Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder
Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)
調査の概要
詳細な説明
Major depressive disorder (MDD) is a type of depression that is characterized by a combination of symptoms that can interfere with the ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that individuals of Hispanic descent underutilize specialized mental health care services (SMHS), despite their need for it. In addition, Hispanic individuals have been associated with lower rates of retention in specialized mental health treatment. In particular, dropout rates from medication therapy for the treatment of MDD within SMHS are two to three times higher in Hispanics than in non-Hispanic whites. This study will develop and evaluate the effectiveness of a culturally-based program that aims to facilitate entry, retention, and successful treatment in specialized mental health services for Hispanics with MDD.
This open-label study will consist of four phases. Participants will be recommended for inclusion in the study upon receiving a diagnosis of MDD based on a standard health questionnaire completed in their primary care physician's office. Phase 1 of the study will entail an initial evaluation of the culturally congruent program of care for Hispanics with MDD (CCP-MDD). Participants will be placed in one of two focus groups, each composed of 8 to 10 people. One group will include individuals referred by their primary care physician. The other group will include family members of Hispanics with MDD. Discussions will focus on participants' understandings of depression-like illness, their treatment expectations for these conditions, and their perceived barriers to SMHS utilization. Information gathered in the focus groups will be used to develop a second version of CCP-MDD. Phase 2 of the study will evaluate the revised version of CCP-MDD and will include additional treatments with antidepressant medication, weekly interpersonal psychotherapy, or a combination of the two. Following treatment, participants will take part in a focus group, which will involve participant feedback.
Based on the information obtained in the focus groups and from clinical observations, a third version of CCP-MDD will be developed. In Phase 3, two sets of primary care offices will participate. One set will be assigned to the intervention arm, and receive the third version of the CCP-MDD intervention. A second set will be assigned to the control arm and receive usual referral to mental health services at the research site. All participants will be offered the same choice of treatments: antidepressant medication, weekly interpersonal psychotherapy, or a combination of the two. Treatment in both arms will be of the same duration, 18 wks. Focus groups will be held following treatment in order to obtain information about individuals' satisfaction or dissatisfaction with their care. Based on these findings, as well as clinical observations, a fourth and final version of CCP-MDD will be developed in Phase 4. All treatments will last a total of 18 weeks. A follow-up session will be held at Week 30 to assess depressive symptoms.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
New York
-
New York、New York、アメリカ、10032
- New York State Psychiatric Institute - Hispanic Treatment Program
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
PHASE 1 FOCUS GROUP 1:
- Self-identifies as Hispanic
- Screened positive for MDD during the previous study (WH-PCDP), but was unable to participate in that study due to ongoing depression treatment at the time
- Spanish-speaking
PHASE 1 FOCUS GROUP 2:
- Self-identifies as Hispanic
- Family member of a patient with MDD who participated in the previous study (WH-PCDP)
- Spanish-speaking
PHASES 1-3:
Pre-Engagement Phase
- Self-identifies as Hispanic
- Spanish-speaking
- Positive screen for MDD on the Patient Health Questionnaire (PHQ) and a preliminary diagnosis of MDD from the primary care physician during a standard medical interview
Treatment Phase
- Meets DSM-IV criteria for MDD
- Score of at least 16 on the Hamilton Depression Scale (HAM-D17) at the time of study entry
- Willing to abstain from any other type of specialized mental health services for the duration of the treatment (participants in general health care or participating in folk/spiritual healing practices are expected to continue these during the study)
- Ability to tolerate a drug-free period (2 weeks for most medications; 4 weeks for fluoxetine) if on an ineffective psychotropic medication; if current medication is effective, participants will not be asked to discontinue it (zolpidem for insomnia is also a permitted medication)
- Agrees to use an effective form of contraception for the duration of the study
Exclusion Criteria
PHASE 1 FOCUS GROUP 1:
- Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
- Active suicidal or homicidal ideation that may pose a danger to oneself or others
PHASE 1 FOCUS GROUP 2:
- Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
PHASES 1-3:
Pre-Engagement Phase
- Declines referral by a primary care physician to specialized mental health services
- Comorbid medical or psychiatric conditions that may prevent safe study participation (e.g., substance use disorders, psychosis, unstable medical conditions)
- Active suicidal or homicidal ideation that may pose a danger to oneself or others
Treatment Phase
- History of schizophrenia, bipolar disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndromes
- Clinically unstable medical disease, including glaucoma
- Blood pressure higher than 150/90
- Pregnant or breastfeeding
- Current or past history of seizure disorder (except febrile seizure in childhood)
- Meets DSM-IV criteria for alcohol or substance abuse or dependence (except nicotine) within the 6 months prior to screening
- Use of monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or use of other selective serotonin reuptake inhibitors (SSRIs), antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs, except zolpidem for insomnia within 2 weeks prior to screening
- Currently receiving formal psychotherapy from a mental health provider, whether or not the focus of the therapy is MDD
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Culturally congruent assessment and treatment
Outreach by phone to primary care patients interested in mental health referral.
Engagement and evaluation approach conducted using the DSM-IV cultural formulation model.
Same treatment choices as in control arm (medication, interpersonal psychotherapy, and combination treatment).
|
Referral, engagement, and treatment is done following the cultural formulation model in DSM-IV in which patients' views and expectations about depression treatment are included in the assessment and treatment process.
|
|
アクティブコンパレータ：Usual referral and treatment
Usual referral procedure from primary care: PC clinician gives patient information on how to access mental health care at research site.
Usual engagement and evaluation approach without using cultural formulation model.
Same treatment choices (medication, interpersonal psychotherapy, and combination treatment) as in experimental arm.
|
Referral, engagement, and treatment is done following the cultural formulation model in DSM-IV in which patients' views and expectations about depression treatment are included in the assessment and treatment process.
|
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 |
|---|---|
|
Entry into specialty mental health care from primary care
時間枠：Measured at study completion
|
Measured at study completion
|
|
Entry into treatment for major depressive disorder after evaluation
時間枠：Measured at study completion
|
Measured at study completion
|
|
Dropout from stepped care
時間枠：Measured throughout the study
|
Measured throughout the study
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Score on the Hamilton Depression Scale (17-item)
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Clinical Global Impression Scale
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Working Alliance Inventory
時間枠：Measured at Week 18
|
Measured at Week 18
|
|
Score on the Client Satisfaction Questionnaire
時間枠：Measured at Week 18
|
Measured at Week 18
|
|
Score on the Side Effects Checklist
時間枠：Measured at Week 18
|
Measured at Week 18
|
|
Score on the Quality of Life Index
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Social Adjustment Scale - Self-report version
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Client Satisfaction Questionnaire
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Nervios Treatment Scale
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Working Alliance Inventory
時間枠：Measured at Week 30
|
Measured at Week 30
|
|
Score on the Clinical Global Impression Scale - Patient version
時間枠：Measured at Week 30
|
Measured at Week 30
|
協力者と研究者
捜査官
- 主任研究者：Roberto Lewis-Fernandez, MD、New York State Psychiatric Institute
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
Culturally Congruent Assessment and Treatmentの臨床試験
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)完了