NCT01741415

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
325

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

May 13, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 11, 2018

Status Verified

May 1, 2017

Enrollment Period

5.3 years

First QC Date

November 30, 2012

Last Update Submit

October 10, 2018

Conditions

Substance Dependence

Outcome Measures

Primary Outcomes (1)

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

    Measured via biological verification and timeline follow-back

    1, 3, 6 month follow-up post-treatment

Secondary Outcomes (1)

  • distress tolerance

    1, 3, 6 month follow-up

Other Outcomes (4)

  • 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

    1, 3, 6 month follow-up in community

  • psychiatric distress

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

  • +1 more other outcomes

Study Arms (2)

SIDI

EXPERIMENTAL

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

Behavioral: SIDI

SC

PLACEBO COMPARATOR

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

Behavioral: SC

Interventions

SIDIBEHAVIORAL
Also known as: Skills for improving distress intolerance
SIDI
SCBEHAVIORAL
Also known as: supportive counseling
SC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agency for Community Treatment Services, Inc

Tarpon Springs, Florida, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39541537DERIVED

  • 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.

    PMID: 34521057DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Kelly Lane, BA

CONTACT

813-974-9030kellylane@mail.usf.edu

Marina Bornovalova, PhD

CONTACT

3123990983bornovalova@usf.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

May 13, 2013

Primary Completion

September 12, 2018

Study Completion

September 1, 2019

Last Updated

October 11, 2018

Record last verified: 2017-05

Locations

US(1)