An interventional study of Music listening and Cognitive reappraisal in Somatic Symptom Disorder (DSM-5), Impairment and Psychological Factors, sponsored by University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University of Vienna · Not applicable, Interventional, and Treatment
Persistent somatic symptoms significantly impair the daily lives of individuals with Somatic Symptom Disorder (SSD). Negative psychological factors (NPFs), such as catastrophizing and negative affectivity, further compound this impairment. Yet, few studies have examined strategies in daily life that directly target somatic symptoms and their dynamic relationship with NPFs. The goal of this clinical trial is to investigate if an Ecological Momentary Intervention (EMI) using music listening and cognitive reappraisal can reduce the intensity of and impairment due to somatic symptoms in 40 individuals with Somatic Symptom Disorder (SSD), aged 18-65 years.
Participants will report symptom intensity, impairment, and NPFs up to four times daily via a smartphone app over a six-week period. Using an intraindividual randomized controlled design, during weeks two to five, participants will be randomly assigned in the ratio of 50:25:25 to no intervention, music listening, and cognitive reappraisal, both at fixed times (evening measurement) and during episodes of acute somatic impairment.
Somatic symptoms, particularly when medically unexplained, are common stress-related health issues that significantly affect the daily lives of those experiencing them, especially in the more severe form known as Somatic Symptom Disorder (SSD). Specific negative psychological factors (NPFs), such as catastrophizing, negative affectivity, and rumination about somatic symptoms, may contribute to the intensity of and impairment caused by somatic symptoms (Mewes et al., 2022). The intensity and impairment associated with somatic symptoms are crucial outcome variables for both clinicians and those affected, and should therefore be considered in intervention studies (Rief et al., 2017). The best psychological treatment for somatic symptoms is cognitive behavioral therapy with low to moderate effect sizes (van Dessel et al., 2014). Considering the long waiting time for a therapy appointment and the small effect size, other interventions should be considered. Ecological Momentary Interventions (EMIs; Heron \& Smyth, 2010; Mewes, 2022) provide a promising approach for delivering interventions in real time, directly in people's daily lives and their natural environment. By collecting real-time data, EMIs can provide insights into the dynamic relationship between NPFs and somatic symptoms that would otherwise go unnoticed. Because they can address specific events as they occur, EMIs also enable just-in-time interventions in daily life. In addition, real-time assessment of treatment outcomes can contribute to the evaluation of effective interventions. Music listening could be such an intervention. Music listening plays an important role in pain management (Frei \& Szucs, 2025) as listening to music in accordance with the individual music preference has an analgesic effect on pain (Van der Valk Bouman et al., 2024). Music that is perceived as happy predicts the reduction of intensity and impairment caused by somatic symptoms in people with SSD (Feneberg et al., 2021). Thus, music listening seems to be a promising low-threshold intervention in daily life. Another promising approach to reduce somatic symptoms is cognitive reappraisal, since people with SSD show significantly less use of cognitive reappraisal than healthy individuals (Schnabel et al., 2022). When cognitive reappraisal is used as a standalone intervention, it reduces symptom annoyance in individuals with medically unexplained somatic symptoms (Kleinstäuber et al., 2019). Furthermore, when combined with other Cognitive Behavioral Therapy interventions such as stress management, it leads to an improvement in the impairment caused by somatic symptoms (Allen et al., 2006; Visser \& Bouman, 2001). The present study will examine the effects of an EMI in individuals with SSD, employing an intraindividual randomized controlled design with repeated measures. The investigators hypothesize that, from baseline (week 1) to post-intervention (week 6), participants will show a reduction in the weekly average intensity of somatic symptoms, a reduction in impairment due to somatic symptoms, and a reduction in the strength of negative psychological factors (intermediate effect). Furthermore, the investigators hypothesize that, following an acute event, impairment due to somatic symptoms, the intensity of somatic symptoms, and the severity of negative psychological factors will decrease more during an intervention event than during a control event (immediate effects). In addition, the investigators expect a decrease in somatic symptom severity as measured by the Patient Health Questionnaire-15, a decrease in symptom-related distress as measured by the Somatic Symptom Disorder - B Criteria Scale, and a change in perceived stress as measured by the Perceived Stress Scale -10 from pre-intervention (before week 1) to post-intervention (after week 6). Finally, the investigators hypothesize that higher expectations regarding future somatic symptom intensity will be associated with higher somatic symptom intensity at the subsequent assessment, and that higher expectations regarding future somatic symptom impairment will be associated with higher somatic symptom intensity at the subsequent assessment (fixed measurement points throughout the day). Potential participants will be recruited through flyers, online announcements, and potentially newspaper advertisements. The participants will be German-speaking individuals with SSD. Participants will be screened for SSD using a semi-structured interview based on the DSM-5, an operationalization used in a previous study (Mewes et al., 2022). The sample size was calculated using G*Power (Faul et al., 2007) for an F-test in a repeated-measures ANOVA with the within factors. The main outcome is a change in somatic symptoms, with an estimated effect size of f = 0.35 based on Kleinstäuber (2011), and an assumed correlation among repeated measures of 0.3. With a desired power of 0.90, an alpha error of 0.05, one group, two measurement points (average impairment levels baseline vs. post-intervention), and a nonsphericity correction of 1, the required total sample size was 33 participants. To ensure robustness and improve generalizability, and considering a dropout rate of 20%, the aim is to include 40 participants. Potential study participants will either undergo an initial online screening, during which they will be informed about the study and then contacted by us via phone, or proceed directly to a phone screening. During this call, information about the study will be provided, and a semi-structured interview to check for SSD will be conducted (Mewes et al., 2022). Upon receiving verbal consent to participate in the study, an appointment for the distribution of study materials will be arranged. If participants give their verbal consent during the phone screening, they can complete questionnaires, including potential control variables, before the distribution appointment. A link to the pre-questionnaire on SoSci Survey (Leiner, 2024) will be sent via email. If consent is not given during the phone screening, these questionnaires will be completed at the distribution appointment after consent is obtained. At the distribution appointment, the study information will first be discussed with the participants, and written consent to participate in the study will be obtained. Additionally, study materials (either a study smartphone or the installation of an app on the participants' smartphones) and a study manual will be distributed. The EMI begins one day after material distribution. After the post phase of the EMI, participants will again complete questionnaires on SoSci Survey (Leiner, 2024) regarding somatic symptoms. A return date for the materials will be scheduled via email. At the return appointment after the study period, all study materials will be collected. To achieve the research objective, an intraindividual randomized controlled trial will be conducted. An EMI will be conducted, which will be administered using the software MovisensXS. The study consists of three phases spanning a total of 42 days: The baseline phase (7 days), the intervention phase (28 days), and the post phase (7 days). During all three phases, data will be collected three times a day (11 am, 4 pm, and a self-initiated evening assessment). Additionally, in the intervention phase, an additional measurement point occurs 20 minutes after the evening assessment. During all three phases, participants receive prompts through the app at 11 am and 4 pm. The evening assessment can be initiated before going to bed by pressing a button in the app; participants will also receive a reminder at 9 pm. Additionally, participants will be asked to make self-initiated event-based inputs by pressing a button in the app whenever they feel acute somatic symptoms. They will then receive event-related questions immediately and 20 minutes later via a prompt. During the intervention phase, participants will be randomly assigned each day to either an intervention event or a control event. The intervention takes place in the evening and after self-initiated measurements, which are carried out due to impairment caused by somatic symptoms. On any given day, participants will have a 50% chance of receiving no intervention, and a 25% chance of receiving either music listening (Intervention 1) or cognitive reappraisal (Intervention 2). On days allocated to the intervention event, after the evening measurement, participants will engage in a fixed exercise session and receive another prompt 20 minutes after. In the control event, there will be no exercise between the measurement time points. In addition, at the event-based measurements, participants will again be randomly assigned in a 50:25:25 ratio to either continue with their current activity (control condition), engage in music listening (Intervention 1), or perform a cognitive reappraisal task of their somatic symptoms (Intervention 2).
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
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Exclusion Criteria:
Intervention (music listening, cognitive reappraisal) vs. no intervention Every participant will be randomly assigned (25:25:50) to one of the following conditions after they feel more impaired by their somatic symptoms than usual or after the evening measurement: 1. Music listening: listening to self-selected music perceived as happy for 10 minutes (intervention condition) 2. Cognitive reappraisal: (intervention condition) 3. No intervention. Participants continue with their previous task, but without music listening (control condition).
Behavioral: Music listening · Behavioral: Cognitive reappraisal · Behavioral: No intervention
Participants listen to self-selected happy music based on Feneberg et al. (2021). The duration is 10 minutes.
Participants will be asked to write down their thoughts regarding their somatic complaints. They will be asked to consider the complaints from a more positive perspective. Subsequently, participants reread their written complaints. To develop another point of view, participants will be encouraged to apply more helpful thoughts to their somatic symptoms, such as "I feel really bad right now, but I'm certain I do not have a serious illness." (Kleinstäuber et al., 2019) The intervention lasts between 5 - 10 minutes.
Participants continue with their previous task, but without music listening
Change in intermediate Intensity of and impairment by somatic symptoms and in the strength of negative psychological factors
Intensity of somatic symptoms: visual analog scale (0-100; higher scores indicate a greater level of intensity), impairment by somatic symptoms visual analog scale (0-100; higher scores indicate a greater level of impairment), negative psychological factors: 5-point Likert scale; higher levels indicate stronger negative psychological factors.
Time frame: baseline (week 1) to post (week 6)
Change in short-term impairment due to somatic symptoms
Impairment due to somatic symptoms (visual analog scale, 0-100, higher scores indicate greater impairment).
Time frame: T0: directly after an event of acute impairment due to somatic symptoms; T1: 20 minutes after T0
Change in short-term intensity of somatic symptoms
Intensity due to somatic symptoms (visual analog scale, 0-100; higher scores indicate greater intensity)
Time frame: T0: directly after an event of acute impairment due to somatic symptoms; T1: 20 minutes after T0
Change in short-term severity of negative psychological factors
Negative psychological factors (5-point Likert scale).
Time frame: T0: directly after an event of acute impairment due to somatic symptoms. T1: 20 minutes after T0
Change in somatic symptom severity measured with the Patient Health Questionnaire-15
Somatic Symptom Severity (Patient Health Questionnaire-15): Values range from 0-30; Higher scores indicate a greater somatic symptom severity.
Time frame: pre (before week 1) to post (after week 6)
Change in symptom-related distress measured with the Somatic Symptom Disorder-B Criteria Scale
Symptom-related distress: Somatic Symptom Disorder-B Criteria Scale. The values range from 0 to 48. Higher scores indicate more symptom-related distress.
Time frame: Pre (before week 1) -Post (after week 6)
Change in perceived stress measured with the Perceived Stress Scale 10
Perceived stress (Perceived Stress Scale 10). The value ranges from 0 to 40; Higher scores indicate more perceived stress.
Time frame: pre (before week 1) - post (after week 6)
Change of expectations regarding intensity of somatic symptoms
Expectations regarding future somatic symptom intensity (visual analog scale; 0-100)
Time frame: fixed measurement points morning - day - evening
Change of expectations regarding impairment due to somatic symptoms
Expectations regarding future somatic symptom impairment: visual analog scale (0-100)
Time frame: fixed measurement time points morning - day - evening
Change in the illness perception measured with the Brief Illness Perception Questionnaire
Illness perception (Brief Illness Perception Questionnaire). Values range from 0 to 80. Higher scores indicate a worse illness perception.
Time frame: pre (before week 1) - post (after week 6)
Change in Emotion regulation measured with the Emotion Regulation Questionnaire
Emotion Regulation Questionnaire. Values range from 1 to 7 per item. Higher scores in the subscales indicate more use of this strategy
Time frame: pre (before week 1) - post (after week 6)
Change in somatic symptom amplification measured with the Somatosensory Amplification Scale
Somatosensory Amplification Scale (SSAS): Values range from 10 to 50. Higher scores indicate more somatosensory amplification.
Time frame: pre (before week 1) - post (after week 6)
Change in symptom-related disability measured with the Pain Disability Index-adapted
Pain Disability Index-adapted (PDI): Values range from 0 to 70. Higher scores indicate pain is interfering more with daily life.
Time frame: pre (before week 1) - post (after week 6)
Change in the health-related quality of life measured with the Short Form Health Survey 12
Short Form Health Survey-12 (SF-12): Values range from 0 to 100. Higher scores indicate better self-reported health.
Time frame: pre (before week 1) - post (after week 6)
Change in depression measured with the Patient Health Questionnaire-9
Patient Health Questionnaire-9 (PHQ-9): Values range from 0 to 27. Higher scores indicate worse depression symptoms.
Time frame: pre (before week 1) - post (after week 6)
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