Clinical trial NCT06682104: ISTDP for Patients with Treatment Resistance PPS
Official title: Individual Intensive Short Term Psychodynamic Psychotherapy for Patients with Treatment Resistance Persistent Physical Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Somatic Symptom Disorder
Persistent Physical Symptoms
Functional Somatic Syndrome
Functional Somatic Disorder
Medically Unexplained Symptoms
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient Health Questionaire-15 (PHQ-15)
timeFrame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
measure: Visual Analoge Scales
timeFrame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
Secondary outcomes:
measure: Patient Health Questionaire-9 (PHQ-9)
timeFrame: Measured before treatment start and post treatment (after 16 weeks of treatment).
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Measured before treatment start and post treatment (after 16 weeks of treatment).
measure: Post traumatic symptom Check List-5 (PCL-5)
timeFrame: Measured before treatment start and post treatment (after 16 weeks of treatment).
Other outcomes:
measure: Negative Effects Questionnaire (NEQ)
timeFrame: At post-treatment (after 16 weeks of treatment)]
measure: Patient Session rating scale (with 8 additional questions)
timeFrame: Each week once a week throughout 16 weeks of treatment
measure: Therapist Rating after each ISTDP session
timeFrame: Each week once a week throughout 16 weeks of treatment
measure: Patient Health Questionaire-4 (PHQ-4)
timeFrame: Each week once a week throughout 16 weeks of treatment
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
References: