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Neurofeedback Training for the Treatment of Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356210
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF

Study Description
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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.


Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Neurofeedback Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research assistants doing follow-up assessment will be blinded to condition assignment
Primary Purpose: Treatment
Official Title: Quantitative Electroencephalography and Neurofeedback Training for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : January 19, 2021
Actual Study Completion Date : January 19, 2021
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Treatment as usual (TAU)
This control group will receive treatment as usual; conventional counseling
Experimental: Neurofeedback + TAU
20 sessions of symptom-based NF training in conjunction with traditional therapy
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356210


Locations
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Norway
Sorlandet Hospital HF
Kristiansand, Vest Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Principal Investigator: John-Kåre Vederhus, PhD Addiction Unit, Sorlandet Hospital HF
  Study Documents (Full-Text)

Documents provided by Sorlandet Hospital HF:
Study Protocol and Statistical Analysis Plan  [PDF] March 17, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT03356210    
Other Study ID Numbers: SSHF_2017
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After study completion and writing up of results, expected 31.12.22
Access Criteria: Open

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders