Evaluating Neuromodulation Technologies in Early Recovery

NCT01993277 | Unknown DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an open-label comparative effectiveness clinical trial evaluating the impact of three neuromodulation treatment devices to improve the mental health and sobriety status of recovering substance abuse patients. We intend to enroll 200 patients to give us a sufficient number of subjects for the planned comparisons. Following informed consent and baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device, once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the assigned treatments, all patients will also receive the standard array of services that are provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically appropriate, psychiatric medication management and Eye Movement Desensitization Response (EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR sessions. Patients without PTSD do not receive EMDR therapy.

Conditions

Depression; Anxiety; Insomnia

Outcome Measures

Primary Outcomes (4)

• The Quick Inventory of Depressive Symptoms-Self-Report (QIDS-SR)

  Change in baseline depressive symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup

• State-Trait Anxiety Inventory (STAI)

  Change in baseline anxiety symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup

• Pittsburgh Sleep Scale (PSS)

  Change in baseline insomnia symtpoms, after 3 weeks of treatment, and 1, 3, and 6 months followup

• 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (QLES)

  Change in baseline quality of life, after 3 weeks of treatment, and 1, 3, and 6 months followup

Secondary Outcomes (1)

• Brief Substance Craving Scale (BSCS)

  Change in baseline craving intensity after the 5th, 10th, and 15th treatment sessions

Study Arms (4)

Fischer Wallace Stimulator

ACTIVE COMPARATOR

30 20-minute sessions of the Fischer Wallace Stimulator administered twice-per-day within a 3-week time-frame;

Device: Fischer Wallace Stimulator

Nexalin Brain Stimulator

ACTIVE COMPARATOR

15 40-minute sessions of Nexalin Brain Stimulator adminsitered once-per-day within a 3-week time-frame

Device: Nexalin Brain Stimulator

DAVID Delight Stimulator

ACTIVE COMPARATOR

15 40-minute sessions of the DAVID Delight administered once-per-day within a 3-week time-frame

Device: David Delight Stimulator

Relaxation Therapy

ACTIVE COMPARATOR

15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame

Behavioral: Relaxation Therapy

Interventions

Nexalin Brain Stimulator DEVICE

Nexalin Brain Stimulator

Fischer Wallace Stimulator DEVICE

Fischer Wallace Stimulator

David Delight Stimulator DEVICE

DAVID Delight Stimulator

Relaxation Therapy BEHAVIORAL

Relaxation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.

Sponsors & Collaborators

• Behavioral Health of the Palm Beaches: lead

Study Sites (1)

Behavioral Health of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tammy Malloy, LCSW

  Behavioral Health of the Palm Beaches

  PRINCIPAL INVESTIGATOR

• Jodi Star, M.D.

  Behavioral Health of the Palm Beaches

  PRINCIPAL INVESTIGATOR

• Kate Reynolds, MSW

  Behavioral Health of the Palm Beaches

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Reynolds, MSW

CONTACT

561-465-1263; kreynolds@bhpalmbeach.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

US (1)