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

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Medication Adherence; Schizophrenia Spectrum Disorder; Motivational Interviewing

Treatments: Behavioral: control group; Behavioral: Adherence Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04022577

YM108024E

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Adherence Therapy

control group

Placebo Comparator group

Description:

The control group received routine care

Treatment:

Behavioral: control group