CClinicalTrials.gg
Status unknownNCT01741415Updated Oct 11, 2018

Distress Tolerance Treatment for Substance Users

A Phase 2 interventional study of SIDI and SC in Substance Dependence, sponsored by University of South Florida. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-11.

Sponsored by University of South Florida · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Substance Dependence
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 325 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
325 participants (estimated)

Study arms

  • Experimental
    SIDI

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

    Behavioral: SIDI

  • Placebo comparator
    SC

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

    Behavioral: SC

Interventions

  • BehavioralSIDI

    Also known as: Skills for improving distress intolerance

  • BehavioralSC

    Also known as: supportive counseling

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What researchers measure

Primary outcomes

  1. abstinence at 1, 3, 6 & 12 month follow-up

    Measured via biological verification and timeline follow-back

    Time frame: 1, 3, 6 month follow-up post-treatment

Secondary outcomes

  1. distress tolerance

    ability to tolerate psychological distress

    Time frame: 1, 3, 6 month follow-up

Other outcomes

  1. successful/unsuccessful completion of residential addictions treatment

    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

  2. time in jail

    measured by public records (# of days in jail by each timepoint)

    Time frame: 1, 3, 6 month follow-up in community

  3. psychiatric distress

    psychiatric distress on brief symptom inventory

    Time frame: post-treatment at 3 month mark in residential facility, 1, 3, 6 month follow-up in community

  4. maladaptive personality

    change in maladaptive personality on the Personality Inventory for DSM5

    Time frame: post-treatment (at 3 month mark in residential facility), 1, 3, 6 month follow-up in community

07

Study locations

1 of 1 sites recruiting
  • Agency for Community Treatment Services, Inc
    Tarpon Springs, Florida, United States
    • Christa Trenz-Brower,, MA · Contact · christa7@USF.EDU
    • Marina A Bornovalova, Ph.D. · Principal investigator
    Recruiting
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References and documents

Publications

  • Choate AM, Gorey C, Rappaport LM, Wiernik BM, Bornovalova MA. Alternative model of personality disorders traits predict residential addictions treatment completion. Drug Alcohol Depend. 2021 Nov 1;228:109011. doi: 10.1016/j.drugalcdep.2021.109011. Epub 2021 Sep 1. PubMed 34521057 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01741415
Lead sponsor
University of South Florida
Responsible party
Sponsor
First posted
Dec 4, 2012
Start date
May 13, 2013
Primary completion
Sep 12, 2018
Completion
Sep 1, 2019 (estimated)
Last update
Oct 11, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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