Meditation for Depression (CMIT)
Central Meditation and Imagery Therapy for Depression
Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However, currently available treatment options have limited efficacy. The aim of this pilot study is to determine whether patients suffering from MDD who have not responded to at least one antidepressant trial may actively engage in a novel group therapy, Central Meditation and Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT techniques may have benefit for major depression. The purpose of this trial is to assess the feasibility of a group form of CMIT for the treatment of major depression. The trial will also seek to identify neurophysiological and cardiovascular predictors of treatment response.
In this study, 10 subjects with major depressive disorder will receive antidepressant treatment augmentation with group meditation and mental imagery therapy for a total of 12 weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic stretches. The subjects will be limited to those who remain depressed despite at least one trial of antidepressant medication. Changes in brain activity and heart rate variability will be measured at three time points utilizing electroencephalography (EEG) and pulse monitors. Depression symptoms will be measured at several time points using questionnaires and objective measures. Participation will require a total of 15 visits for weekly therapy and the measurements. Two-month follow-up questionnaires will be mailed to the subjects after study end to assess durability of any improvements in depressive symptoms.
調査の概要
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
-
-
California
-
Los Angeles、California、アメリカ、90024
- UCLA Semel Institute
-
-
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:
- Meeting the DSM-IV criteria for unipolar major depressive disorder, as assessed by the Mini-Neuropsychiatric International Interview (MINI).
- HAM-D17 rating scale ≥ 14.
- Prior treatment with antidepressant medication during the present major depressive episode
- Adequate written and oral fluency in English to understand and complete study forms and converse with study personnel.
- Willingness on part of both subject and treating clinician to not change antidepressant treatment, including medications, psychotherapy or other treatments, over the course of the study, unless necessary to provide for well being of subject.
Exclusion Criteria:
- Current diagnosis of schizophrenia or any psychotic disorder including psychotic depression, dysthymia, mania or bipolar disorder, attention deficit or hyperactivity disorder, generalized anxiety disorder or panic disorder, obsessive compulsive disorder, alcohol or drug dependence, mental retardation, any pervasive developmental disorder or cognitive disorder (according to DSM-IV) criteria. Those with lifetime history of psychiatric conditions other than unipolar major depression will be also excluded.
- Medically unstable, delirious, or terminally ill (e.g. medical illness requiring hospitalization or intense outpatient management, such as heart disease; heart attack in the past 6 months; congestive heart failure; severe heart arrythmias; unstable hypertension; poorly controlled diabetes; or pending surgery).
- Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
- Participants regularly practicing (≥ 2 times per week) any of the techniques utilized in the study to reduce stress: meditation, guided imagery, yoga.
- Current treatment with behavior therapy or psychotherapy.
- Active suicidal plan as measured by HAM-D item 3 score of greater than or equal to 3, or history of suicide attempt during the current episode.
- Utilization of cannabis or other illicit drugs more than once a month.
- Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7 standard drinks per week or 3 drinks per day.
- Needing to adjust or change anti-depressant treatment, including medications, psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive Therapy (ECT), or Vagus Nerve Stimulation (VNS).
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：なし
- 介入モデル：単一グループの割り当て
- 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：Central Meditation and Imagery Therapy
Intervention involved Central Meditation, may be characterized by a voluntary, regulated attentional set towards a specific stimulus or set of stimuli and visualization exercises utilized within CMIT, which primarily involves two types of thought experiments: 1) creating mental models of how a person fits into the larger world and universe according to evolutionary biology and modern cosmology, in order to gain a larger perspective on emotions and thought patterns, and 2) backcasting, the generation of a desirable future coupled with mental time travel back to the present to determine how to create that future with present-day actions.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D)
時間枠：Measured 4 times over 12 weeks
|
Primary outcome is change in HAM-D from baseline to Week 12.
|
Measured 4 times over 12 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR)
時間枠：Weekly assessments measured over 12 weeks, and 2 month follow-up
|
Weekly assessments measured over 12 weeks, and 2 month follow-up
|
協力者と研究者
捜査官
- 主任研究者：Felipe Jain, M.D.、University of California, Los Angeles
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 (実際)
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。