Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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Detailed Description
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1. TAU + Neurofeedback using a PC-screen (experimental group)
2. TAU as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial.
The 30 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.
Participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neurofeedback
24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.
Neurofeedback
A device that assists in training patients in relaxing.
Waiting list
Those assigned to waiting list will be able to pick one of the two interventions at the end of the study.
No interventions assigned to this group
Interventions
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Neurofeedback
A device that assists in training patients in relaxing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)
* AUDIT cut off \<16
* DUDIT cut off \<8
* Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.
* 18 years or older
Exclusion Criteria
* Ongoing traumatic exposure (such as domestic violence)
* Balance problems
* Active suicide risk or life-threatening self-harm
* A diagnosis of schizophrenia or psychotic disorder
* Ongoing compulsory care
* If the patient changes dose or medication strategy during the trial.
* If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.
18 Years
ALL
No
Sponsors
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Steinn Steingrimsson
OTHER
Responsible Party
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Steinn Steingrimsson
Principal investigator & clinical associate professor
Principal Investigators
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Steinn Steingrimsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SUNF001
Identifier Type: -
Identifier Source: org_study_id
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