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Completed

NCT Number: NCT03356210

Neurofeedback Training for the Treatment of Substance Use Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sorlandet Hospital HF

Kristiansand, Vest Agder, 4604, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neurofeedback

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Perceived functioning/well-being

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    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

  2. Perceived psychological distress

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    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.

  3. Substance use

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    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).

  4. Physiological variables

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    Sleep quality will be assessed using a 10-cm visual analog scale (VAS) ranging from negative (left) to positive (right).

  5. Drop-out

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    Drop-out rates from the out-patient treatment, i.e., the percentage who has dropped-out of treatment in each group.

  6. Restlessness & trepidation

    Time frame: After the intervention (approx 5 months) and 3 & 12 months follow-up

    Restlessness & trepidation will be assessed using a 10-cm visual analog scales (VAS) ranging from negative (left) to positive (right).

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Quantitative Electroencephalography and Neurofeedback Training for the Treatment of Substance Use Disorders: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2017
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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