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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA044321-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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 who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.
This study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper 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 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then 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 starting at the baseline assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Other | This psychosocial treatment intervention uses a combination of interoceptive exposure therapy and elements of acceptance and commitment therapy (ACT) and psychoeducation about benzodiazepine use in OAT. Of note, this is a pilot trial for feasibility and acceptability. There is no randomization and we are not comparing arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | Behavioral | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Acceptability of the Interventions | Number of participants who rated the intervention as acceptable, this was assessed by conducting an in-depth exit interview with the participant once they complete the entire 13-week study. | 13 weeks |
| Number of Participants Who Rates the Intervention as Feasible | Feasibility of intervention will be measured through the number of participants recruited and enrolled in the study, number of participants who started the BZD taper, and completed assessment tools. | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Intervention | Completion of intervention will be measured through participant attendance of weekly sessions. Participants must attend all 13 sessions (Baseline, 3 weekly therapy sessions prior to taper, and 8 week BZD taper urine/drug screens). Participants, who miss a study visit, will be considered discontinued from the study if study staff are unable to get in contact with them 7 days after their missed study visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Woo Park, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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Study recruitment began in March 2021. Potential participants identified by the study PI were given study information and PI obtained verbal consent from patients to have study staff call to invite them to participate over the phone. Interested potential participants were asked to complete a brief screening interview using the study screening script that involved asking questions based on the inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol. DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | This is a pilot clinical trial of the DT-BD intervention. The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol. DT-BD is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist BZD discontinuation in patients treated with OAT. There will be 5 sessions between therapist and participant prior to the start of the BZD taper. The taper occurs over 9 weeks and involves weekly meetings with a BZD prescriber during which a gradual BZD dose reduction will take place. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Acceptability of the Interventions | Number of participants who rated the intervention as acceptable, this was assessed by conducting an in-depth exit interview with the participant once they complete the entire 13-week study. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
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13 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) | The study population will consist of outpatients receiving OAT for opioid use disorder who are also using BZDs regularly. All participants will receive the same BZD discontinuation protocol. |
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There was an intended sample of four participants, and only one out of the four participants completed the whole 13-week study. This is due to the barrier of coming in-person for their weekly appointment during the peak of COVID-19 pandemic when the vaccines were just becoming available to the public.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tae Woo Park, MD | Boston Medical Center and BU School of Medicine | 617-414-1906 | taewoo.park@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2021 | Sep 17, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2021 | Jul 31, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| BZD discontinuation protocol | Drug | All participants will undergo BZD discontinuation. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 9 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper. |
|
|
| 13 weeks |
| BZD Use Based on Self-report | Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB), adapted for BZD use. The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their BZD use 7 days prior to study visit. We will also monitor BZD use on a daily basis with a mobile phone application. | 13 weeks |
| Illicit Drug Use Based on Urine Drug Tests | Illicit drug use urine tests will screen for amphetamines, benzodiazepines, opiates, oxycodone, fentanyl, cocaine, barbiturates, and methadone. Plus: liquid chromatography-mass spectrometry for clonazepam and lorazepam, and fentanyl if fentanyl test (immunoassay) is positive. | 13 weeks |
| Alcohol Use Based on Urine Drug Tests | Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide. | 13 weeks |
| Alcohol Use Based on Self-report | Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB). The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their alcohol use 7 days prior to study visit. The alcohol adaption includes estimates of 1 standard drink in terms of beer, wine, and hard liquor. We will also monitor alcohol use on a daily basis with a mobile phone application. | 13 weeks |
| BZD Withdrawal Symptoms | BZD withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment-Benzodiazepines (CIWA-B). The CIWA-B is a 20 item instrument, to assess severity of benzodiazepine withdrawal, including nausea and vomiting, anxiety, tremor, sweating, auditory disturbances, visual disturbances, tactile disturbances, headache, agitation, and clouding of sensorium. Scores range from 0 to 80, with 1-20 mild withdrawal, 21-40 moderate withdrawal, 41-60 severe withdrawal, and 61-80 very severe withdrawal. | 13 weeks |
| Anxiety Symptoms | The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5-item self-report measure that can be used to assess severity and impairment associated with any anxiety disorder or multiple anxiety disorders. | 13 weeks |
| Depressive Symptoms | The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. It is used to diagnose depression and grade severity of symptoms in general medical and mental health settings. Scores each of the 9 DSM criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. | 13 weeks |
| Sleep Quality | Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a 9 item self report instrument, designed to measure quality and patterns of sleep from very good to very bad. Sleep quality will also be measured on a daily basis with a mobile phone application. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | 13 weeks |
| Inability to Tolerate Negative States | The Distress Intolerance (DI) Index will be used to assess Inability to tolerate negative states.The index is a 10 item self-report measure designed to assess the inability to tolerate negative states. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score, with higher scores indicating greater DI. | 13 weeks |
| Inflexibility or Experiential Avoidance | The Acceptance and Action Questionnaire-II will be used to measure inflexibility or experiential avoidance. It is a 7 item self-report measure of psychological inflexibility or experiential avoidance. Each of the 7 items can be rated on a scale of 1 (never true) to 7 (always true) so scores can range from 7 to 49. Higher scores equal greater levels of psychological inflexibility. | 13 weeks |
| Fear of Anxiety Symptoms | Fear of anxiety symptoms will be assessed by the Anxiety Sensitivity Index. It is a 16 item scale with each item rated on a five-point Likert scale ranging from 0 (very little) to 4 (very much). Scores can range from 0 to 64. Higher scores reflect greater fear of anxiety symptoms. | 13 weeks |
| Number of Participants Assessed for Distress Tolerance | Distress tolerance will be assessed with the computerized Mirror Tracing Persistence Task (MTPT-C). It is a computerized version of the original Mirror Tracing Persistence Task in which trace multiple progressively difficult polygons, with participants free to terminate at any point. Distress tolerance is measured by the latency in seconds to task termination. | 13 weeks |
| Number of Participants Assessed for Motivations to Use BZD | BZD motivations will be measured using the 12 item BZD Motivation Scale, a self report questionnaire. The questionnaire uses a 4 point Likert scale to assess participant motivations for using BZD, such as managing pain, insomnia, anxiety, and increase high of other illicit drugs. | 13 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-report on drug use in the past 30 days | Count of Participants | Participants |
|
| Urine drug screen | Count of Participants | Participants |
|
| Psychiatric diagnostic interview | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Sexual orientation | Count of Participants | Participants |
|
| Do you have children | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
|
| Ever been prescribed a BZD by a professional | Count of Participants | Participants |
|
| Reason for being prescribed BZD | Count of Participants | Participants |
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| Currently prescribed BZD | Count of Participants | Participants |
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| Ever used BZD without a prescription | Count of Participants | Participants |
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| First source of nonmedical BZD | Count of Participants | Participants |
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| Reason for using nonmedical BZD | Count of Participants | Participants |
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| Ever used nonmedical BZD at least 3 times a week | Count of Participants | Participants |
|
| Used nonmedical BZD in the past 12 months | Count of Participants | Participants |
|
| Frequency of using nonmedical benzodiazepine to relax | Count of Participants | Participants |
|
| Breath holding exercise (in seconds) | Mean | Standard Deviation | seconds |
|
| Pittsburgh Sleep Quality Index rate sleep quality | Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a 9 item self report instrument, designed to measure quality and patterns of sleep from very good to very bad. | Count of Participants | Participants |
|
| How helpful were the information and skill from this session? | Count of Participants | Participants |
|
| How well did you understand the information and skills presented in the session? | Count of Participants | Participants |
|
| Distress Intolerance Index | Distress tolerance will be assessed with the computerized Mirror Tracing Persistence Task (MTPT-C). It is a computerized version of the original Mirror Tracing Persistence Task in which trace multiple progressively difficult polygons, with participants free to terminate at any point. Distress tolerance is measured by the latency in seconds to task termination. | Mean | Standard Deviation | seconds |
|
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| Primary | Number of Participants Who Rates the Intervention as Feasible | Feasibility of intervention will be measured through the number of participants recruited and enrolled in the study, number of participants who started the BZD taper, and completed assessment tools. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
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| Secondary | Completion of Intervention | Completion of intervention will be measured through participant attendance of weekly sessions. Participants must attend all 13 sessions (Baseline, 3 weekly therapy sessions prior to taper, and 8 week BZD taper urine/drug screens). Participants, who miss a study visit, will be considered discontinued from the study if study staff are unable to get in contact with them 7 days after their missed study visit. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | BZD Use Based on Self-report | Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB), adapted for BZD use. The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their BZD use 7 days prior to study visit. We will also monitor BZD use on a daily basis with a mobile phone application. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Illicit Drug Use Based on Urine Drug Tests | Illicit drug use urine tests will screen for amphetamines, benzodiazepines, opiates, oxycodone, fentanyl, cocaine, barbiturates, and methadone. Plus: liquid chromatography-mass spectrometry for clonazepam and lorazepam, and fentanyl if fentanyl test (immunoassay) is positive. | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Alcohol Use Based on Urine Drug Tests | Urine drug tests will include a ethyl glucuronide (EtG) test to detect the presence in the urine of ethyl glucuronide. | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Alcohol Use Based on Self-report | Timeline follow-back will be measured using the 30-day Timeline Followback (TLFB). The Timeline Followback (TLFB) is a clinical and research method to obtain quantitative estimates of drug or alcohol use, and change over time. Participants will be asked to retrospectively estimate their alcohol use 7 days prior to study visit. The alcohol adaption includes estimates of 1 standard drink in terms of beer, wine, and hard liquor. We will also monitor alcohol use on a daily basis with a mobile phone application. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | BZD Withdrawal Symptoms | BZD withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment-Benzodiazepines (CIWA-B). The CIWA-B is a 20 item instrument, to assess severity of benzodiazepine withdrawal, including nausea and vomiting, anxiety, tremor, sweating, auditory disturbances, visual disturbances, tactile disturbances, headache, agitation, and clouding of sensorium. Scores range from 0 to 80, with 1-20 mild withdrawal, 21-40 moderate withdrawal, 41-60 severe withdrawal, and 61-80 very severe withdrawal. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Anxiety Symptoms | The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5-item self-report measure that can be used to assess severity and impairment associated with any anxiety disorder or multiple anxiety disorders. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Depressive Symptoms | The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. It is used to diagnose depression and grade severity of symptoms in general medical and mental health settings. Scores each of the 9 DSM criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Sleep Quality | Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a 9 item self report instrument, designed to measure quality and patterns of sleep from very good to very bad. Sleep quality will also be measured on a daily basis with a mobile phone application. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Inability to Tolerate Negative States | The Distress Intolerance (DI) Index will be used to assess Inability to tolerate negative states.The index is a 10 item self-report measure designed to assess the inability to tolerate negative states. Items are rated from 0 (very little) to 4 (very much) and are summed for a total score, with higher scores indicating greater DI. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | Inflexibility or Experiential Avoidance | The Acceptance and Action Questionnaire-II will be used to measure inflexibility or experiential avoidance. It is a 7 item self-report measure of psychological inflexibility or experiential avoidance. Each of the 7 items can be rated on a scale of 1 (never true) to 7 (always true) so scores can range from 7 to 49. Higher scores equal greater levels of psychological inflexibility. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | Fear of Anxiety Symptoms | Fear of anxiety symptoms will be assessed by the Anxiety Sensitivity Index. It is a 16 item scale with each item rated on a five-point Likert scale ranging from 0 (very little) to 4 (very much). Scores can range from 0 to 64. Higher scores reflect greater fear of anxiety symptoms. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
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| Secondary | Number of Participants Assessed for Distress Tolerance | Distress tolerance will be assessed with the computerized Mirror Tracing Persistence Task (MTPT-C). It is a computerized version of the original Mirror Tracing Persistence Task in which trace multiple progressively difficult polygons, with participants free to terminate at any point. Distress tolerance is measured by the latency in seconds to task termination. | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Number of Participants Assessed for Motivations to Use BZD | BZD motivations will be measured using the 12 item BZD Motivation Scale, a self report questionnaire. The questionnaire uses a 4 point Likert scale to assess participant motivations for using BZD, such as managing pain, insomnia, anxiety, and increase high of other illicit drugs. | 3 out of the 4 participants were lost to follow-up prior to the collection of this primary outcome measure | Posted | Count of Participants | Participants | 13 weeks |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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