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Piloting MOL Intervention for Neuroleptic Decision Making

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537040
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Rea Dicks, University of Manchester

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.

Condition or disease Intervention/treatment Phase
Psychosis Medication Adherence Other: Method of Levels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Assess the Feasibility and Acceptability of a Novel Intervention to Help People Think About Their Neuroleptic Medication Use.
Actual Study Start Date : June 27, 2018
Actual Primary Completion Date : March 23, 2019
Actual Study Completion Date : May 10, 2019

Arm Intervention/treatment
Method of Levels
Talking therapy- duration and frequency of sessions to be determined by participant
Other: Method of Levels
Talking Therapy




Primary Outcome Measures :
  1. Number of participants recruited to the study [ Time Frame: through study completion, an average of 5 months. ]
    Number of participants recruited to the study

  2. Number of participants retained during the study [ Time Frame: through study completion, an average of 5 months. ]
    Number of participants retained during the study

  3. Change in therapeutic alliance from baseline to 12 weeks [ Time Frame: baseline, 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.


Secondary Outcome Measures :
  1. Change in treatment-related empowerment from baseline to 12 weeks [ Time Frame: baseline, 12 weeks. ]
    The Treatment-related Empowerment Scale assesses the patients perceived degree of involvement within their treatment by assessing components of communication, treatment choice, decisions and satisfaction. The scale consists of 10 items in which respondents rate the extent to which their experience matches each statement on a 5 point Likert scale. High scores represent higher treatment-related empowerment.

  2. Change in attitude towards medication from baseline to 12 weeks [ Time Frame: baseline, 12 weeks. ]
    The Drug Attitude Inventory-10 a 10-item modified version of the Drug Attitude Inventory-30 Questionnaire, commonly used to evaluate medication adherence and captures an individual's general attitude about taking medication. Scores range between -10 and +10, higher scores indicate a more positive attitude towards medication.

  3. Change in compliance to medication regime from baseline to 12 weeks [ Time Frame: baseline, 12 weeks. ]
    Participants will be asked to rate their current compliance using a 4-point scale that was developed for another study (Barrowclough et al., 1999). Scores range from 0-4, higher scores indicate higher compliance.

  4. Change in personal recovery from baseline to 12 weeks [ Time Frame: baseline, 12 weeks. ]
    Questionnaire about the Process of Recovery a 15-item measure used to assess personal recovery. Scores range between 15 and 75, higher scores are indicative of recovery.

  5. Change in engagement with services from baseline to 12 weeks [ Time Frame: baseline, 12 weeks. ]
    The Service Engagement Scale is a 14-item clinician-rated measure that assesses service user engagement with community mental health services. Scores range between 0 and 42, lower scores indicate better engagement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537040


Locations
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United Kingdom
Lancashire Care NHS Foundation Trust
Preston, Lancashire, United Kingdom, BB10 4el
Greater Manchester Mental Health NHS Foundation Trust
Manchester, United Kingdom
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Sara Tai University of Manchester
Publications:
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Responsible Party: Rea Dicks, Trainee Clinical Psychologist, University of Manchester
ClinicalTrials.gov Identifier: NCT03537040    
Other Study ID Numbers: 238098
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Annoymous data files for outcome data will be shared on request
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders