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Biofeedback for Adolescent Cannabis Use Disorder

D

Denver Health and Hospital Authority

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Adolescent Cannabis Use Disorder

Treatments

Behavioral: Heart rate variability biofeedback
Behavioral: CBT

Study type

Interventional

Funder types

Other

Identifiers

NCT02059083
13-0412

Details and patient eligibility

About

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).

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Cognitive behavioral therapy (CBT) alone
Active Comparator group
Treatment:
Behavioral: CBT
Cognitive behavioral therapy plus HRV biofeedback
Experimental group
Treatment:
Behavioral: Heart rate variability biofeedback

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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