The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.
This study pilot tests a 13-week distress tolerance-based psychosocial intervention paired with a benzodiazepine taper comparing it to a relaxation therapy control condition with the aim of assisting individuals receiving OAT discontinue benzodiazepine use. All participants will receive the same benzodiazepine (BZD) discontinuation protocol. The Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention consists of 13 weeks with 5 weekly therapy sessions prior to a 9-week BZD taper. Some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using BZDs \[e.g. selective serotonin reuptake inhibitors (SSRI) for anxiety or hypnotics for insomnia\]. Data collection will occur at baseline, then weekly for 13 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) to assist individuals in tolerating benzodiazepine withdrawal symptoms and teaching skills to prevent relapse to benzodiazepine use. It will also provide psychoeducation about benzodiazepine use in OAT. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.
The relaxation therapy control condition involves psychoeducation about benzodiazepine use in OAT and progressive muscle-relaxation training. Both intervention and control arms will receive identical benzodiazepine discontinuation taper protocols.
Center for Psychiatric and Chemical Dependency Services (CPCDS)
Pittsburgh, Pennsylvania, United States
Internal Medicine Recovery Engagement Program (REP)
Pittsburgh, Pennsylvania, United States
Narcotic Addiction Treatment Program (NATP)
Wilkinsburg, Pennsylvania, United States
Number of participants who discontinued BZDs at 4-month follow-up
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 4-month follow-up corroborated by urine testing.
Time frame: 4-months
Number of participants who discontinued BZDs at 6-month follow-up
Number of participants with BZD discontinuation defined by no BZD use by self-report during the month prior to 6-month follow-up corroborated by urine testing.
Time frame: 6-months
Change in quantity of BZD use
Change in quantity of BZD used define by past-week BZD use by self-report in diazepam equivalent dose
Time frame: 4- and 6-months
Change in distress tolerance
Change in distress tolerance defined by change in Distress Intolerance Index (DII) score from baseline to 6 month follow-up. The DII is a 10-item instrument. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score (range 0-40), with higher scores indicating worse ability to tolerate distress.
Time frame: 4- and 6-months
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