Recruiting
Phase 2

Distress Tolerance

Sponsor:

University of South Florida

Code:

NCT01741415

Conditions

Substance Dependence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SIDI

SC

Study Details

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.

Conditions

Substance Dependence

Study ID

NCT01741415

Start date

May 13, 2013

Status verified date

May, 2017

Completion date

Sep 1, 2019

Anticipated

Primary completion date

Sep 12, 2018

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SIDI

Skills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance

placebo comparator: SC

supportive counseling; psychological placebo/talk therapy - aimed at controlling for non-specific therapeutic factors

Interventions

SIDI

SC

Primary outcome measure

  • abstinence at 1, 3, 6 & 12 month follow-up [ Time Frame: 1, 3, 6 month follow-up post-treatment ]

Central Contacts and Locations

Central contacts

Locations

Agency for Community Treatment Services, Inc

Recruiting

Tarpon Springs, Florida, United States

Contacts

Christa Trenz-Brower,, MA

christa7@USF.EDU

Principal Investigator:

Marina A Bornovalova, Ph.D.

More Information

Sponsor

University of South Florida

Last update posted

Oct 11, 2018

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2018-10-11.