Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder

Overview

This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.

Full Title of Study: “Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 30, 2019

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 three times: before and after the intervention and 6 months after the intervention ends. 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 IBM SPSS 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.

Interventions

  • Behavioral: Adherence Therapy
    • Motivational interviewing-based AT in this study was based on Gray et al.’s eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy).
  • Behavioral: control group
    • The control group received routine care

Arms, Groups and Cohorts

  • Experimental: experimental group
    • The experimental group will participate in a eight session course of Adherence Therapy
  • Placebo Comparator: control group
    • The control group received routine care

Clinical Trial Outcome Measures

Primary Measures

  • Medication Adherence Rating Scale, MARS
    • Time Frame: for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
    • The MARS was developed by Thompson, Kulkarni, & Sergejew(2000) by combining the Morisky Medication Adherence Questionnaire and the Drug Attitude Inventory. 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 Measures

  • Schedule for the Assessment of Insight, SAI
    • Time Frame: for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
    • The Schedule of Assessment of Insight (SAI) measures multiple dimensions of insight, including compliance with treatment, recognition of illness, re-labeling of psychotic phenomena, and awareness of changes in mental functioning and psychosocial consequences of the illness.The maximum score of the SAI is 14, with higher SAI scores indicating greater insight. The Cronbach alpha for the SAI was 0.96, and inter-rater reliability (r) between the two research psychiatrists was .92 in the present study.
  • Positive and Negative Syndrome Scale, PANSS
    • Time Frame: for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
    • PANSS assessed the severity of psychotic symptoms in terms of three subscales, including positive symptoms (hallucinations,delusional beliefs, and thougThe 30-item 7point Likert scale (from 1-’Absent’ to 7-’Extremely’).
  • Self-Appraisal of Illness Questionnaire, SAIQ
    • Time Frame: for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
    • The Self-Appraisal of Illness Questionnaire (SAIQ) was used to assess patients’ insight into their illness.The need for treatment and presence/outcome of illness subscales of SAIQ have been used as brief screening instruments for schizophrenic patients who may be at risk for treatment noncompliance. Lower SAIQ subscale scores indicate reduced awareness of the psychiatric illness. This scale is a self reporting instrument composed of 17 items in which participants are asked to rate the extent to which they agreed with each statement by using a 4-point Likert scale ranging from 0 (ie, “do not agree at all”) to 3 (ie, “agree completely”). The internal consistency of the scale was 0.867, and the retest reliability was 0.82.

Participating in This Clinical Trial

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 .

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Yang Ming University
  • Collaborator
    • Taipei Veterans General Hospital, Taiwan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yan Laing Chen, BSN, Study Chair, Institute of Community Health Care National Yang-Ming University

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