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CompletedNCT06682104Updated Jul 27, 2026

ISTDP for Patients With Treatment Resistance PPS

An interventional study of Individual intensive short term psychodynamic therapy in Somatic Symptom Disorder, Persistent Physical Symptoms and Functional Somatic Syndrome, sponsored by Daniel Maroti. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Daniel Maroti · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Somatic Symptom Disorder
  • Persistent Physical Symptoms
  • Functional Somatic Syndrome
  • Functional Somatic Disorder
  • Medically Unexplained Symptoms
03

In context

Medically Unexplained Symptoms

71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.

This study's enrollment of 25 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.

Browse Medically Unexplained Symptoms studies →

Lead sponsor

Daniel Maroti is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    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.

    Behavioral: Individual intensive short term psychodynamic therapy

Interventions

  • BehavioralIndividual intensive short term psychodynamic therapy

    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.

06

What researchers measure

Primary outcomes

  1. Patient Health Questionaire-15 (PHQ-15)

    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.

    Time frame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)

  2. Visual Analoge Scales

    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").

    Time frame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)

Secondary outcomes

  1. Patient Health Questionaire-9 (PHQ-9)

    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.

    Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).

  2. Generalized Anxiety Disorder 7-item scale (GAD-7)

    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.

    Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).

  3. Post traumatic symptom Check List-5 (PCL-5)

    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.

    Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).

Other outcomes

  1. Negative Effects Questionnaire (NEQ)

    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.

    Time frame: At post-treatment (after 16 weeks of treatment)]

  2. Patient Session rating scale (with 8 additional questions)

    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).

    Time frame: Each week once a week throughout 16 weeks of treatment

  3. Therapist Rating after each ISTDP session

    "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.

    Time frame: Each week once a week throughout 16 weeks of treatment

  4. Patient Health Questionaire-4 (PHQ-4)

    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.

    Time frame: Each week once a week throughout 16 weeks of treatment

07

Study locations

1 site
  • Stockholm University
    Stockholm, 10691, Sweden
08

References and documents

Individual participant data

Plan to share: No — Participants have not approved this.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682104
Lead sponsor
Daniel Maroti
Responsible party
Daniel Maroti (PhD, principal investigator, Stockholm University) — Sponsor-investigator
First posted
Nov 12, 2024
Start date
Feb 1, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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