Distress Tolerance Treatment for Substance Users

Substance Dependence Clinical Trial

Official title:

Distress Tolerance Treatment for Substance Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01741415
• Other study ID #: R01DA032582
• Status: Recruiting
• Phase: Phase 2
• Start date: May 13, 2013
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2017
• Source: University of South Florida
• Contact: Kelly Lane, BA
• Phone: 813-974-9030
• Email: kellylane[@]mail.usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: September 1, 2019
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• SIDI

• SC

Locations

Country	Name	City	State
United States	Agency for Community Treatment Services, Inc	Tarpon Springs	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	successful/unsuccessful completion of residential addictions treatment	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
Other	time in jail	measured by public records (# of days in jail by each timepoint)	1, 3, 6 month follow-up in community
Other	psychiatric distress	psychiatric distress on brief symptom inventory	post-treatment at 3 month mark in residential facility, 1, 3, 6 month follow-up in community
Other	maladaptive personality	change in maladaptive personality on the Personality Inventory for DSM5	post-treatment (at 3 month mark in residential facility), 1, 3, 6 month follow-up in community
Primary	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	distress tolerance	ability to tolerate psychological distress	1, 3, 6 month follow-up