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

2014年6月13日 更新者:Peter Weiden、University of Illinois at Chicago
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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

34

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • University of Illinois at Chicago

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

16年~45年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

There is a 2 step inclusion/exclusion criteria, the first being for assessing overall eligibility to enter the study, and then, for continued outpatient treatment for schizophrenia, schizophreniform disorder, or schizoaffective disorder.

Inclusion criteria for entry into the Evaluation Phase:

  1. Between 16-45 years of age
  2. A provisional clinical diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder in last 6 months
  3. Discharge from inpatient unit for treatment of psychotic symptoms must have occurred in the last 6 months, or, if never hospitalized, initial treatment started in the last 6 months
  4. Able to fully participate in the informed consent process
  5. The patient is judged to be an appropriate candidate for ongoing outpatient follow-up at the First-episode Treatment Program at the Psychotic Disorders Program at UIC

Exclusion criteria for the Evaluation Phase:

  1. Unable to understand informed consent process
  2. A history of nonresponse to prior antipsychotic trials such that long-term inpatient treatment or clozapine will be recommended
  3. Prior treatment with clozapine
  4. Discharge from inpatient treatment for psychotic symptoms, initial treatment, or provisional diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform occurred more than 6 months from enrollment into the evaluation phase
  5. Pregnancy or stated goal to become pregnant
  6. Will not be living close enough to the medical center to return for follow-up visits or assessments
  7. History of geographic instability such that it is judged unlikely that patient will reside in the area
  8. Currently under arrest for a felony, or an arrest is deemed likely in the near future
  9. Currently receiving medication over objection by court order
  10. Currently receiving treatment in another research protocol

Inclusion Criteria for the Treatment Intervention Phase:

  1. Willingness to transition to receive evaluation and future pharmacologic treatment at the Psychotic Disorders Program at UIC
  2. Has capacity to understand the risks and benefits of participating in a randomized psychosocial trial
  3. Willingness to sign informed consent to go into the Treatment Intervention Phase
  4. Is able to complete a post-test for understanding the nature of the study and what it entails, and the potential risks and benefits of study participation
  5. Is willing to have therapy sessions recorded for fidelity assessments
  6. Is willing to receive follow-up independent assessments of adherence status, including separate interviews with trained independent raters, and our contacting the outpatient pharmacy for pharmacy refill records

Exclusion criteria for Treatment Intervention Phase:

  1. Diagnosis or inpatient treatment for psychotic symptoms occurred more than 6 months from date of enrollment into evaluation phase
  2. Acutely psychotic individuals may not participate because therapy will not benefit if symptoms are too severe
  3. Has dropped out of the treatment program and cannot be located for follow-up appointments
  4. Stated refusal to come for to at least one clinical evaluation appointment at the PDP, or has been a "no show" for at least three consecutive appointments
  5. Judged to be at significant and imminent risk of harm to self or others*
  6. Ongoing active substance or alcohol use that is not controlled during the Evaluation Phase, along with refusal of referral to a "dual diagnosis" treatment program for substance abuse problems
  7. Remains enrolled in another research protocol at UIC*
  8. Unwilling to consider any additional psychotherapeutic intervention above and beyond coming in to the service for medication management appointment
  9. Baseline PANSS total score ≥ 90, or has a individual PANSS item of conceptual disorganization (item P2), excitement (P4), or hostility (P7) that is ≥ 5 (moderately severe)*
  10. Judged to require additional concrete case management services to support medication adherence*
  11. Receives antipsychotics under coercive conditions (e.g. inpatient or outpatient commitment)*

Note: The exclusion criteria (*) may be present during some parts of the Evaluation Phase and would need to be resolved within the 4 week time period permitted for the Evaluation Phase prior to the Treatment Intervention Phase of study entry.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:CBT
UK-based intervention
Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
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).
時間枠:Completion of Study
Completion of Study

二次結果の測定

結果測定
時間枠
1. Compare the course of symptoms and relapse of patients in HDI to those in the TS.
時間枠:Completion of Study
Completion of Study

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Peter J. Weiden, M.D.、University of Illinois at Chicago

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年11月1日

一次修了 (実際)

2012年12月1日

研究の完了 (実際)

2013年3月1日

試験登録日

最初に提出

2009年9月18日

QC基準を満たした最初の提出物

2009年9月18日

最初の投稿 (見積もり)

2009年9月21日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年6月16日

QC基準を満たした最後の更新が送信されました

2014年6月13日

最終確認日

2014年6月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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