Effectiveness of psychotherapy in patients with medically unexplained physical symptoms
| ISRCTN | ISRCTN13532466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13532466 |
| Secondary identifying numbers | GA18-08512S |
- Submission date
- 09/05/2018
- Registration date
- 14/05/2018
- Last edited
- 05/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Department of Psychology
Faculty of Social Studies
Masaryk University
Joštova 10
Brno
602 00
Czech Republic
 ORCID ID |
0000-0001-5893-9289 |
|---|---|
| Phone | +420 549 494 871 |
| rihacek@fss.muni.cz |
Study information
| Study design | Multicentre pre-post study of psychotherapy effectiveness |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effectiveness of psychotherapy in patients with medically unexplained physical symptoms: A multi-site naturalistic study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2018 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 444 |
| Key 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 |
| Key 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). |
| Date of first enrolment | 26/01/2018 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Prague
169 00
Czech Republic
Prague
150 00
Czech Republic
Prague
121 08
Czech Republic
Prague
100 00
Czech Republic
Havlíčkův
Brod
580 01
Czech Republic
Hradec
Králové
500 05
Czech Republic
Ostrava-Poruba
708 52
Czech Republic
Sponsor information
University/education
Joštova 10
Brno
602 00
Czech Republic
| Website | http://fss.muni.cz |
|---|---|
"ROR" |
https://ror.org/02j46qs45 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Grant Agency of the Czech Republic, Czech Science Foundation, Grantová agentura ČR, Grantové agentury, GrantovaAgentura, GAČR, GACR, GA ČR, GA CR
- Location
- Czech Republic
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | Current IPD sharing statement as of 26/03/2019: The individual participant questionnaire data collected during the trial will be shared, after deidentification. The data will be made available upon reasonable request for three years after the end of the project. Afterwards, it will be made available to anyone who wishes to access it with no end date. The Data Set, Statistical Analysis Plan and Analytic Code will be made available at https://osf.io/dfrma/ Previous 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2022 | 04/07/2022 | Yes | No |
Editorial Notes
05/07/2022: The intention to publish date has been changed from 30/06/2022 to 31/12/2022.
04/07/2022: Publication reference added.
22/10/2021: Internal review.
08/07/2021: The following changes have been made:
1. The intention to publish date has been changed from 31/01/2021 to 30/06/2022.
2. The total final enrolment number has been changed from 449 to 444.
14/02/2020: Total final enrolment number added.
26/03/2019: The following changes were made to the trial record:
1. Trial participating centres were added (Psychiatrická nemocnice Havlíčkův Brod, Psychiatrická klinika Fakultní nemocnice Hradec Králové, Fakultní nemocnice Ostrava, Oddělení psychiatrické)
2. A trial participating centre was removed (Psychiatrická léčebna Šternberk).
3. The IPD sharing statement was added to the publication and dissemination plan.
