Somatic symptom disorder: factors associated with physical complaints

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN36251388

Enrollment

240

Registered

2022-02-15

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatic symptom disorder Mental and Behavioural Disorders Somatization disorder

Interventions

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 th

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 (

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Macro-level with three measurement points: T0 (baseline), T2 (6 months after T0), T3 (12 months after T0): 1. Patient-reported somatic symptom burden assessed using the sum score of the Patients Health Questionnaire (PHQ-15) at all measurement points on the macro level 2. Patient-reported somatic symptom intensity assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) at all measurement points on the macro level Micro-level with two intermediate measurement points and 30 ambulatory measurement points: intermediate measurement point T1a (2 weeks after T0), ambulatory measurement points (3 times a day on 10 consecutive days after T1a), intermediate measurement point T1b (after ambulatory measurement points) 1. Patient-reported somatic symptom burden assessed using the sum score of the Patients Health Questionnaire (PHQ-15) at the intermediate measurement points T1a and T1b 2. Patient-reported somatic symptom intensity assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) at the intermediate measurement points T1a and T1b 3. Patient-reported somatic symptom burden assessed using the sum score of an adapted version of the Patients Health Questionnaire (PHQadapt) at the ambulatory measurement points	—

Measure

Time frame

Macro-level with three measurement points: T0 (baseline), T2 (6 months after T0), T3 (12 months after T0): 1. Patient-reported somatic symptom burden assessed using the sum score of the Patients Health Questionnaire (PHQ-15) at all measurement points on the macro level 2. Patient-reported somatic symptom intensity assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) at all measurement points on the macro level Micro-level with two intermediate measurement points and 30 ambulatory measurement points: intermediate measurement point T1a (2 weeks after T0), ambulatory measurement points (3 times a day on 10 consecutive days after T1a), intermediate measurement point T1b (after ambulatory measurement points) 1. Patient-reported somatic symptom burden assessed using the sum score of the Patients Health Questionnaire (PHQ-15) at the intermediate measurement points T1a and T1b 2. Patient-reported somatic symptom intensity assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) at the intermediate measurement points T1a and T1b 3. Patient-reported somatic symptom burden assessed using the sum score of an adapted version of the Patients Health Questionnaire (PHQadapt) at the ambulatory measurement points

—

Secondary

Measure	Time frame
Assessed at all three measurement points on the macro level: T0 (baseline), T2 (6 months after T0), T3 (12 months after T0): 1. Overall somatic symptom interference assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) 2. Symptom-related disability assessed using the sum score of the Pain Disability Index – adapted (PDI) 3. Health-related quality of life assessed using the sum score of the Short Form health survey (SF-12) 4. Health care use assessed using the sum score of the Health care Utilization Questionnaire (HCU-Q) 5. Perceived efficacy of health care assessed using the score on an 11-point numeric rating scale (PercE, NRS) 6. Perceived adverse effects of health care assessed using the score on an 11-point numeric rating scale (PercA, NRS)	—

Measure

Time frame

Assessed at all three measurement points on the macro level: T0 (baseline), T2 (6 months after T0), T3 (12 months after T0): 1. Overall somatic symptom interference assessed using the score on an 11-point numeric rating scale (EURONET-SOMA1, NRS) 2. Symptom-related disability assessed using the sum score of the Pain Disability Index – adapted (PDI) 3. Health-related quality of life assessed using the sum score of the Short Form health survey (SF-12) 4. Health care use assessed using the sum score of the Health care Utilization Questionnaire (HCU-Q) 5. Perceived efficacy of health care assessed using the score on an 11-point numeric rating scale (PercE, NRS) 6. Perceived adverse effects of health care assessed using the score on an 11-point numeric rating scale (PercA, NRS)

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026