Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Motivational Interviewing
- Sponsor
- National Yang Ming Chiao Tung University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Medication Adherence Rating Scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.
Detailed Description
A single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern Taiwan. After baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. The experimental group will participate in a eight session course of Adherence Therapy. The control group received routine care. The data will be collected for baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks). A structured Questionnaire will use to collect data on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight, Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the Social Sciences 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.
Investigators
Eligibility Criteria
Inclusion Criteria
- •aged 20-64
- •were Chinese speaking or Taiwanese speaking;
- •diagnosed with schizophrenia or schizoaffective disorder
- •recent history of non-adherence to antipsychotic medication.
- •Non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time
- •The patient recently (half year) relapse of mental illness
- •Family and Health care worker state that the patient has taken irregular medication
- •demonstrated cognitive understanding of the research plan and provided consent.
Exclusion Criteria
- •discharged from hospital for at least 3 months
- •no intellectual disability, organic brain diseases or Cognitive impairment
- •no alcohol or sub-stance abuse problems
- •were not attending medication management program .
Outcomes
Primary Outcomes
Medication Adherence Rating Scale
Time Frame: for two study groups at baseline(T0) and after 4 session interim analysis (T1；9-12 weeks) and 8 session after intervention (T2；21-28 weeks).
The Medication Adherence Rating Scale was developed by Thompson et al. (2000). It evaluates the adherence behavior and attitude of the patient within the previous week. There are 10 close-ended questions (yes/no answers) in the questionnaire.
Secondary Outcomes
- Schedule for the Assessment of Insight, SAI(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)
- Self-Appraisal of Illness Questionnaire, SAIQ(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)
- Positive and Negative Syndrome Scale, PANSS(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)