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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022577
• Other study ID #: YM108024E
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Medication Adherence
• Motivational Interviewing
• Schizophrenia
• Schizophrenia Spectrum Disorder

Intervention

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).
• control group
The control group received routine care

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).