ISTDP for Patients with Treatment Resistance PPS

NCT06682104 | Not Yet Recruiting

• 1 other identifier: KOSMOS3-Individual ISTPD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Somatic Symptom Disorder; Persistent Physical Symptoms; Functional Somatic Syndrome; Functional Somatic Disorder; Medically Unexplained Symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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").

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

Secondary Outcomes (3)

• Patient Health Questionaire-9 (PHQ-9)

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

• Generalized Anxiety Disorder 7-item scale (GAD-7)

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

• Post traumatic symptom Check List-5 (PCL-5)

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

Other Outcomes (4)

• Negative Effects Questionnaire (NEQ)

  At post-treatment (after 16 weeks of treatment)]

• Patient Session rating scale (with 8 additional questions)

  Each week once a week throughout 16 weeks of treatment

• Therapist Rating after each ISTDP session

  Each week once a week throughout 16 weeks of treatment

Study Arms (1)

Individual intensive short term psychodynamic therapy

OTHER

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

Individual intensive short term psychodynamic therapy BEHAVIORAL

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.

Individual intensive short term psychodynamic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Maroti: lead

Study Sites (1)

Stockholm University

Stockholm, Stockholm County, 10691, Sweden

Location

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, principal investigator

Model Details: Open label

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)