Biofeedback for Adolescent Cannabis Use Disorder

April 28, 2015 updated by: Denver Health and Hospital Authority
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive behavioral therapy (CBT) alone
Behavioral: CBT
Experimental: Cognitive behavioral therapy plus HRV biofeedback
Behavioral: Heart rate variability biofeedback

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Investigators

  • Principal Investigator: Christian Thurstone, M.D., Denver Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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