Clinical trial NCT04022577: Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder
Official title: Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Schizophrenia Spectrum Disorder
Medication Adherence
Keywords: Adherence Therapy
Insight
Medication Adherence
Motivational Interviewing
Schizophrenia Spectrum Disorder
Symptom severity
Randomized controlled trial
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2019-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

  1. Non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time
  2. The patient recently (half year) relapse of mental illness
  3. 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 .

Primary outcomes:
measure: Medication Adherence Rating Scale
timeFrame: 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).
Secondary outcomes:
measure: Schedule for the Assessment of Insight, SAI
timeFrame: 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).
measure: Positive and Negative Syndrome Scale, PANSS
timeFrame: 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).
measure: Self-Appraisal of Illness Questionnaire, SAIQ
timeFrame: 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).
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: Institute of Community Health Care National Yang-Ming University
name: Yan Laing Chen, BSN
role: STUDY_CHAIR
References: