Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention

Not Applicable

Completed

• Conditions: Schizophrenia; Psychotic Disorders
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00980252
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

Detailed Description

Overview: Many people recovering from first-episode schizophrenia typically respond very well to their initial course of antipsychotic medications; however, studies indicate that nonadherence rates soar as high as 90% in the first year and do not improve over time. To date, there is no effective psychosocial intervention that improves adherence or reduces the adverse consequences of nonadherence after it occurs. Thus, it is imperative to develop a new intervention to improve medication adherence and improve clinical outcomes in patients recovering from first-episode schizophrenia.

This study is to pilot an intervention specifically suited for patients with first-episode schizophrenia based on the principles of Cognitive Behavioral Therapy (CBT). This is to focus on adherence from the perspective of the patient.

Methods: This study compares the effectiveness of a standard psychoeducation program \[Team Solutions (TS)\] to a CBT approach known as the Health Dialogue Intervention (HDI). Consenting patients will receive a 4 week stabilization assessment period and then be randomized to a prospective, random-assignment study comparing the effectiveness of TS to HDI to improve medication adherence of patients recovering from first-episode schizophrenia.

Study Timeline

• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Study Start: 2009-11
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive Behavioral Therapy	UK-based intervention

Primary Outcome Measures

Name	Time	Method
1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI).	Completion of Study

Secondary Outcome Measures

Name	Time	Method
1. Compare the course of symptoms and relapse of patients in HDI to those in the TS.	Completion of Study

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States