The therapist then uses questions to help the client become aware of background thoughts that might be relevant to the problem. Through this process of talking about problems and noticing background thoughts, the client becomes aware of their conflicted goals and is able to resolve them. Therapy will be delivered face-to-face by a psychological therapist who has been trained in the delivery of Method of Levels therapy. The therapist will receive ongoing clinical supervision on the use of this approach.

Participants will be asked to complete questionnaires to assess their mental state at a baseline meeting and then 10 and 14 months later.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment rate is measured using the number of participants consenting to participate in the trial at baseline
2. Retention rate is measured using the number of participants retained in the triil at 14 month follow up

Secondary outcome measures

1. Subjective well-being, symptoms, functioning and risk are measured using the CORE-OM at baseline, 10 months and 14 months
2. The problems troubling participants most are measured using the Psychological Outcome Profiles (PSYCHLOPS) at baseline, 10 months and 14 months
3. Reorganisation of goal conflict is measured using the Reorganisation of Conflict Scale (ROC) at baseline, each therapy session, 10 months and 14 months
4. Personal recovery from psychosis is measured using the Questionnaire about the Process of Recovery (QPR) at baseline, 10 months and 14 months
5. Individual, social, relational, and overall functioning are measured using the Outcome Rating Scale (ORS) at baseline, each therapy session, 10 months and 14 months
6. Participant’s perceptions of the therapeutic alliance are measured using the Session Rating Scale (SRS) at each therapy session

Overall trial start date

01/05/2016

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. People aged 16-65 years
2. Current user of Greater Manchester West Mental Health NHS Foundation Trust Early Intervention Services (assessed as experiencing a first episode of psychosis)
3. Sufficient English language abilities (verbal and written) to complete written material (for example, outcome measures) and participate in psychological therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 36; UK Sample Size: 36

Participant exclusion criteria

1. People aged under 16
2. Not currently using of Greater Manchester West Mental Health NHS Foundation Trust Early Intervention Services.
3. Literacy or English language difficulties that make it difficult for the person to complete written material (for example, outcome measures) or to participate in psychological therapy
4. GMW Early Intervention service users who are currently serving a custodial prison

Recruitment start date

01/09/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bolton Early Intervention Team
Bentley House Viking Works Weston Street
Bolton
BL3 2RX
United Kingdom

Trial participating centre

Salford Early Intervention Team
Broadwalk Centre 51 Belvedere Road
Salford
M6 5EJ
United Kingdom

Trial participating centre

Trafford Early Intervention Team
Crossgate House Cross Street
Sale
M33 7FT
United Kingdom

Sponsor information

Organisation

The University of Manchester

Sponsor details

Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The intention is to publish the study findings in peer reviewed journals in 2018/19. Findings will also be presented at relevant conferences. A plain English summary of the study will be produced to provide feedback to participants.

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes