Feasibility & Acceptability of One-Session MOL Therapy in Primary Care

NCT06063824 | Unknown

• 1 other identifier: 328697
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

People sometimes wait a long time for psychological therapy and could have this sooner if they had only one session. This is because they may only require one session to meet their needs if this is provided quickly (Cannistrà et al., 2020) and may therefore require less therapy overall, and if they can access this, then services can run more efficiently, and overall capacity of services to offer therapy can increase. Some therapies are hard to deliver in one session. But the method of levels (MOL) was conceived to be highly flexible with respect to session length and number of sessions, and this makes it easier to use in one-off sessions. It is designed to help people focus on problems they describe as being most relevant to them and to find their own solutions. We want to know if we can give one session of MOL to people seeking help from their GP. We want to see if they find it helpful. So we need to find out if they want and attend the session and if they tell us about it. This will help us decide whether to run a larger study exploring whether one session of MOL can help meet the goals of people seeking GP support. This could tell us whether MOL could help reduce waiting times. We will ask people using GP surgeries if they want to participate. They will be offered one session of MOL with their usual support. We will ask them to complete questionnaires to see if they found the therapy helpful. We will note how many participate, attend sessions, and complete questionnaires. We will check whether participants liked having MOL and will interview 10-12 of them to learn about what they thought. The research will be funded by The University of Manchester.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes in Routine Evaluation-Outcome Measure

  Up to 3 months

Secondary Outcomes (5)

• Generalised Anxiety Disorder-7

  Up to 3 months

• Patient Health Questionnaire-9

  Up to 3 months

• Psychological Outcome Profiles

  Up to 3 months

• Demographic Questionnaire

  Up to 3 months

• Qualitative Questionnaire

  Up to 3 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Other: Single-Session Method of Levels Intervention

Interventions

Single-Session Method of Levels Intervention OTHER

This is a single session of method of levels psychotherapy delivered to patients of GP surgeries in primary care.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will:
• Be able to speak and read English as a first language
• Be registered at a participating GP surgery and be due to remain at the surgery until the study's completion
• Provide informed consent to participate in the study
• Be 18 years of age or older
• Be able to complete outcome measures
• Score above 10 on an initial core outcome measure
• Express that they are having a difficulty with which they would like help.

You may not qualify if:

• Participants will not:
• Have a mental health difficulty with a confirmed and known organic or neurological foundation
• Be under drug and alcohol services for a substance misuse problem
• Be experiencing active psychosis
• Be under secondary care services for a mental health difficulty
• Express that they have had plans or intentions to end their life or to harm themselves over the month before recruitment
• Express that they have attempted to harm themselves in the month before recruitment
• Express that they have attempted to end their life in the year before recruitment
• Be unable to travel to their GP surgery for their session.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (2)

Wilbraham Surgery

Manchester, Greater Manchester, M21 0UF, United Kingdom

Location

Cornishway Group Practice

Manchester, Greater Manchester, M22 5RX, United Kingdom

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Finbar J Dickinson

CONTACT

07455 532340; finbar.dickinson@postgrad.manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 3, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)