Somatic Symptom DisorderNCT06682104
ISTDP for Patients With Treatment Resistance PPS
A study testing Individual intensive short term psychodynamic therapy in people with Somatic Symptom Disorder and Persistent Physical Symptoms, run by Daniel Maroti at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatic Symptom Disorder, Persistent Physical Symptoms, Functional Somatic Syndrome
- What is being tested?
- Individual intensive short term psychodynamic therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Individual intensive short term psychodynamic therapy
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual intensive short term psychodynamic therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Individual intensive short term psychodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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").
Measured: 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)
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.
Measured: Measured before treatment start and post treatment (after 16 weeks of treatment).
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.
Measured: Measured before treatment start and post treatment (after 16 weeks of treatment).
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.
Measured: Measured before treatment start and post treatment (after 16 weeks of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Maroti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Maroti, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682104
- Sponsor's protocol ID
- KOSMOS3-Individual ISTPD
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants have not approved this.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Intensive Short Term Psychodynamic Psychotherapy for Patients With Treatment Resistance Persistent Physical Symptoms
- ClinicalTrials.gov ID
- NCT06682104
- Acronym / sponsor ID
- KOSMOS3-Individual ISTPD
- Conditions
- Somatic Symptom Disorder, Persistent Physical Symptoms, Functional Somatic Syndrome, Functional Somatic Disorder, Medically Unexplained Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Daniel MarotiUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Individual intensive short term psychodynamic therapy | Other | Behavioral: Individual intensive short term psychodynamic therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual intensive short term psychodynamic therapyISTDP 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. | Behavioural | Individual intensive short term psychodynamic therapy |
Primary outcome
Patient Health Questionaire-15 (PHQ-15)
Time frame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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.
Visual Analoge Scales
Time frame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)
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").
3 secondary outcomes
Patient Health Questionaire-9 (PHQ-9)
Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).
Post traumatic symptom Check List-5 (PCL-5)
Time frame: Measured before treatment start and post treatment (after 16 weeks of treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Participants have not approved this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual intensive short term psychodynamic therapy in people with Somatic Symptom Disorder and Persistent Physical Symptoms, run by Daniel Maroti at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionaire-15 (PHQ-15) (time frame: Lineal regression model using measurement points from from pre-treatment, 1 week before treatment and during treatment (up to 5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.