Substance Use DisordersNCT03356210
Neurofeedback Training for the Treatment of Substance Use Disorders
A study testing Neurofeedback in people with Substance Use Disorders, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The proposed randomized controlled trial (RCT) will investigate the usefulness of electroencephalographic (EEG) biofeedback, also called neurofeedback (NF), a treatment method that can potentially prevent relapses among patients with a substance use disorder (SUD) through its calming effect on the central nervous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteNorway
- Study dates
- 12 Sep 2017to 19 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a substance use disorder referred to outpatient addiction treatment, aged >18 of both genders.
Who cannot join
- Severe psychiatric disorders (e.g. psychosis) that have not been stabilized with e.g., medication (assessed as a part of the clinical process at the clinic). Severe cognitive impairment or language problems (inability to converse for interviews).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Electroencephalography and Neurofeedback Training for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
The proposed randomized controlled trial (RCT) will investigate the usefulness of electroencephalographic (EEG) biofeedback, also called neurofeedback (NF), a treatment method that can potentially prevent relapses among patients with a substance use disorder (SUD) through its calming effect on the central nervous system.
The study will examine whether NF can improve general well-being and quality of life (QoL) and subsequently its ability to play a role in relapse prevention strategies. Specifically, the effect on physical and psychological distress will be investigated.
Read the detailed description
A patient with a substance use disorder (SUD) typically requires comprehensive and individualized care across different levels of service providers, from primary care to the specialist health care services. Among the known threats to a prolonged remission are negative emotional states because they can trigger the urge to use drugs. An integrative approach is warranted aimed to address the physiological, psychological and social aspects of the disorder during the rehabilitation period.
Patients with a SUD diagnosis in an outpatient clinic will be randomized to either 1) 20 sessions of symptom-based NF training in conjunction with traditional therapy or 2) conventional counseling. The primary outcome is QoL at the end of treatment and at a 3 and 12 month follow-up. Secondary outcome measures include alcohol and drug use, mental distress, sleep quality and cognitive function. The optimal quantity of the intervention will be assessed with a cost-benefit approach.
The proposed study will provide new knowledge about how NF can be best utilized in SUD treatment, potentially improving QoL and relapse rates.
- Conditions
- Substance Use Disorders
- Being tested
- Neurofeedback
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
The intervention will consist of 20 sessions of symptom-based NF tailored to the individual patient. Training will be conducted using the Othmer method of NF from EEGinfo, comprising bipolar, infra-low frequency training, with the inclusion of synchrony and alfa-/theta training as needed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | This control group will receive treatment as usual; conventional counseling |
| Neurofeedback + TAU | Experimental | 20 sessions of symptom-based NF training in conjunction with traditional therapy Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL)
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL.
Measured: After the intervention (approx 5 months)
Quality of life at 3 months follow up
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL.
Measured: Short term outcome - 3 months follow-up
Quality of life at 12 months follow-up
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL. Normative data from a previous survey of the general population showed a mean QoL score of 0.69 and a minimal clinically important difference is 0.10.
Measured: Long-term outcome - 12 months follow-up
Secondary outcomes (6)
Perceived functioning/well-being
Perceived functioning/well-being will be measured with the Outcome rating scale (ORS). The ORS each consist of four 10-cm visual analog scales (VAS) ranging from negative (left) to positive (right). The ORS measures three areas of client functioning: individual, interpersonal, and social, as well as measuring the client's overall view of their personal well-being. The marks made by clients on each of the four lines are measured to the nearest millimeter to derive the score. These are then summed to obtain a total score. Cm is analogue to scale score and the total score range from 0 to 40. High scores reflect a good level of well-being and functioning. A clinical cut-off is 25 (i.e., one would expect scores below 25 in a clinical sample) and a 5 point difference in score is consider as the minimal clinically important difference
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Perceived psychological distress
Perceived psychological distress measured with the Symptom Check List - 10 (SCL-10), a short-form of the Hopkins Symptom Checklist 90. SCL-10 has 10 items about anxiety (4 items) and depression (6 items). Responses are scored on an ordinal scale from 1 to 4, with the highest score indicating highest distress. A total mean score is calculated. Scores above 1.85 is considered a pathological score.
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Substance use
Substance use will be assessed with the European version of the Addiction Severity index (EuropASI). Data on drug and alcohol use in the 30 days before the interview are used to derive a composite score to indicate severity; scores range from 0 (no problem) to 1 (a severe problem).
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Physiological variables
Sleep quality will be assessed using a 10-cm visual analog scale (VAS) ranging from negative (left) to positive (right).
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Drop-out
Drop-out rates from the out-patient treatment, i.e., the percentage who has dropped-out of treatment in each group.
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Restlessness & trepidation
Restlessness \& trepidation will be assessed using a 10-cm visual analog scales (VAS) ranging from negative (left) to positive (right).
Measured: After the intervention (approx 5 months) and 3 & 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start12 Sep 2017
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- John-Kåre Vederhus, PhD, Principal investigator, Addiction Unit, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356210
- Sponsor's protocol ID
- SSHF_2017
- Status last verified
- Jan 2020
- First submitted
- 14 Jul 2017
- Last updated
- 24 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymized after study completion and will then be deposited to the publicly available data repository of the Norwegian Centre for Research Data.
Publications
Gabrielsen KB, Clausen T, Haugland SH, Hollup SA, Vederhus JK. Infralow neurofeedback in the treatment of substance use disorders: a randomized controlled trial. J Psychiatry Neurosci. 2022 Jun 15;47(3):E222-E229. doi: 10.1503/jpn.210202. Print 2022 May-Jun.
PubMed 35705204
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Electroencephalography and Neurofeedback Training for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03356210
- Acronym / sponsor ID
- SSHF_2017
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed randomized controlled trial (RCT) will investigate the usefulness of electroencephalographic (EEG) biofeedback, also called neurofeedback (NF), a treatment method that can potentially prevent relapses among patients with a substance use disorder (SUD) through its calming effect on the central nervous system.
The study will examine whether NF can improve general well-being and quality of life (QoL) and subsequently its ability to play a role in relapse prevention strategies. Specifically, the effect on physical and psychological distress will be investigated.
Detailed description
A patient with a substance use disorder (SUD) typically requires comprehensive and individualized care across different levels of service providers, from primary care to the specialist health care services. Among the known threats to a prolonged remission are negative emotional states because they can trigger the urge to use drugs. An integrative approach is warranted aimed to address the physiological, psychological and social aspects of the disorder during the rehabilitation period.
Patients with a SUD diagnosis in an outpatient clinic will be randomized to either 1) 20 sessions of symptom-based NF training in conjunction with traditional therapy or 2) conventional counseling. The primary outcome is QoL at the end of treatment and at a 3 and 12 month follow-up. Secondary outcome measures include alcohol and drug use, mental distress, sleep quality and cognitive function. The optimal quantity of the intervention will be assessed with a cost-benefit approach.
The proposed study will provide new knowledge about how NF can be best utilized in SUD treatment, potentially improving QoL and relapse rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –This control group will receive treatment as usual; conventional counseling |
| Neurofeedback + TAU | Experimental | Behavioral: Neurofeedback20 sessions of symptom-based NF training in conjunction with traditional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a substance use disorder referred to outpatient addiction treatment, aged >18 of both genders.
Key exclusion criteria (1 listed)
- Severe psychiatric disorders (e.g. psychosis) that have not been stabilized with e.g., medication (assessed as a part of the clinical process at the clinic). Severe cognitive impairment or language problems (inability to converse for interviews).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackThe intervention will consist of 20 sessions of symptom-based NF tailored to the individual patient. Training will be conducted using the Othmer method of NF from EEGinfo, comprising bipolar, infra-low frequency training, with the inclusion of synchrony and alfa-/theta training as needed. | Behavioural | Neurofeedback + TAU |
Primary outcome
Quality of life (QoL)
Time frame: After the intervention (approx 5 months)
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL.
Quality of life at 3 months follow up
Time frame: Short term outcome - 3 months follow-up
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL.
Quality of life at 12 months follow-up
Time frame: Long-term outcome - 12 months follow-up
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL. Normative data from a previous survey of the general population showed a mean QoL score of 0.69 and a minimal clinically important difference is 0.10.
6 secondary outcomes
Perceived functioning/well-being
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Perceived psychological distress
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Substance use
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Physiological variables
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Drop-out
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Restlessness & trepidation
Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Derived from this study: PubMed 35705204Gabrielsen KB, Clausen T, Haugland SH, Hollup SA, Vederhus JK. Infralow neurofeedback in the treatment of substance use disorders: a randomized controlled trial. J Psychiatry Neurosci. 2022 Jun 15;47(3):E222-E229. doi: 10.1503/jpn.210202. Print 2022 May-Jun.
- Individual participant dataSharing planned: Yes. Data will be anonymized after study completion and will then be deposited to the publicly available data repository of the Norwegian Centre for Research Data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John-Kåre Vederhus, PhD principal investigator
Addiction Unit, Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Substance Use Disorders, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) (time frame: After the intervention (approx 5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.