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重度の精神疾患患者に対する個別化された介入としての行動介入の認知モデル

2026年9月26日 更新者:Saskia Bollen、Vrije Universiteit Brussel

重度の精神疾患患者に対する個別行動介入としての行動介入認知モデル (CoMBI)

The aim of this clinical study is to investigate whether CoMBI-SMI helps to reduce behavioral problems and psychiatric complaints in Serious Mental Illness (SMI) populations complaints and to reduce the burden on informal caregivers. It will also be examined whether there is an improvement in the quality of life of the participants. Participants are asked to complete two questionnaires. Then the participants receive treatment as is normally given in a clinical department. In particular, the caregivers will be asked to observe the behavior of the participants using a questionnaire and to follow a CoMBI-training to better tailor the treatment to the core needs of the participants. Comparisons will be made within the participant group because measurements take place before and after the procedure.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

In this study, the effectiveness of a treatment protocol for a personalized approach to behavioral problems, based on the core needs of patients based on their specific personality traits will be investigated. Patients will be recruited from clinical departments of (top) specialist mental health care institutions. Both adult (18-64 years old) and older adults (≥ 65 years) patients with SMI will be included in this study. Primary outcome measures are the Neuropsychiatric Inventory-Questionnaire (NPI-Q) and Brief Symptom Inventory (BSI). Secondary outcome measures are the burden of care for the team and the patient's quality of life, measured with the NPI-Q and Mental Health Quality of life (MHQoL-7D), respectively. Furthermore, predictive factors are mapped for the primary and secondary outcome measures. The gathered NPI-Q data will then be used for a validation study, where the construct validity, internal consistency and inter-rater reliability of the NPI-Q in an SMI population will be assessed.

Individual or group psychotherapy for SMI is not always possible because several patients are unwilling or unable to accept such treatment. Mediation therapy is an alternative, in which interventions are used via a team of professionals to bring about behavioral change in the patient. Unfortunately, there are only a few guidelines and protocols available in the field of mediation therapy. Therefore, the aim of this study will be the development of CoMBI-SMI for the SMI-population. CoMBI-SMI is a combination of cognitive behavioral therapy based upon Beck's cognitive model of personality disorders and nursing interventions from the Nursing Interventions Classification. Triggers from the environment may create a behavioral problem that is maintained by its consequences. The behavioral problems are first identified by the team. Based on this analysis, a core need is selected from the CoMBI-SMI protocol and the associated nursing interventions are selected. This is described in a CoMBI-plan and evaluated cyclically.

Healthcare providers of the departments will be trained in CoMBI-SMI. The training will consist of an online theoretical part about the model followed by a Meet-The-Expert meeting (MTE), where healthcare providers can ask questions about the theoretical part and where CoMBI-SMI will be practiced on the basis of case studies. Quality criteria are linked to the online training, wherein the theoretical part is tested by means of case studies.

According to a stepped wedge design cross-overtime from condition A to CoMBI-SMI varies across participating teams. Condition A is treatment as usual (TAU) with measurements each 4 weeks and the effect is measured by the NPI-Q, BSI and the MHQoL-7D. To properly identify the core needs for the CoMBI-SMI approach, the personality questionnaires Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 (PID-5-Brief form+Modified) and the Level of Personality Functioning-scale brief 2.0 (LPFS-Brief form 2.0) will be used. Then, the CoMBI training takes place and CoMBI-SMI is performed with also measurements each 4 weeks and the effect is measured with the same outcome measures.

研究の種類

介入

入学 (実際)

94

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

    • Limburg
      • Heerlen、Limburg、オランダ、6229ED
        • Mondriaan

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:

  • psychogeriatric inpatients aged 18+
  • presence of SMI and behavioral problems
  • willingness and ability to participate in this study.

Exclusion Criteria:

  • behavioral problems caused by delirium
  • current substance-related disorder
  • treatment in forensic psychiatry at the time of study
  • manic phase
  • florid psychosis
  • when the behavioral problems arise directly from acquired brain injury.

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: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:People with Serious Mental Illness

The target groups are adult (18 to 65 years) and elderly (over 65 years) patients with a Serious Mental Illness. Inclusion criteria: presence of SMI and behavioral problems, willingness and ability to participate in this research.

The first step is analysis of the behavioral problem because the core need is insufficiently compensated by the current environment or counteracted by the behavior of people within that environment. Step 2 is to choose the right core need based on this analysis. CoMBI-SMI describes the patient's self-image, the image of others, the triggering events and the problematic behavior of the patient based on personality disorders as classified by the Diagnostical and Statistical Manual of Mental Disorders. Step 3 is to choose the nursing intervention that is easily deployable so that Healthcare providers can identify the underlying core need and reduce the behavioral problems and burden on the healthcare providers. The fourth and final step is to draw up a CoMBI plan. The CoMBI-SMI is a cyclical process where it is important that the entire team is aligned with the patient's behavioral approach. Interventions are carried out by the entire team and evaluated after an agreed period of time.

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
Neuropsychiatric Inventory - Questionnaire (NPI-Q)
時間枠:Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The NPI-Q was developed and validated in 2000 and translated into Dutch in 2002. The NPI-Q contains 12 domains that can be used to map neuropsychiatric symptoms. These domains are: delusions; hallucinations; agitation/aggression; depression/dysphoria; fear; euphoria / elation; apathy/indifference; disinhibited behavior; irritability/lability; aimless repetitive behavior; night restlessness/sleep disorder; appetite/eating behavior change. The questionnaire is completed by the patient's caregiver and charts whether a particular symptom is present or not, how severe this symptom is (on a three-point scale) if present, and how severe the emotional burden of this symptom is for the caregiver (on a six-point scale). The test-retest correlation of the NPI-Q for symptom severity is 0.80 and for emotional burden is 0.94. The convergent validity, compared to the NPI, is 0.91 for symptom severity and 0.92 for emotional burden.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training
Brief Symptom Inventory (BSI)
時間枠:Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The Brief Symptom Inventory (BSI) is a multidimensional complaints list that shows the extent to which the patient suffered from psychological and/or physical symptoms during the past period. This test also gives a score for the total number of complaints, the total symptoms present and the severity of the symptoms present. The test consists of 53 items scored from "not at all = 0" to "very much = 4". There are 9 subscales: Somatic complaints; Cognitive problems; Interpersonal sensitivity; Depressed mood; Fear; Hostility; Phobic fear; Paranoid thoughts; Psychoticism. The test is sensitive to therapy influences. The BSI is a sufficiently reliable and valid test. The test is standardized for the Dutch language area with the norm groups men vs. women and general population vs. patients. The currently available norm groups were established in 2011.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

二次結果の測定

結果測定
メジャーの説明
時間枠
Mental Health Quality of Life (MHQoL-7D)
時間枠:Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The Mental Health Quality of Life (MHQoL-7D) measures the quality of life in people with mental health problems. The MHQoL-7D is a standardized instrument consisting of two parts: a descriptive section, the MHQoL-7D, and a visual analog scale. The MHQoL-7D consists of seven questions covering seven dimensions, each with four response levels ranging from very satisfied to very dissatisfied: self-esteem, independence, mood, relationships, daily activities, physical health, and future. The total score can range from 0 to 21; the higher the score, the better the quality of life. The MHQoL visual analog scale measures the respondent's general psychological well-being on a horizontal scale ranging from zero, 'only imaginable psychological well-being' to ten, 'best imaginable psychological well-being'.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

その他の成果指標

結果測定
メジャーの説明
時間枠
Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 (PID-5-BF+Modified)
時間枠:Once before the start of the CoMBI-SMI training.

The Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 is a 220-item self-report list of five domains (Negative Affectivity, Detachment, Antagonism, Disinhibition and Psychoticism) and the 25 associated facets of Criterion B measured from the Alternative Personality Disorder Model. The instrument can be used as a reliable screening measure for dimensional maladaptive personality traits. From the longer version PID-5-dutch version it is possible to use the shorter version, the PID-5-Brief form+Modified. The proposed study uses the shortened self-report version and informant version of the derived Dutch version, the PID-5-Brief form+Modified. This version consists of 36 self-report items (all part of the original PID-5) and covers a combination of the five Diagnostic and Statistical Manual of Mental disorders edition 5 domains and the Internation Classification of diseases edition 11 personality trait domain Anankastic, resulting in six domains.

Once before the start of the CoMBI-SMI training.
Level of Personality Functioning-scale brief form 2.0
時間枠:Once before the start of the CoMBI-SMI training.

The LPFS-brief form 2.0 measures the level of personality functioning as described in the Diagnostic and Statistical Manual of mental Disorders with items for the four domains of personality functioning (identity, self-direction, empathy and intimacy) (Rossi et al., 2019). There are three items for each of the four domains, resulting in 12 items.The items measure the four domains of Criterion A to determine the severity of the personality disorder. It is a self-report questionnaire originally developed in Dutch. There is also an informant version. A preliminary study in a clinical sample including younger adults found evidence for a factor structure of two overarching factors, self and interpersonal functioning, that showed relevant associations with different severity measures. In addition, the LPFS-Brief form 2.0 has been shown to have good convergent validity in older adults in a clinical sample.

Once before the start of the CoMBI-SMI training.

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。

スポンサー

捜査官

  • 主任研究者:Saskia Bollen、Vrije Universiteit Brussel

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

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 (実際)

2023年4月28日

一次修了 (実際)

2024年3月1日

研究の完了 (実際)

2024年3月26日

試験登録日

最初に提出

2023年4月7日

QC基準を満たした最初の提出物

2023年4月7日

最初の投稿 (実際)

2023年4月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月26日

最終確認日

2023年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CoMBI-SMI

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いいえ

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