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Effectiveness of psychotherapy in patients with medically unexplained physical symptoms

Effectiveness of psychotherapy in patients with medically unexplained physical symptoms: A multi-site naturalistic study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13532466
Enrollment
500
Registered
2018-05-14
Start date
2018-01-26
Completion date
Unknown
Last updated
2022-08-05

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

Conditions

Medically unexplained physical symptoms (MUPS) Signs and Symptoms Medically unexplained physical symptoms (MUPS)

Interventions

Multi-component psychological treatment is provided to all participants on a daily basis. The core of the treatment is group psychotherapy provided with a frequency of 2 to 5 times a week for a period

Sponsors

Faculty of Social Studies, Masaryk University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age of 18 or more years 2. Occurrence of at least one somatic symptom with a duration of at least six months not fully explained by any somatic diagnosis

Exclusion criteria

Exclusion criteria: 1. Diagnosis of a severe mental disorder that would make participation in this kind of treatment impossible 2. Diagnosis of an organic disease responsible for the symptoms Note: All patients willing to participate are included in the study. Primary analysis is conducted on patients with MUPS. Secondary analyses, however, are conducted on the whole sample (i.e., including patients without somatic symptoms and those with somatic symptoms explained by an organic disease).

Design outcomes

Primary

MeasureTime frame
Intensity of medically unexplained physical symptoms is measured using PHQ-15 at the beginning of the treatment, weekly during the treatment, at termination, and 6 and 12 months after termination.

Secondary

MeasureTime frame
SECONDARY OUTCOMES 1. General distress is measured using ORS at the beginning of treatment, weekly during treatment, and at termination. 2. Depression is measured using PHQ-9 at the beginning of treatment, at termination, and 6 and 12 months after termination. 3. Anxiety is measured using GAD-7 at the beginning of treatment, at termination, and 6 and 12 months after termination. 4. Well-being is measured using WHO-5 at the beginning of treatment, at termination, and 6 and 12 months after termination. 5. Role functioning is measured using selected items from PHQ at the beginning of treatment, at termination, and 6 and 12 months after termination. HYPOTHESIZED MEDIATORS OF CHANGE WHICH, THEMSELVES, REPRESENT SECONDARY OUTCOMES 6. Somatic awareness is measured using MAIA at the beginning of treatment, weekly during treatment, and at termination. 7. Emotion regulation skills are measured using ERSQ at the beginning of treatment, weekly during treatment, and at termination. 8. Acceptance of symptoms is measured using CPAQ modified at the beginning of treatment, weekly during treatment, and at termination. 9. Satisfaction of relational needs is measured using RNS-20 at the beginning of treatment, weekly during treatment, and at termination.

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026