Condition category
Signs and Symptoms
Date applied
09/05/2018
Date assigned
14/05/2018
Last edited
14/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mental health professionals, as well as doctors, often see patients presenting physical symptoms for which a physical cause is either absent or does not explain these complaints sufficiently. While in general language these conditions are often called “psychosomatic” (caused by a mental factor) the term “medically unexplained physical symptoms” (MUPS) has been coined in the medical context. Given the importance of psychological factors in the cause of MUPS, psychological treatments represent a promising approach to the treatment of patients with MUPS. However, reviews and meta-analyses have shown that while various forms of psychological treatments are effective in the treatment of MUPS, the ability to get results is rather low. While some studies indicated that higher effects may be achieved by longer treatments and by more complex approaches, the volume of research is small. Therefore, the full potential of psychological treatments for MUPS remains unexplored.
This study aims to assess the effectiveness of a multi-component psychological treatment in the treatment of patients with MUPS and to examine the process of the therapeutic change.

Who can participate?
Adult patients aged over 18 years who enter group-based psychological treatment in the participating clinics.

What does the study involve?
Participants receive a psychological treatment made up of group psychotherapy, supplemented by activities such as relaxation training, yoga, and art therapy. It is provided on daily basis (5 days/week) for a period of 6 to 12 weeks.

What are the possible benefits and risks of participating?
We do not anticipate any side effects of the participation in our study.

Where is the study run from?
1. Psychosomatic Clinic, Prague (Czech Republic)
2. Psychotherapeutic and Psychosomatic Clinic ESET, Prague (Czech Republic)
3. Day Care Center „Karlov”, Psychiatric Clinic of the General University Hospital in Prague (Czech Republic)
4. Day Care Center Horní Palata, General University Hospital in Prague (Czech Republic)
5. Psychiatric Hospital, Šternberk (Czech Republic)

When is the study starting and how long is it expected to run for?
January 2018 to December 2020

Who is funding the study?
The Czech Science Foundation (Czech Republic)
Grantová Agentura České Republiky

Who is the main contact?
Dr Tomáš Řiháček (Scientific)
rihacek@fss.muni.cz

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tomáš Řiháček

ORCID ID

http://orcid.org/0000-0001-5893-9289

Contact details

Department of Psychology
Faculty of Social Studies
Masaryk University
Joštova 10
Brno
602 00
Czech Republic
+420 549 494 871
rihacek@fss.muni.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GA18-08512S

Study information

Scientific title

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

Acronym

Study hypothesis

EFFECTIVENESS HYPOTHESES
H1: Patients with medically unexplained physical symptoms (MUPS) report decrease in the intensity of MUPS after psychotherapy (primary outcome).
H2: Patients with MUPS report decrease in depression after psychotherapy.
H3: Patients with MUPS report decrease in anxiety after psychotherapy.
H4: Patients with MUPS report decrease in general distress after psychotherapy.
H5: Patients with MUPS report increase in well-being after psychotherapy.
H6: Patients with MUPS report increase in role functioning after psychotherapy.

CHANGE MECHANISM HYPOTHESES
H7: Decrease in MUPS intensity is preceded by increase in somatic awareness.
H8: Decrease in MUPS intensity is preceded by increase in emotional regulation skills.
H9: Decrease in MUPS intensity is preceded by increase in acceptance of symptoms.
H10: Decrease in MUPS intensity is preceded by increase in satisfaction of a patient's relational needs.
H11: Decrease in MUPS intensity is preceded by increase in the clarification of meaning.
H12: Decrease in MUPS intensity is predicted by the quality of therapeutic alliance.
H13: Decrease in MUPS intensity is predicted by the quality of group cohesion.

Ethics approval

1. Research Ethics Committee of Masaryk University, 30/01/2018, ref: EKV-2017-029-R1
2. Ethics Committee of the General University Hospital Prague, 15/02/2018, ref: 2143/17 S-IV

Study design

Multicentre pre-post study of psychotherapy effectiveness

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Medically unexplained physical symptoms (MUPS)

Intervention

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 of 6 to 12 weeks, supplemented by activities such as relaxation training, yoga, and art therapy. This is a naturalistic study and the intervention is not at the discretion of the investigator. While the composition of the treatment package differs slightly across participating clinics, the defining aspect (i.e., group psychotherapy) is present in all settings.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

01/01/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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).

Recruitment start date

26/01/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Psychosomatická klinika
Patočkova 3
Prague
169 00
Czech Republic

Trial participating centre

Denní sanatorium Horní Palata Všeobecné fakultní nemocnice v Praze a 1. lékařské fakulty Univerzity Karlovy
U Nesypky 28
Prague
150 00
Czech Republic

Trial participating centre

Denní stacionář Karlov Všeobecné fakultní nemocnice v Praze a 1. lékařské fakulty Univerzity Karlovy
Ke Karlovu 11
Prague
121 08
Czech Republic

Trial participating centre

Psychoterapeutická a psychosomatická klinika ESET
Úvalská 47
Prague
100 00
Czech Republic

Trial participating centre

Psychiatrická léčebna Šternberk
Olomoucká 173
Šternberk
785 01
Czech Republic

Sponsor information

Organisation

Faculty of Social Studies, Masaryk University

Sponsor details

Joštova 10
Brno
602 00
Czech Republic

Sponsor type

University/education

Website

http://fss.muni.cz

Funders

Funder type

Research organisation

Funder name

Grantová Agentura České Republiky

Alternative name(s)

Grant Agency of the Czech Republic, Czech Science Foundation, GA ČR, GACR, GAČR

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Czech Republic

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Tomáš Řiháček, rihacek@fss.muni.cz

Intention to publish date

31/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes