Neurofeedback Training for the Treatment of Substance Use Disorders

NCT03356210 | Completed

• 1 other identifier: SSHF_2017
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Long-term outcome - 12 months follow-up

Secondary Outcomes (6)

• Perceived functioning/well-being

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

• Perceived psychological distress

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

• Substance use

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

• Physiological variables

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

• Drop-out

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

Study Arms (2)

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

Behavioral: Neurofeedback

Interventions

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.

Neurofeedback + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital HF

Kristiansand, Vest Agder, 4604, Norway

Location

Related Publications (1)

• 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.

  PMID: 35705204 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• John-Kåre Vederhus, PhD

  Addiction Unit, Sorlandet Hospital HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants doing follow-up assessment will be blinded to condition assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: November 29, 2017
• Study Start: September 12, 2017
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: June 24, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After study completion and writing up of results, expected 31.12.22
• Access Criteria: Open

Locations

NO (1)