(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)
2017年9月18日 更新者：Radboud University Medical Center
(Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.
Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .
Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).
We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.
調査の概要
研究の種類
介入
入学 (実際)
245
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
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Gelderland
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Nijmegen、Gelderland、オランダ、6500HB
- Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
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Utrecht
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Bilthoven、Utrecht、オランダ、3723 MB
- Helen Dowling Institute
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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
18年歳以上 (大人、高齢者)
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
Inclusion Criteria:
- HADS ≥ 11
- Cancer diagnosis (at present or past)
- Stable dose if using psychopharmacological medication for at least 3 months
- computer literacy and acces to internet
- capable of filling out questionnaires in Dutch
Exclusion Criteria:
- severe psychiatric morbidity as psychoses, suicidal ideation
- previous mindfulness-based treatment.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Online MBCT
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This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice.
Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week.
They will receive files with meditation and yoga exercises to support this.
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実験的：group MBCT
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This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice.
Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week.
They will receive files with meditation and yoga exercises to support this.
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介入なし：Treatment as usual
3 months waiting list, subsequent assignment to group or online MBCT
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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 |
|---|---|---|
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Change from baseline in anxiety and depressive symptoms
時間枠：0 (baseline), 3 months (post intervention)
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Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS).
The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms.
The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002).
This instrument was also validated in a palliative cancer population (Akechi, 2006).
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0 (baseline), 3 months (post intervention)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in fear of cancer recurrence
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI; Simard & Savard, 2009a; van der Lee et al., 2012).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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DSM-IV Axis I mood or anxiety disorders
時間枠：0, 3 (post intervention), 12 months (9mo follow-up)
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DSM IV Axis I psychiatric disorder as diagnosed by a structured interview
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0, 3 (post intervention), 12 months (9mo follow-up)
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Change from baseline in positive mental health
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The Mental Health Continuum-Short Form (MHC-SF) measures positive mental health and comprises 14 items, representing various feelings of well-being.
Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day).
The MHC-SF contains three subscales: emotional, psychological and social well-being.
MHC-SF has shown high internal and moderate test-retest reliability, convergent and discriminant validity.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in healthcare consumption
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The TIC-P generates quantitative data about direct medical costs and indirect societal costs as a consequence of psychological/psychiatric illnesses.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in health-related quality of life
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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To measure the quality of the health status of cancer patients a validated health-related quality of life (HRQoL) instrument will be used, the EuroQol-5D (EQ-5D).
This HRQoL instrument will be completed by the patient together with a researcher and is available in a validated Dutch translation (Lamers, 2005).
The EQ-5D is a generic HRQoL instrument comprising five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The EQ-5D index is obtained by applying predetermined weights to the five domains.
This index gives a societal-based global quantification of the participant's health status on a scale ranging from 0 (death) to 1 (perfect health).
Participants will also be asked to rate their overall HRQoL on a visual analogue scale (EQ- 5D VAS) consisting of a vertical line ranging from 0 (worst imaginable health status) to 100 (best imaginable).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in health-related quality of life
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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In addition to the EQ-5D, the SF-12 will be administered for explorative purposes for there are indications that the SF-12 is more sensitive for changes in HRQol in populations with less severe morbidity (Johnson and Coons, 1998).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in mindfulness skills
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The 39-item Five Facet Mindfulness Questionnaire has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness.
A Dutch 24-item short form of the FFMQ (FFMQ-SF) was developed and assessed in a sample of 376 adults with clinically relevant symptoms of depression and anxiety and cross-validated in an independent sample of patients with fibromyalgia.
Confirmatory factor analyses showed good model fit for the five-factor structure of the FFMQ-SF: observing, describing, acting with awareness, nonjudging, and nonreactivity.
The FFMQ-SF was related to measures of psychological symptoms, well-being, experiential avoidance, and the personality factors neuroticism and openness to experience.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in rumination
時間枠：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The rumination subscale of the RRQ assesses a neurotic self-attentiveness (i.e.
recurrent, primarily past-oriented thinking about the self), which is prompted by threats, losses, of injustices to the self.
Subjects rate their level of agreement of disagreement on a five-point rating scale (e.g., "I always seem to be rehashing in my mind recent things I've said or done").
There is evidence of good internal consistency (.90) and stability over a 10-month period and convergent validity.
The measure in the current study was translated into Dutch using the guidelines of the International Test Commission (Hambleton, 1994).
Cronbach's alphas were .88 and .90 in Sample 1, and .90 and .91 in Sample 2, respectively (Luyckx et al., 2008).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in personality assessment
時間枠：0 (baseline) and 12 months (9mo follow-up)
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Personality is measured with the NEO Five Factor Inventory (NEO-FFI, Costa & McCrae, 1992) which consists of five domains: neuroticism, extraversion, openness, altruism, and conscientiousness.
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0 (baseline) and 12 months (9mo follow-up)
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Change in mindfulness skills during intervention
時間枠：week 2,3,4,5,6,7,8 and 9 of intervention
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The Mindful Attention Awareness Scale (MAAS) will be administered before each MBCT session to assess mindful attention in daily life
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week 2,3,4,5,6,7,8 and 9 of intervention
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Group cohesion during intervention
時間枠：week 4 and week 9 during intervention
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We will examine self-reported individual group cohesion ratings during the MBCT training with a Dutch Group Cohesion Questionnaire that has been used in cancer patients before (May et al., 2008).
The GCQ-23 uses 22 items across four scales: the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value.
Each item is rated from 1 (totally disagree) to 6 (totally agree).
Internal consistency of all scales was reported to range from adequate to good (0.66-0.88).
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week 4 and week 9 during intervention
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Working alliance during intervention
時間枠：week 4 and week 9 during intervention
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The Working Alliance Inventory (WAI) is most often used to assess working alliance between participant and healthcare professional.
We will use the Dutch translation of the short form (WAI-S, Vervaeke & Vertommen, 1996), which is closely related to the original scale and also has good psychometric and predictive quality (Busseri & Tyler, 2003).
The WAI-S is a 12 item, self report questionnaire, rated on a 7-point Likert scale (1 = never to 7 = always) with three subscales: 1) agreement between participant and therapist on the goals of the therapy; 2) agreement on the rationale of the therapy addressing the problems of the participant; and 3) the quality of the interpersonal bond between the participant and the therapist.
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week 4 and week 9 during intervention
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Change in mood during intervention
時間枠：week 2,3,4,5,6,7,8 and 9 of intervention
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In the current study, positive and negative affect is assessed before each MBCT session using the International Positive and Negative Affect Scale - Short Form.
The cross-sample stability, internal reliability, temporal stability, crosscultural factorial invariance, and convergent and criterion-related validities of the I-PANAS-SF were examined and found to be psychometrically acceptable (Thompson, 2007).
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week 2,3,4,5,6,7,8 and 9 of intervention
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Change from baseline in anxiety and depressive symptoms - follow up
時間枠：0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
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Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.
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0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
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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：Anne EM Speckens, MD, PhD、Radboud University Medical Centre Nijmegen
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Bisseling EM, Compen FR, Schellekens MPJ, Thewes B, Speckens AEM, van der Lee ML. Exploring Fear of Cancer Recurrence in a Sample of Heterogeneous Distressed Cancer Patients with and Without a Psychiatric Disorder. J Clin Psychol Med Settings. 2021 Sep;28(3):419-426. doi: 10.1007/s10880-021-09776-2. Epub 2021 Jun 17.
- Bisseling E, Cillessen L, Spinhoven P, Schellekens M, Compen F, van der Lee M, Speckens A. Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Med Internet Res. 2019 Oct 18;21(10):e14065. doi: 10.2196/14065.
- Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, Speckens A. Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2018 Aug 10;36(23):2413-2421. doi: 10.1200/JCO.2017.76.5669. Epub 2018 Jun 28.
- Compen FR, Bisseling EM, Van der Lee ML, Adang EM, Donders AR, Speckens AE. Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study. BMC Psychol. 2015 Aug 13;3(1):27. doi: 10.1186/s40359-015-0084-1. eCollection 2015.
便利なリンク
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
2014年4月1日
一次修了 (実際)
2016年7月20日
研究の完了 (実際)
2017年5月1日
試験登録日
最初に提出
2014年5月6日
QC基準を満たした最初の提出物
2014年5月12日
最初の投稿 (見積もり)
2014年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月19日
QC基準を満たした最後の更新が送信されました
2017年9月18日
最終確認日
2016年2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。