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

NCT07646509 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

Music listening

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

BEHAVIORAL

Cognitive reappraisal

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.

BEHAVIORAL

No intervention

Participants continue with their previous task, but without music listening

Sponsors & Collaborators

  • University of Vienna

    lead OTHER

Principal Investigators

  • Ricarda Nater-Mewes, Prof. · University of Klagenfurt

  • Urs M. Nater, Prof. · University of Vienna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646509 on ClinicalTrials.gov