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Search / Trial NCT06682104

ISTDP for Patients with Treatment Resistance PPS

Launched by DANIEL MAROTI · Nov 8, 2024

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a type of therapy called Intensive Short-Term Psychodynamic Psychotherapy (ISTDP) for patients who have persistent physical symptoms (PPS) that haven’t improved with standard treatments. These symptoms can include chronic pain, fatigue, or digestive issues that may have emotional causes. The goal of ISTDP is to help patients understand and express their feelings, like anger or sadness, which may be linked to their physical problems. By doing this, the therapy aims to reduce the severity of these symptoms and improve overall emotional well-being.

To be eligible for the trial, participants should be between the ages of 65 and 74, have experienced moderate distress from their physical symptoms, and be open to exploring emotional factors that may be contributing to their condition. It’s important that participants have already undergone a medical evaluation for their symptoms and have stable medications for at least a month. However, individuals with severe mental health issues or ongoing substance abuse, as well as those who need further medical evaluation for their symptoms, won’t be able to participate. If you join this trial, you can expect a focused therapy experience aimed at helping you gain emotional insight and potentially relieve your physical symptoms in a supportive setting.

Gender

ALL

Eligibility criteria

  • 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.

About Daniel Maroti

Daniel Maroti is a distinguished clinical trial sponsor with a commitment to advancing medical research and innovation. With a robust background in clinical development and regulatory affairs, he specializes in orchestrating trials that adhere to the highest standards of ethics and scientific rigor. His leadership is characterized by a focus on patient safety and data integrity, ensuring that each study contributes meaningfully to the development of new therapies. Through strategic partnerships and a collaborative approach, Daniel Maroti aims to accelerate the translation of groundbreaking research into effective clinical solutions, ultimately enhancing patient outcomes and public health.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported