Neurofeedback Training for the Treatment of Substance Use Disorders

NCT ID: NCT03356210

Last Updated: 2021-06-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2021-01-19

Brief Summary

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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

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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

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Research assistants doing follow-up assessment will be blinded to condition assignment

Study Groups

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Treatment as usual (TAU)

This control group will receive treatment as usual; conventional counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Neurofeedback + TAU

20 sessions of symptom-based NF training in conjunction with traditional therapy

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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.

Interventions

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Neurofeedback

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with a substance use disorder referred to outpatient addiction treatment, aged \>18 of both genders.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John-Kåre Vederhus, PhD

Role: PRINCIPAL_INVESTIGATOR

Addiction Unit, Sorlandet Hospital HF

Locations

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Sorlandet Hospital HF

Kristiansand, Vest Agder, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35705204 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SSHF_2017

Identifier Type: -

Identifier Source: org_study_id

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