Piloting MOL Intervention for Neuroleptic Decision Making
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|ClinicalTrials.gov Identifier: NCT03537040|
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychosis Medication Adherence||Other: Method of Levels||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Method of Levels
Talking therapy- duration and frequency of sessions to be determined by participant
Other: Method of Levels
- Number of participants recruited to the study [ Time Frame: through study completion, an average of 5 months. ]Number of participants recruited to the study
- Number of participants retained during the study [ Time Frame: through study completion, an average of 5 months. ]Number of participants retained during the study
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Lancashire Care NHS Foundation Trust|
|Preston, Lancashire, United Kingdom, BB10 4el|
|Greater Manchester Mental Health NHS Foundation Trust|
|Manchester, United Kingdom|
|Principal Investigator:||Sara Tai||University of Manchester|