Distress Tolerance Treatment for Substance Users

NCT ID: NCT01741415

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-13

Study Completion Date

2019-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SIDI

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

Group Type EXPERIMENTAL

SIDI

Intervention Type BEHAVIORAL

SC

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

Group Type PLACEBO_COMPARATOR

SC

Intervention Type BEHAVIORAL

Interventions

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SIDI

Intervention Type BEHAVIORAL

SC

Intervention Type BEHAVIORAL

Other Intervention Names

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Skills for improving distress intolerance supportive counseling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Agency for Community Treatment Services, Inc

Tarpon Springs, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelly Lane, BA

Role: CONTACT

813-974-9030

Marina Bornovalova, PhD

Role: CONTACT

3123990983

Facility Contacts

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Christa Trenz-Brower,, MA

Role: primary

References

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Fatimah H, Hunter MD, Bornovalova MA. Modeling the dynamics of addiction relapse via the double-well potential system. J Psychopathol Clin Sci. 2025 Jan;134(1):69-80. doi: 10.1037/abn0000960. Epub 2024 Nov 14.

Reference Type DERIVED
PMID: 39541537 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34521057 (View on PubMed)

Other Identifiers

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R01DA032582

Identifier Type: NIH

Identifier Source: org_study_id

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