Clinical Research Directory

Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

This is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The study population is the patient with somatic symptom disorder. The primary outcomes are somatic distress and health anxiety.

App-Based Self-Management for Somatic Symptom Disorder and MUS: A Pilot Study

Objectives The primary objective of this study is to evaluate the effectiveness of an eight-week self-management mobile application for adults experiencing somatic symptom disorder (SSD) or medically unexplained symptoms (MUS). Improvement will be assessed using the PHQ-15. The secondary objective is to examine changes in clinical symptoms and physiological indicators following app use, as well as to assess the acceptability and usability of the intervention. Scientific Rationale Somatic symptoms without clear medical explanation account for 15-30% of primary care visits (Peveler et al., 1997; Fink et al., 1999; Ko et al., 2011). Diagnostic terminology has evolved from somatoform disorders in DSM-IV and MUS to SSD in DSM-5, which emphasizes distressing symptoms accompanied by maladaptive thoughts, emotions, or behaviors (Scott et al., 2022). SSD is frequently associated with alexithymia, emotional suppression, and difficulty regulating anger, consistent with theories of somatization as the bodily expression of unprocessed affect (Anuk \& Bahadir, 2017; Liu et al., 2011). These difficulties contribute to interpersonal impairment and excessive health care use, often resulting in frustration for clinicians (Orzechowska et al., 2020). Psychological treatments, including CBT, MBSR, MBCT, and ACT, have demonstrated efficacy in reducing symptom burden across conditions such as IBS, fibromyalgia, tinnitus, and chronic fatigue (Hauge et al., 2015; Kikuchi et al., 2020; Roland et al., 2015). These therapies share mechanisms such as enhancing mind-body awareness, reducing physiological hyperarousal, and promoting adaptive coping and acceptance (Aktas et al., 2019; Jing et al., 2019). However, barriers to dissemination remain, as patients with SSD often reject psychological explanations, engage in medical shopping, and maintain strong somatic attributions (Brown, 2007; Harris et al., 2009). Digital interventions offer a scalable solution by providing psychoeducation on mind-body connections, CBT- and mindfulness-based strategies, stress management tools, and behavioral monitoring in an accessible, daily-life format. Evidence suggests that internet- and app-based CBT programs can improve somatic distress and related outcomes, while also reducing treatment costs and improving adherence (Van et al., 2022). Physiological measures such as heart rate variability (HRV) provide an objective biomarker of stress regulation. Lower HRV reflects reduced resilience and greater emotional dysregulation, while higher HRV indicates excessive arousal or impaired recovery. Despite theoretical links between autonomic regulation and somatization, few studies have examined HRV responses in SSD populations alongside psychological interventions. This study addresses that gap. Study Design A randomized controlled trial will recruit 110 adults aged ≥19 years who report significant somatic distress. After screening and informed consent, participants will be randomly assigned (1:1) to intervention (n=55) or control (n=55) using an R-generated allocation table managed independently of investigators. Baseline assessments include standardized questionnaires and HRV measurement. The intervention group will use the mobile application for eight weeks, while the control group will continue treatment as usual. After eight weeks, both groups will complete follow-up questionnaires and HRV measurement. Subsequently, the intervention group will discontinue app use, and the control group will be offered app access. An additional follow-up survey will be conducted online for both groups at 16 weeks. Expected Impact This study will provide empirical evidence on the efficacy, usability, and acceptability of a digital intervention for SSD and MUS. By integrating self-management strategies with physiological monitoring, it aims to advance scalable, evidence-based approaches for a population that has historically been difficult to treat within traditional medical models.

Developing an Integrated Psychotherapy With Cognitive-behavioral Therapy and Biofeedback Therapy for Somatic Symptom Disorder

This research program is aimed to develop a integrative psychotherapy (including CBT and biofeedback therapy) and to examine its efficacy on treatment of somatic symptom disorder. The study design is a randomized controlled trial with waiting list control. Scores of Patient Health Questionniare-15 and Health Anxiety Questionnaire are the primary endpoints.

Treatment of SSD With tcVNS and taVNS

This study aims to compare two non-invasive nerve stimulation devices, gammaCore and Nurosym, to find out which one is more effective in reducing physical discomfort and health-related anxiety in patients with Somatic Symptom Disorder, a condition where individuals experience significant physical symptoms and have excessive thoughts and worries about their health. Participants in this study will receive treatment using both devices at different times. Both devices work by sending mild electrical pulses through the skin to stimulate the vagus nerve, a major nerve that helps regulate body functions. One device (gammaCore) is placed on the neck, while the other (Nurosym) is worn on the ear. The order in which a participant receives the two treatments will be decided by chance, like flipping a coin. Each treatment period will last for two weeks, with a one-week break in between. Over the course of the study (about 8 weeks), participants will visit the hospital for treatment sessions and to complete questionnaires and have non-invasive measurements of body responses, such as heart rate variability.

Alexithymia and Attachment Style in Patients With Somatic Symptoms

To evaluate whether emotional awareness, attachment style and the ability to abstract and symbolize (IQ) influence the appearance of somatic symptoms. Hypothesis: the investigators expect the presence of somatic symptoms linked to the lower ability of emotional awareness, to lower ability to abstract and symbolize and to an insecure attachment style.

Study of Dextromethorphan in OCD and Related Disorders

The purpose of the study is to assess the tolerability and efficacy of dextromethorphan in combination with fluoxetine for symptom relief in OCD and related disorders.

ISTDP for Patients with Treatment Resistance PPS

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.

Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study

Delivering Emotional Awareness and Expression Therapy (EAET) through digital or telehealth platforms in a group format offers several key advantages. First, it significantly improves access to care, allowing individuals with persistent physical symptoms (PPS) to receive effective, emotion-focused therapy regardless of their geographic location. Telehealth can also benefit those who face mobility issues or have limited access to specialized care in rural or underserved areas. Group-based telehealth EAET promotes social connection among participants, fostering a supportive environment where individuals can share experiences, which may enhance therapeutic outcomes. Additionally, the convenience of remote therapy can reduce barriers to participation, such as time constraints and travel costs, making it easier for patients to commit to treatment. Finally, the digital format allows for flexible, scalable interventions that can be easily integrated into routine psychiatric care, potentially increasing treatment uptake for individuals who might otherwise avoid in-person therapy due to stigma or logistical challenges.

Does the First Interview Matter: A Comparing Life Stress Interview Versus a Standard Psychiatric Intake Interview for Patients With Functional Somatic Disorder

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned. Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT). The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms and high health care consumption. The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created. The research question for this specific study is: Can a therapeutic interview (so-called "EAET life-stress interview") focusing on emotional factors in comparison to a psychiatric interview (so-called "basic assessment") contribute to increased interest in psychological treatment and reduction of physical and psychiatric symptoms in patients with medically unexplained symptoms with relatively high health care consumption? Does the order of interview interventions matter?

MR-spectroscopy in Post-covid Condition Prior to and Following a Yoga Breathing Intervention

From a clinical perspective, we find that many patients with Post COVID condition suffer from severe and debilitating shortness of breath, while routine pulmonary investigations fail to find the cause of the problems experienced. If dyspnea is associated with palpitations, dizziness or anxiety, patients are commonly diagnosed with "dysfunctional breathing". From a psychosomatic perspective, the symptom of dysfunctional breathing can be classified as a "functional symptom" under the umbrella term of somatic symptom disorder. Therefore, Yoga interventions with special emphasis on breath-guided relaxation are a promising approach. We aim to investigate the psycho-somatic and somato-psychic pathophysiology on a morphological, psychological, functional and biological basis underlying the symptom of dysfunctional breathing. Furthermore, we plan to investigate the mechanism of Yoga intervention on the mental and somatic symptom burden of participants with Post COVID condition. Then, we aim to compare the impact of Yoga on other groups - healthy individuals, patients with chronic obstructive lung disease (COPD), as well as those with somatic symptom disorder. As a control intervention to Yoga guided breathing exercises a social contact group will be used.