Distress Tolerance Treatment for Substance Users

October 10, 2018 updated by: University of South Florida

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

325

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Tarpon Springs, Florida, United States
        • Recruiting
        • Agency for Community Treatment Services, Inc
        • Contact:
        • Principal Investigator:
          • Marina A Bornovalova, Ph.D.

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SIDI
Skills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance
Behavioral: SIDI
Other Names:
  • 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 Names:
  • supportive counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 3, 6 month follow-up post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distress tolerance
Time Frame: 1, 3, 6 month follow-up
ability to tolerate psychological distress
1, 3, 6 month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post-treatment (at 3 month mark in residential facility), successful discharge within 6 months from residential facility
time in jail
Time Frame: 1, 3, 6 month follow-up in community
measured by public records (# of days in jail by each timepoint)
1, 3, 6 month follow-up in community
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
post-treatment at 3 month mark in residential facility, 1, 3, 6 month follow-up in community
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
post-treatment (at 3 month mark in residential facility), 1, 3, 6 month follow-up in community

Collaborators and Investigators

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

Sponsor

University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 13, 2013

Primary Completion (ACTUAL)

September 12, 2018

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (ESTIMATE)

December 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA032582 (NIH)

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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