Biofeedback for Adolescent Cannabis Use Disorder

Overview

The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014

Interventions

  • Behavioral: Heart rate variability biofeedback
  • Behavioral: CBT

Arms, Groups and Cohorts

  • Active Comparator: Cognitive behavioral therapy (CBT) alone
  • Experimental: Cognitive behavioral therapy plus HRV biofeedback

Clinical Trial Outcome Measures

Primary Measures

  • Change in Perceived Stress Scale
    • Time Frame: baseline and 16 weeks

Secondary Measures

  • Change in the number of days used marijuana in the past 28 days
    • Time Frame: baseline and 16 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor – meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview; – be medically healthy; – be willing to participate in the study intervention and assessments; – plan to live locally for at least 4 months; – be able to read English well enough to complete study questionnaires; – have self-reported cannabis use in the past 28 days; – have a Perceived Stress Scale score > 20. Exclusion Criteria:

  • current or past psychosis; – bipolar I or II disorder; – the need to take psychotropic medications at any time during the study; – pregnancy; – psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and – medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Denver Health and Hospital Authority
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christian Thurstone, M.D., Principal Investigator, Denver Health

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