Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users (DISC)

August 31, 2026 updated by: Rick James Macatee, Florida State University

Refinement and Testing of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance , which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed project aims to optimize an existing two-session computerized distress tolerance intervention and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session, its active ingredient bolstered, and augmented with smart phone-delivered therapy reminders. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. Distress intolerance, cannabis use, and psychosocial functioning outcomes will be evaluated. As an exploratory aim, a wristworn device will be used to measure objective stress responding in the real-world during the intervention period. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance, which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed Stage I project aims to modify an existing two-session computerized distress tolerance intervention to optimize emotion regulation learning/generalization and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session and its imaginal exposure module will be modified to shape emotional engagement with the aim of maximizing within-session habituation, which will be signaled with a novel audio/visual cue (habituation cue). Habituation cues will then be delivered in just-in-time text message reminders triggered by naturalistic distress reported via ecological momentary assessment. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. To measure the intervention's mechanistic target engagement, multi-method distress intolerance assessments will be administered through four-month follow-up. To measure the intervention's impact on cannabis use, stress-related cannabis use motivation (lab stress- elicited craving and neurophysiological drug cue reactivity, ecological momentary assessment of stress-elicited cannabis use) will be assessed through the intervention period. Interviewer-assessed cannabis use frequency, CUD severity, and urinary THC metabolite concentration will be measured through 4-month follow-up. Quality of life and anxiety/depression symptoms will also be measured as secondary outcomes through 4-month follow-up. As an exploratory aim, a wristworn device will be used to measure ambulatory physiology during a portion of the intervention period to evaluate the feasibility of detecting heightened real- world distress based on objective indicators. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions in multi-method assessments of distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning. Successful completion of the proposed aims will (1) justify a subsequent Stage II trial, and (2) inform efforts to integrate the just-in-time habituation reminders with wearable technology in order to increase emotion regulation generalization opportunities and decrease participant report burden.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zoe Howell Project Coordinator, BS
  • Phone Number: 850-644-2445
  • Email: brains@psy.fsu.edu

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306-4301
        • The BRAINS Lab at Florida State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cannabis is the primary substance of abuse.
  • Clinical-level Distress intolerance Index score.
  • Current Cannabis Use Disorder diagnosis.
  • Near-daily to daily cannabis use in past-month and past 3 months.
  • Positive urine screen for THC
  • Detectable skin conductance level
  • Owns a smart phone
  • Primary smoked/vaporized delta-9 or delta-8 THC user

Exclusion Criteria:

  • Presence of acute/major psychiatric disturbance
  • Current pregnancy
  • Change in psychotropic medication within the past month
  • Concurrently receiving treatment for cannabis use
  • Concurrently receiving dialectical behavior therapy or exposure-based therapy for emotional disorders
  • Planning to immediately quit using cannabis
  • EEG contraindications
  • Kidney disease

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Emotional Engagement Distress Tolerance Intervention
The experimental intervention (single 2.5 hour session) is comprised of video-delivered psychoeducation, adaptive skill practice, and emotional exposure. During exposure, a sequence of percussive sounds accompanied by a visual depiction of the participant's skin conductance level during exposure will be presented at the moment the participant's skin conductance returns to the relaxation baseline value. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.
Behavioral: Emotional Engagement Distress Tolerance Intervention
2.5 hour computerized intervention with smart phone support focused on building tolerance of emotional distress
Placebo Comparator: Health Education Intervention
The health education control intervention is a single 2.5 hour computerized session. It is comprised of audio-narrated videos on healthy habits and self-care in the domains of sleep, nutrition, hygiene, and physical exercise. The same sequence of percussive sounds used in the Emotional Engagement Distress Tolerance Intervention is presented alongside summary slides presenting key points on healthy habits and self-care. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.
Behavioral: Health Education Intervention
2.5 hour computerized intervention with smart phone support focused on building healthy habits that support stress management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapy Evaluation Questionnaire
Time Frame: Immediately after intervention session
acceptability/feasibility (credibility subscale range 3-27; expectancy item range 0%-100%; higher scores indicate better outcome)
Immediately after intervention session
Treatment Satisfaction Questionnaire
Time Frame: Post-Intervention (20 days after intervention session)
acceptability/feasibility (range 0-84; higher scores indicate better outcome)
Post-Intervention (20 days after intervention session)
Change in perceived distress intolerance from baseline through follow-up
Time Frame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Distress Intolerance Index (range 0-40; higher scores indicate worse outcome) to assess perceived distress intolerance via self-report
Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in behavioral distress intolerance from baseline through follow-up
Time Frame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Mirror-Tracing Persistence Task to assess behavioral distress intolerance via computerized task
Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in laboratory stress-induced cannabis craving from baseline through post-intervention
Time Frame: Baseline, Post-Intervention (20 days after intervention session)
Change in Marijuana Craving Questionnaire (range 11-77; higher scores indicate worse outcome) after Mannheim Multicomponent Stress Test at post-intervention compared to baseline
Baseline, Post-Intervention (20 days after intervention session)
Change in real-world stress-elicited cannabis use from baseline to post-intervention
Time Frame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session)
Change in stress->cannabis use slopes derived from ecological momentary assessment from baseline through post-intervention
Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session)
Change in cannabis use frequency from baseline through follow-up
Time Frame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in cannabis use frequency (measured via timeline follow-back) from baseline through four-month follow-up
Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in self-reported cannabis use problems from baseline through follow-up
Time Frame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in Marijuana Problems Scale (range 0-38; higher scores indicate worse outcome) from baseline through follow-up
Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in Cannabis Use Disorder symptoms from baseline through follow-up
Time Frame: Baseline, Four-Month Follow-up
Change in interviewer-assessed Cannabis Use Disorder criteria (range 0-11; higher scores indicate worse outcome) from baseline to four-month follow-up
Baseline, Four-Month Follow-up
Change in laboratory stress-induced neural reactivity to cannabis cues (assessed via the electroencephalography [EEG]-recorded late positive potential) from baseline through post-intervention
Time Frame: Baseline, Post-Intervention (20 days after intervention session)
Change in Late Positive Potential to Cannabis Cues after Mannheim Multicomponent Stress Test at post-intervention compared to baseline
Baseline, Post-Intervention (20 days after intervention session)
Change in urine tetrahydrocannabinol [THC] metabolite concentration from baseline through follow-up
Time Frame: Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in urinary THC metabolite concentration (measured via ultra high performance liquid chromatography [UHPLC]) from baseline through four-month follow-up
Baseline, Mid-Intervention (10 days after intervention session), Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in Cannabis Demand from baseline to post-intervention
Time Frame: Baseline, Post-Intervention (20 days after intervention session)
Change in Omax, Breakpoint, and Elasticity derived from Marijuana Purchase Task (higher OMax/Breakpoint and lower Elasticity indicate worse outcome) at post-intervention compared to baseline
Baseline, Post-Intervention (20 days after intervention session)
Change in cannabis use quantity from baseline to post-intervention
Time Frame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in cannabis use quantity (measured via timeline follow-back) from baseline through four-month follow-up
Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life from baseline through follow-up
Time Frame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in self-reported quality of life (measured via Quality of Life Enjoyment and Satisfaction Questionnaire Short-Form; range 16-80; lower scores indicate worse outcome) from baseline through follow-up
Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in depression and anxiety from baseline through follow-up
Time Frame: Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up
Change in self-reported depression and anxiety (measured via Hospital Anxiety and Depression Scale [range 0-21 for each subscale; higher scores indicate worse outcomes) from baseline through follow-up
Baseline, Post-Intervention (20 days after intervention session), One-Month Follow-up, Four-Month Follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Northwestern University
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard J Macatee, PhD, Florida State University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006346
  • 1R34DA057733-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings