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

NCT04022577 | Completed DMC

• 1 other identifier: YM108024E
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Motivational Interviewing; Schizophrenia Spectrum Disorder; Medication Adherence

Keywords

Adherence Therapy; Insight; Medication Adherence; Motivational Interviewing; Schizophrenia Spectrum Disorder; Symptom severity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Schedule for the Assessment of Insight, SAI

  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

  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

  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).

Study Arms (2)

experimental group

EXPERIMENTAL

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

Behavioral: Adherence Therapy

control group

PLACEBO COMPARATOR

The control group received routine care

Behavioral: control group

Interventions

Adherence Therapy BEHAVIORAL

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).

Also known as: Motivational interviewing

experimental group

control group BEHAVIORAL

The control group received routine care

control group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

National Yang-Ming University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Motivational Interviewing; Control Groups

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yan Laing Chen, BSN

  Institute of Community Health Care National Yang-Ming University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 17, 2019
• Study Start: October 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 7, 2024

Record last verified: 2023-10

Locations

TW (1)