Piloting MOL Intervention for Neuroleptic Decision Making

NCT03537040 | Completed

• 1 other identifier: 238098
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the current study is to pilot a novel intervention to help people explore their decision making around the use of neuroleptic medication. A case series design will be used, with outcome variables measured at multiple time points pre-, during- and post-intervention. Participants will also be asked to complete an evaluation interview post-intervention. The primary aim is to investigate the feasibility and acceptability of offering the intervention.

Conditions

Psychosis; Medication Adherence

Outcome Measures

Primary Outcomes (3)

• Number of participants recruited to the study

  Number of participants recruited to the study

  through study completion, an average of 5 months.

• Number of participants retained during the study

  Number of participants retained during the study

  through study completion, an average of 5 months.

• Change in therapeutic alliance from baseline to 12 weeks

  The Session Rating Scale is a brief therapeutic alliance measure designed for every session clinical use. The SRS is a four-item visual analogue instrument that explores the relationship, goals and topics, approach or method, and how the client perceives the session in total. Scores range between 0 and 40, higher scores suggest better therapeutic alliance.

  baseline, 12 weeks.

Secondary Outcomes (5)

• Change in treatment-related empowerment from baseline to 12 weeks

  baseline, 12 weeks.

• Change in attitude towards medication from baseline to 12 weeks

  baseline, 12 weeks.

• Change in compliance to medication regime from baseline to 12 weeks

  baseline, 12 weeks.

• Change in personal recovery from baseline to 12 weeks

  baseline, 12 weeks.

• Change in engagement with services from baseline to 12 weeks

  baseline, 12 weeks.

Study Arms (1)

Method of Levels

OTHER

Talking therapy- duration and frequency of sessions to be determined by participant

Other: Method of Levels

Interventions

Method of Levels OTHER

Talking Therapy

Method of Levels

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 16 years of age
• Capacity to provide informed written consent
• Able to converse in English proficiently
• Currently under the care of an Early Intervention Service or Community Mental Health Team
• Ambivalent around medication use
• Experience of psychosis
• Be able to be assessed in an outpatient facility (exceptions will be made for disabilities)

You may not qualify if:

• If currently experiencing such a deterioration in mental state that they may have difficulties making decisions in their life
• If significant risk of harm to self or others is present
• If there is an organic basis for psychosis

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (2)

Lancashire Care NHS Foundation Trust

Preston, Lancashire, BB10 4el, United Kingdom

Location

Greater Manchester Mental Health NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (2)

• Moncrieff J. Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse. Acta Psychiatr Scand. 2006 Jul;114(1):3-13. doi: 10.1111/j.1600-0447.2006.00787.x.

  PMID: 16774655 BACKGROUND

• Mansell W, Carey TA. A century of psychology and psychotherapy: is an understanding of 'control' the missing link between theory, research, and practice? Psychol Psychother. 2009 Sep;82(Pt 3):337-53. doi: 10.1348/147608309X432526. Epub 2009 Apr 1.

  PMID: 19341533 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sara Tai

  University of Manchester

  PRINCIPAL INVESTIGATOR

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: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 25, 2018
• Study Start: June 27, 2018
• Primary Completion: March 23, 2019
• Study Completion: May 10, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by research team. Requestors will be required to sign a data access agreement

Locations

GB (2)