Clinical trial NCT01741415: Distress Tolerance Treatment for Substance Users
Official title: Distress Tolerance Treatment for Substance Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Substance Dependence
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: abstinence at 1, 3, 6 & 12 month follow-up
timeFrame: 1, 3, 6 month follow-up post-treatment
Secondary outcomes:
measure: distress tolerance
timeFrame: 1, 3, 6 month follow-up
Other outcomes:
measure: successful/unsuccessful completion of residential addictions treatment
timeFrame: Baseline, post-treatment (at 3 month mark in residential facility), successful discharge within 6 months from residential facility
measure: time in jail
timeFrame: 1, 3, 6 month follow-up in community
measure: psychiatric distress
timeFrame: post-treatment at 3 month mark in residential facility, 1, 3, 6 month follow-up in community
measure: maladaptive personality
timeFrame: post-treatment (at 3 month mark in residential facility), 1, 3, 6 month follow-up in community
Locations:
city: Tarpon Springs
country: United States
facility: Agency for Community Treatment Services, Inc
state: Florida
Study officials:
References:
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.