ISTDP for Patients With Treatment Resistance PPS
24 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
25
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Stockholm, Suécia, 10691
- Stockholm University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Patient Health Questionaire-15 (PHQ-15)
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Patient Health Questionaire-9 (PHQ-9)
Prazo: 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)
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Negative Effects Questionnaire (NEQ)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2025
Conclusão Primária (Real)
31 de dezembro de 2025
Conclusão do estudo (Real)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
6 de novembro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de novembro de 2024
Primeira postagem (Real)
12 de novembro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KOSMOS3-Individual ISTPD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Participants have not approved this.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .