The effect of biofeedback therapy in psychiatric rehabilitation
| ISRCTN | ISRCTN78612833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78612833 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Grant number 550 |
| Sponsor | Medical University of Lublin |
| Funder | Ministerstwo Nauki i Szkolnictwa Wyższego |
- Submission date
- 06/04/2021
- Registration date
- 18/05/2021
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Schizophrenia is characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. The aim of this study is to find out whether neurofeedback can be a new form of therapeutic/rehabilitation intervention for people with schizophrenia. The study involves comparing an existing form of standard rehabilitation with a new galvanic skin response neurofeedback (GSR-NF) therapy.
Who can participate?
Male patients aged 18 to 65 with a diagnosis of schizophrenia, in remission for 1.5 years or more
What does the study involve?
Participants are randomly allocated to three groups. Group 1 receive standard rehabilitation interventions. Group 2 receive a standard rehabilitation program according to an established schedule. Group 3 undergo GSR-NF training. The rehabilitation measures are carried out over a period of 3 months. The initial and final measurements are compared in each group.
What are the possible benefits and risks of participating?
Biofeedback therapy may be an alternative solution to standard rehabilitation activities carried out in patients with mental illness.
Where is the study run from?
Medical University of Lublin (Poland)
When is the study starting and how long is it expected to run for?
February 2016 to January 2021
Who is funding the study?
Ministry of Science and Higher Education (Poland)
Who is the main contact
Renata Markiewicz
renata.markiewicz@umlub.pl
Contact information
Scientific
Psychiatric Nursing Department
Faculty of Health Sciences
Medical University of Lublin
Lublin
20-081
Poland
 ORCID ID |
0000-0003-4626-8128 |
|---|---|
| Phone | +48 (0)603768528 |
| renata.markiewicz@umlub.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-center randomized study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Improving clinical, cognitive, and psychosocial dysfunction in patients with schizophrenia: a neurofeedback study |
| Study acronym | RehBF-Schizophrenia |
| Study objectives | According to the research hypothesis, neurofeedback training improves the functioning of people with schizophrenia to a greater extent than standard rehabilitation alone, which can be demonstrated by: 1. Reduction of the severity of psychopathological symptoms (scale: PANSS) 2. Improvement in cognitive and psychosocial performance (scales: BCIS, CTT-1, CTT-2, d2, AIS and GSES) which all correspond to biochemical and electrophysiological effects: 3. Biochemical markers e.g. BDNF (brain-derived neurotrophic factor) serum level 4. Event-related potentials (ERP) and quantitative electroencephalography – neurofeedback-dependent (QEEG-NF) |
| Ethics approval(s) | Approved 25/02/2016, Bioethics Committee of the Medical University of Lublin (Al. Racławickie 1, 20-059 Lublin; room 132, Poland; +48 (0)81448 5213; komisja.bioetyczna@umlub.pl), ref: KE-0254/35/2016 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Patients are randomly assigned to three groups: Group 1 receive standard rehabilitation interventions (n = 18) Group 2 receive a standard rehabilitation program according to an established schedule (n = 26) Group 3 undergo galvanic skin response neurofeedback (GSR-NF) training (n = 19) The rehabilitation measures are carried out over a period of 3 months. The initial and final measurements are compared in each group based on the adopted research tools (according to the research protocol). |
| Intervention type | Behavioural |
| Primary outcome measure(s) | Measured at the beginning of the study and after 3 months: 1. Psychopathological symptoms measured using the Positive and Negative Syndrome Scale (PANSS) 2. Cognitive and psychosocial performance measured using the Beck Cognitive Insight Scale (BCIS), Color Trails Test (CTT)-1, CTT-2, d2, Acceptance of Illness Scale (AIS) and General Self-efficacy Scale (GSES) 3. Biochemical markers e.g. serum level of brain-derived neurotrophic factor (BDNF) 4. Event-related potentials (ERP) and quantitative electroencephalography – neurofeedback-dependent (QEEG-NF) |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 11/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target sample size at registration | 63 |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Patients diagnosed with schizophrenia (DSM-5), residual, in partial remission for ≥1.5 years 2. Patient’s consent 3. Aged 18-65 years 4. Right-handedness |
| Key exclusion criteria | 1. Current neurological diseases 2. Mental disability 3. Alcohol or psychoactive substances addiction |
| Date of first enrolment | 25/09/2016 |
| Date of final enrolment | 23/12/2019 |
Locations
Countries of recruitment
- Poland
Study participating centre
Lublin
20-059
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The database and documentation of the study are held by the principal investigator Renata Markiewicz (under copyright), and can be made available upon request from renata.markiewicz@umlub.pl. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/08/2021 | 12/04/2022 | Yes | No | |
| Results article | 11/06/2022 | 14/06/2023 | Yes | No | |
| Results article | 06/09/2022 | 14/06/2023 | Yes | No | |
| Results article | Pre- and posttherapy primary outcomes | 12/08/2021 | 07/07/2025 | Yes | No |
| Results article | associations of the reelin blood level with clinical and neurocognitive parameters | 10/07/2024 | 07/07/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 01/06/2021 | No | No |
Additional files
- ISRCTN78612833_PROTOCOL.pdf
- Uploaded 01/06/2021
Editorial Notes
07/07/2025: Publication references added.
14/06/2023: Publication references added.
12/04/2022: Publication reference added.
01/06/2021: Uploaded protocol file (not peer reviewed).
12/04/2021: Trial's existence confirmed by the Bioethics Committee of the Medical University of Lublin.
