An Ecological Momentary Intervention for the Reduction of Impairment in Somatic Symptom Disorder

NCT07646509 | Recruiting

• 1 other identifier: SoMI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Somatic Symptom Disorder (DSM-5); Impairment; Psychological Factors; Persistent Physical Symptoms; Medically Unexplained Symptoms

Keywords

Ecological Momentary Intervention; Persistent Somatic Symptoms; Daily Life; Music; Cognitive reappraisal; Somatic Symptom disorder

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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)

  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).

  T0: directly after an event of acute impairment due to somatic symptoms. T1: 20 minutes after T0

Secondary Outcomes (5)

• Change in somatic symptom severity measured with the Patient Health Questionnaire-15

  pre (before week 1) to post (after week 6)

• Change in symptom-related distress measured with the Somatic Symptom Disorder-B Criteria Scale

  Pre (before week 1) -Post (after week 6)

• Change in perceived stress measured with the Perceived Stress Scale 10

  pre (before week 1) - post (after week 6)

• Change of expectations regarding intensity of somatic symptoms

  fixed measurement points morning - day - evening

• Change of expectations regarding impairment due to somatic symptoms

  fixed measurement time points morning - day - evening

Other Outcomes (6)

• Change in the illness perception measured with the Brief Illness Perception Questionnaire

  pre (before week 1) - post (after week 6)

• Change in Emotion regulation measured with the Emotion Regulation Questionnaire

  pre (before week 1) - post (after week 6)

• Change in somatic symptom amplification measured with the Somatosensory Amplification Scale

  pre (before week 1) - post (after week 6)

Study Arms (1)

Music listening/Cognitive reappraisal vs. no intervention

EXPERIMENTAL

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

Interventions

Cognitive reappraisal BEHAVIORAL

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.

Music listening/Cognitive reappraisal vs. no intervention

No intervention BEHAVIORAL

Participants continue with their previous task, but without music listening

Music listening/Cognitive reappraisal vs. no intervention

Music listening BEHAVIORAL

Participants listen to self-selected happy music based on Feneberg et al. (2021). The duration is 10 minutes.

Music listening/Cognitive reappraisal vs. no intervention

Eligibility Criteria

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

You may qualify if:

• Somatic Symptom Disorder

You may not qualify if:

• chronic physical illnesses that fully explain the somatic symptoms
• current psychotic disorder
• current bipolar disorder
• current self-harming behavior
• current suicidality
• current psychotherapy
• alcohol, drug, or medication dependence within the past 6 months

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

University of Vienna

Vienna, State of Vienna, 1010, Austria

RECRUITING

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Related Links

• Leiner, D. J. (2024). SoSci Survey (Version 3.5.02) \[Computer software\]. Available at https://www.soscisurvey.de

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricarda Nater-Mewes, Prof.

  University of Klagenfurt

  PRINCIPAL INVESTIGATOR

• Urs M. Nater, Prof.

  University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricarda Nater-Mewes, Prof.

CONTACT

+43 463 2700 1604; ricarda.nater-mewes@univie.ac.at

Urs M. Nater, Prof.

CONTACT

+43-1-4277-47220; urs.nater@univie.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intra-Individually randomized design: Participants will be randomly assigned (25:25:50) to either one of the intervention condition (music, cognitive reappraisal) or the control condition

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 12, 2026
• Study Start: June 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

AU (1)