Somatic symptom disorder: factors associated with physical complaints

Modifiable factors for somatic symptom persistence in patients with somatic symptom disorder

Registry ID
ISRCTN36251388
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
University Medical Center Hamburg-Eppendorf
Enrollment
240
Start date
2022-04-01
Completion date
2025-09-30
Last update
2026-08-17

Conditions

Summary

Somatic symptom disorder

Detailed description

Macro-level: In the observational cohort study, somatic symptom severity as the primary outcome and a set of relevant predictors will be investigated and assessed at three measurement points during the course of 12 months. After the baseline assessment (T0), two follow-ups will take place at 6 (T2), and 12 months (T3) on the macro level. Depending on the measurement point, patient data will be collected through self-report questionnaires, diagnostical and clinical interviews, physiological exams, medical records, and blood samples. Micro-level: An embedded 12-day smartphone-based study (EMA; ecological momentary assessment) with intermediate status assessments at the first day (T1a) and the last day (T1b) of this period will take place between weeks 2 and 4 after the baseline assessment (T0) on the macro level. Following T1a, ambulatory assessments will start with patients being randomised to one of two groups, receiving either a standard or a positive frame of reference for the assessment of expectations of symptoms (i.e., neutral frame: expectation of symptom severity vs. positive frame: expectation of burden-free periods). During ambulatory assessments, patients will be prompted three times a day for 10 consecutive days to rate their somatic symptom severity, symptom expectations (either neutral frame or positive frame) and treatment experiences. Ambulatory assessments will include self-report questionnaires that will be administered as web-based surveys. These surveys will take place with a customized smartphone application that will be applied to personal smartphones or study-provided smartphones, depending on patients’ preferences, using the software package movisensXS (Movisens GmbH).

Interventions

Inclusion criteria

1. Clinical diagnosis of SSD 2. Sufficient oral and written German language proficiency 3. Provision of written informed consent

Exclusion criteria

1. Acute serious somatic and/or psychological illness requiring immediate intervention 2. Florid psychosis 3. Substance abuse disorder 4. Acute suicidality 5. Severe cognitive impairment affecting self-report questionnaires and interviews

Locations

Related clinical trials

View on source registry