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 Symptom Disorder
chronic physical illnesses that fully explain the somatic symptoms
current psychotic disorder
current bipolar disorder
current self-harming behavior
Single group
Music listening
BehavioralParticipants listen to self-selected happy music based on Feneberg et al. (2021). The duration is 10 minutes.
Cognitive reappraisal
BehavioralParticipants 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.
No intervention
BehavioralParticipants 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.
Change in short-term impairment due to somatic symptoms
Impairment due to somatic symptoms (visual analog scale, 0-100, higher scores indicate greater impairment).
Change in short-term intensity of somatic symptoms
Intensity due to somatic symptoms (visual analog scale, 0-100; higher scores indicate greater intensity)
Change in short-term severity of negative psychological factors
Negative psychological factors (5-point Likert scale).
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.
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.
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.
Change of expectations regarding intensity of somatic symptoms
Expectations regarding future somatic symptom intensity (visual analog scale; 0-100)
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.
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
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.
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.
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