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Distress Tolerance Treatment for Substance Users

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ClinicalTrials.gov Identifier: NCT01741415
Recruitment Status : Recruiting
First Posted : December 4, 2012
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:

Despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. Previous research indicates that an individual's ability to withstand psychological distress is a key factor necessary to maintain drug and alcohol abstinence and to remain in substance use treatment without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features skills training in behavioral and acceptance strategies and intentional clinical exposure to emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement in distress tolerance than those in two comparison groups (receiving treatment-as-usual and supportive counseling).

Current study. The investigators received NIDA funding to conduct a randomized clinical trial with 325 clients entering a residential substance use treatment facility. Study participants will be randomized into two treatment groups: (1) those receiving SIDI and (2) those receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a period of 4 months. Then, the investigators will follow clients for one year to examine treatment retention and abstinence.


Condition or disease Intervention/treatment Phase
Substance Dependence Behavioral: SIDI Behavioral: SC Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distress Tolerance Treatment for Substance Users
Study Start Date : May 13, 2013
Actual Primary Completion Date : September 12, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Experimental: SIDI
Skills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance
Behavioral: SIDI
Other Name: Skills for improving distress intolerance

Placebo Comparator: SC
supportive counseling; psychological placebo/talk therapy - aimed at controlling for non-specific therapeutic factors
Behavioral: SC
Other Name: supportive counseling




Primary Outcome Measures :
  1. abstinence at 1, 3, 6 & 12 month follow-up [ Time Frame: 1, 3, 6 month follow-up post-treatment ]
    Measured via biological verification and timeline follow-back


Secondary Outcome Measures :
  1. distress tolerance [ Time Frame: 1, 3, 6 month follow-up ]
    ability to tolerate psychological distress


Other Outcome Measures:
  1. successful/unsuccessful completion of residential addictions treatment [ Time Frame: Baseline, post-treatment (at 3 month mark in residential facility), successful discharge within 6 months from residential facility ]
    successful/unsuccessful completion of residential addictions treatment

  2. time in jail [ Time Frame: 1, 3, 6 month follow-up in community ]
    measured by public records (# of days in jail by each timepoint)

  3. psychiatric distress [ Time Frame: post-treatment at 3 month mark in residential facility, 1, 3, 6 month follow-up in community ]
    psychiatric distress on brief symptom inventory

  4. maladaptive personality [ Time Frame: post-treatment (at 3 month mark in residential facility), 1, 3, 6 month follow-up in community ]
    change in maladaptive personality on the Personality Inventory for DSM5



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 18-65 years of age
  • Not evidencing severe cognitive deficits
  • Ability to give informed consent

Exclusion criteria:

  • <18 years of age or > 65 years of age
  • Not evidencing severe cognitive deficits (site designation of 'not competent to stand trial')
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741415


Contacts
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Contact: Kelly Lane, BA 813-974-9030 kellylane@mail.usf.edu
Contact: Marina Bornovalova, PhD 3123990983 bornovalova@usf.edu

Locations
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United States, Florida
Agency for Community Treatment Services, Inc Recruiting
Tarpon Springs, Florida, United States
Contact: Christa Trenz-Brower,, MA       christa7@USF.EDU   
Principal Investigator: Marina A Bornovalova, Ph.D.         
Sponsors and Collaborators
University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01741415     History of Changes
Other Study ID Numbers: R01DA032582 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2017

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders