ISTDP for Patients With Treatment Resistance PPS
24 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Stockholm, Svezia, 10691
- Stockholm University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient Health Questionaire-15 (PHQ-15)
Lasso di tempo: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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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.
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Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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Visual Analoge Scales
Lasso di tempo: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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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").
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Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient Health Questionaire-9 (PHQ-9)
Lasso di tempo: Measured before treatment start and post treatment (after 16 weeks of treatment).
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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.
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Measured before treatment start and post treatment (after 16 weeks of treatment).
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Generalized Anxiety Disorder 7-item scale (GAD-7)
Lasso di tempo: Measured before treatment start and post treatment (after 16 weeks of treatment).
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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.
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Measured before treatment start and post treatment (after 16 weeks of treatment).
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Post traumatic symptom Check List-5 (PCL-5)
Lasso di tempo: Measured before treatment start and post treatment (after 16 weeks of treatment).
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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.
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Measured before treatment start and post treatment (after 16 weeks of treatment).
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Negative Effects Questionnaire (NEQ)
Lasso di tempo: At post-treatment (after 16 weeks of treatment)]
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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.
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At post-treatment (after 16 weeks of treatment)]
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Patient Session rating scale (with 8 additional questions)
Lasso di tempo: Each week once a week throughout 16 weeks of treatment
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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).
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Each week once a week throughout 16 weeks of treatment
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Therapist Rating after each ISTDP session
Lasso di tempo: Each week once a week throughout 16 weeks of treatment
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"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.
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Each week once a week throughout 16 weeks of treatment
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Patient Health Questionaire-4 (PHQ-4)
Lasso di tempo: Each week once a week throughout 16 weeks of treatment
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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.
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Each week once a week throughout 16 weeks of treatment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2025
Completamento primario (Effettivo)
31 dicembre 2025
Completamento dello studio (Effettivo)
31 dicembre 2025
Date di iscrizione allo studio
Primo inviato
6 novembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
8 novembre 2024
Primo Inserito (Effettivo)
12 novembre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KOSMOS3-Individual ISTPD
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Participants have not approved this.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .