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

Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Motivational Interviewing; Schizophrenia Spectrum Disorder
• Intervention / Treatment: Behavioral: control group; Behavioral: Adherence Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The experimental group will participate in a eight session course of Adherence Therapy	Behavioral: Adherence Therapy; Motivational interviewing-based AT in this study was based on Chien et al., (2016) and Gray et al., (2010) eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy).; Other Names: Motivational interviewing
Placebo Comparator: control group; The control group received routine care	Behavioral: control group; The control group received routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence Rating Scale	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schedule for the Assessment of Insight, SAI	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.	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	PANSS assessed the severity of psychotic symptoms in terms of three subscales, including positive symptoms (hallucinations,delusional beliefs, and 30-item 7point Likert scale (from 1-'Absent' to 7-'Extremely').	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	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.	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).

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Yan Laing Chen, BSN, Institute of Community Health Care National Yang-Ming University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 13, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Randomized controlled trial; Medication Adherence; Insight; Symptom severity; Schizophrenia Spectrum Disorder; Adherence Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: YM108024E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No