Biofeedback for Adolescent Cannabis Use Disorder

Phase 1

Withdrawn

• Conditions: Adolescent Cannabis Use Disorder
• Interventions: Behavioral: Heart rate variability biofeedback; Behavioral: CBT

• Registration Number: NCT02059083
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy plus HRV biofeedback	Heart rate variability biofeedback	-
Cognitive behavioral therapy (CBT) alone	CBT	-

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale	baseline and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the number of days used marijuana in the past 28 days	baseline and 16 weeks