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ISTDP for Patients With Treatment Resistance PPS

2026年7月24日 更新者:Daniel Maroti

Individual Intensive Short Term Psychodynamic Psychotherapy for Patients With Treatment Resistance Persistent Physical Symptoms

Intensive Short-Term Psychodynamic Psychotherapy (ISTDP) for Treatment-Resistant Persistent Physical Symptoms is a therapeutic approach designed to help patients whose physical symptoms have not responded to traditional medical or psychological treatments. These persistent physical symptoms (PPS) often include conditions such as chronic pain, fatigue, or gastrointestinal issues, where a psychological component may be involved.

ISTDP focuses on identifying and addressing unconscious emotional conflicts, which are thought to contribute to or exacerbate physical symptoms. The therapy encourages patients to recognize and express repressed emotions, such as anger, sadness, or fear, which may manifest somatically if left unresolved.

For patients with treatment-resistant PPS, ISTDP offers a focused, time-limited intervention aimed at breaking the cycle of emotional suppression and physical symptomatology. The method involves intense therapeutic engagement, fostering a direct experience of emotions in a controlled environment. Through this process, patients often gain emotional awareness and experience symptom relief.

Research on ISTDP in this population suggests that it can effectively reduce the severity of physical symptoms, improve emotional well-being, and enhance overall functioning when other treatments have not yielded significant results.

For patients with treatment-resistant PPS, ISTDP offers a focused, time-limited intervention aimed at breaking the cycle of emotional suppression and physical symptomatology. The method involves intense therapeutic engagement, fostering a direct experience of emotions in a controlled environment. Through this process, patients often gain emotional awareness and experience symptom relief.

Research on ISTDP for this population suggests that it can be effective in reducing the severity of physical symptoms, improving emotional well-being, and increasing overall functioning when other treatments have failed to produce significant results.

調査の概要

研究の種類

介入

入学 (実際)

25

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

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • The participant certifies that they have undergone a medical evaluation for their physical symptoms.
  • The participant rates either moderate distress from physical symptoms on the PHQ-15 form (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
  • The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
  • Any prescribed medications must have been stable for at least 1 month.
  • Participants must meet the criteria for non-response/treatment resistance, i.e., no reliable change in PHQ-15.

Exclusion Criteria:

  • Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
  • Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
  • Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are allowed as long as the supportive therapy does not occur more than once a month.
  • Participants do not have sufficient proficiency in the Swedish language.
  • Somatic symptoms is judged to be need further medically evaluation or 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: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
他の:Individual intensive short term psychodynamic therapy
The Individual Intensive Short-Term Psychodynamic Psychotherapy (ISTDP) arm for patients with Persistent Physical Symptoms (PPS) focuses on addressing the underlying emotional and psychological factors contributing to these chronic symptoms. In this treatment arm, participants engage in structured, one-on-one psychotherapy sessions with a trained ISTDP therapist.
ISTDP aims to help patients explore and process unconscious emotions, particularly those linked to past trauma or unresolved conflicts, that may be contributing to their physical symptoms. Patients are guided to identify and express repressed feelings such as anger, grief, or fear. The therapist actively engages the patient in a focused and intensive manner, helping them to recognize emotional defenses, break through resistance, and experience these emotions directly in the therapeutic setting.

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
Patient Health Questionaire-15 (PHQ-15)
時間枠:Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
Somatic symptom severity during the "last week" was assessed with the PHQ-15. Items were rated 0 ("Not bothered at all"), 1 ("Bothered a little"), or 2 ("Bothered a lot"); total scores range from 0 to 30 for women and 0-27 for men.
Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
Visual Analoge Scales
時間枠:Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity was measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").
Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient Health Questionaire-9 (PHQ-9)
時間枠:Measured before treatment start and post treatment (after 16 weeks of treatment).
PHQ-9 consists of nine questions withs ratings 0-3 (0= "not at all", 3= "almost every day") on impact of depressive symptoms. Higher scores indicate worse symptom/functioning with a maximum score of 27.
Measured before treatment start and post treatment (after 16 weeks of treatment).
Generalized Anxiety Disorder 7-item scale (GAD-7)
時間枠:Measured before treatment start and post treatment (after 16 weeks of treatment).
GAD-7 consists of seven questions with ratings 0-3 (0= "not at all", 3= "almost every day") on impact of anxiety symptoms. Higher scores indicate worse symptom/functioning functioning with a maximum score of 21.
Measured before treatment start and post treatment (after 16 weeks of treatment).
Post traumatic symptom Check List-5 (PCL-5)
時間枠:Measured before treatment start and post treatment (after 16 weeks of treatment).
PCL-5 consists of 20 questions with ratings 0-4 on impact of post traumatic symptoms. Higher scores indicate worse symptom/functioning with a maximum score of 80.
Measured before treatment start and post treatment (after 16 weeks of treatment).

その他の成果指標

結果測定
メジャーの説明
時間枠
Negative Effects Questionnaire (NEQ)
時間枠:At post-treatment (after 16 weeks of treatment)]
Participants respond to a series of statements regarding potential negative effects they may have experienced during or after therapy, typically using a Likert scale (e.g., 1 = "Not at all," to 5 = "Extremely"). The total score is computed by summing the responses, where higher scores indicate a greater frequency or severity of negative effects.
At post-treatment (after 16 weeks of treatment)]
Patient Session rating scale (with 8 additional questions)
時間枠:Each week once a week throughout 16 weeks of treatment
Session Rating Scale (SRS) evaluates the therapeutic alliance and the quality of the therapy session. It consists of four items rated on a scale from 0 ("Not at all") to 10 ("Extremely") that assess various aspects of the therapy session, including the therapist's understanding of the patient, the relevance of the session, the connection between the patient and therapist, and how well the patient's needs were addressed. In the same manner 8 additional questions on experienced emotions are asked (e.g. on a scale 0-10 how much shame was experienced in the therapy session).
Each week once a week throughout 16 weeks of treatment
Therapist Rating after each ISTDP session
時間枠:Each week once a week throughout 16 weeks of treatment
"Therapist Rating after each ISTDP session" measures several aspects of the therapeutic process and the patient's emotional response during the session. For example, on a five point Likert scale - To a very small extent" to "To a very high extent - the therapist rate the extent to which he/she focused on and/or used typical ISTDP interventions during the session.
Each week once a week throughout 16 weeks of treatment
Patient Health Questionaire-4 (PHQ-4)
時間枠:Each week once a week throughout 16 weeks of treatment
PHQ-4 consists of four questions withs ratings 0-3 (0= "not at all", 3= "almost every day") on impact of depressive symptoms. Higher scores indicate worse symptom/functioning with a maximum score of 12.
Each week once a week throughout 16 weeks of treatment

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

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)

2025年2月1日

一次修了 (実際)

2025年12月31日

研究の完了 (実際)

2025年12月31日

試験登録日

最初に提出

2024年11月6日

QC基準を満たした最初の提出物

2024年11月8日

最初の投稿 (実際)

2024年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月27日

QC基準を満たした最後の更新が送信されました

2026年7月24日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • KOSMOS3-Individual ISTPD

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Participants have not approved this.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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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