Clinical trial NCT03356210: Neurofeedback Training for the Treatment of Substance Use Disorders
Official title: Quantitative Electroencephalography and Neurofeedback Training for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2017-11-29
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: After the intervention (approx 5 months)
measure: Quality of life at 3 months follow up
timeFrame: Short term outcome - 3 months follow-up
measure: Quality of life at 12 months follow-up
timeFrame: Long-term outcome - 12 months follow-up
Secondary outcomes:
measure: Perceived functioning/well-being
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
measure: Perceived psychological distress
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
measure: Substance use
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
measure: Physiological variables
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
measure: Drop-out
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
measure: Restlessness & trepidation
timeFrame: After the intervention (approx 5 months) and 3 & 12 months follow-up
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
state: Vest Agder
Study officials:
affiliation: Addiction Unit, Sorlandet Hospital HF
name: John-Kåre Vederhus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.