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

Primary Purpose

Motivational Interviewing, Schizophrenia Spectrum Disorder, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Adherence Therapy
control group
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motivational Interviewing focused on measuring Adherence Therapy, Insight, Medication Adherence, Motivational Interviewing, Schizophrenia Spectrum Disorder, Symptom severity, Randomized controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group

control group

Arm Description

The experimental group will participate in a eight session course of Adherence Therapy

The control group received routine care

Outcomes

Primary Outcome Measures

Medication Adherence Rating Scale, MARS
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 Outcome Measures

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.
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 thougThe 30-item 7point Likert scale (from 1-'Absent' to 7-'Extremely').
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.

Full Information

First Posted
July 10, 2019
Last Updated
April 6, 2020
Sponsor
National Yang Ming University
Collaborators
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04022577
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivational Interviewing, Schizophrenia Spectrum Disorder, Medication Adherence
Keywords
Adherence Therapy, Insight, Medication Adherence, Motivational Interviewing, Schizophrenia Spectrum Disorder, Symptom severity, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The experimental group will participate in a eight session course of Adherence Therapy
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group received routine care
Intervention Type
Behavioral
Intervention Name(s)
Adherence Therapy
Other Intervention Name(s)
Motivational interviewing
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
control group
Intervention Description
The control group received routine care
Primary Outcome Measure Information:
Title
Medication Adherence Rating Scale, MARS
Description
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.
Time Frame
for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
Secondary Outcome Measure Information:
Title
Schedule for the Assessment of Insight, SAI
Description
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.
Time Frame
for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
Title
Positive and Negative Syndrome Scale, PANSS
Description
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').
Time Frame
for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).
Title
Self-Appraisal of Illness Questionnaire, SAIQ
Description
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.
Time Frame
for two study groups at baseline(T0) and 3-month follow-up (T1) and 6-month follow-up(T2).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Laing Chen, BSN
Organizational Affiliation
Institute of Community Health Care National Yang-Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

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

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