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Distress Tolerance Treatment for Substance Users

Primary Purpose

Substance Dependence

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SIDI
SC
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Agency for Community Treatment Services, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SIDI

SC

Arm Description

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

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

Outcomes

Primary Outcome Measures

abstinence at 1, 3, 6 & 12 month follow-up
Measured via biological verification and timeline follow-back

Secondary Outcome Measures

distress tolerance
ability to tolerate psychological distress

Full Information

First Posted
November 30, 2012
Last Updated
October 10, 2018
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01741415
Brief Title
Distress Tolerance Treatment for Substance Users
Official Title
Distress Tolerance Treatment for Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2013 (undefined)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIDI
Arm Type
Experimental
Arm Description
Skills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance
Arm Title
SC
Arm Type
Placebo Comparator
Arm Description
supportive counseling; psychological placebo/talk therapy - aimed at controlling for non-specific therapeutic factors
Intervention Type
Behavioral
Intervention Name(s)
SIDI
Other Intervention Name(s)
Skills for improving distress intolerance
Intervention Type
Behavioral
Intervention Name(s)
SC
Other Intervention Name(s)
supportive counseling
Primary Outcome Measure Information:
Title
abstinence at 1, 3, 6 & 12 month follow-up
Description
Measured via biological verification and timeline follow-back
Time Frame
1, 3, 6 month follow-up post-treatment
Secondary Outcome Measure Information:
Title
distress tolerance
Description
ability to tolerate psychological distress
Time Frame
1, 3, 6 month follow-up
Other Pre-specified Outcome Measures:
Title
successful/unsuccessful completion of residential addictions treatment
Description
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
Title
time in jail
Description
measured by public records (# of days in jail by each timepoint)
Time Frame
1, 3, 6 month follow-up in community
Title
psychiatric distress
Description
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
Title
maladaptive personality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Lane, BA
Phone
813-974-9030
Email
kellylane@mail.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Bornovalova, PhD
Phone
3123990983
Email
bornovalova@usf.edu
Facility Information:
Facility Name
Agency for Community Treatment Services, Inc
City
Tarpon Springs
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christa Trenz-Brower,, MA
Email
christa7@USF.EDU
First Name & Middle Initial & Last Name & Degree
Marina A Bornovalova, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
34521057
Citation
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.
Results Reference
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Distress Tolerance Treatment for Substance Users

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