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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50DA009241-21 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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We are proposing a small randomized clinical trial in which 100 substance users will complete the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well as a novel battery of assays to evaluate cognitive-affective functioning. After completing pretreatment assessments, participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per week for 4 weeks, after which assessment batteries will be repeated. Finally, we will evaluate real-world behavior and the durability of the training via a one-month follow-up, which will include assessment of substance use as well as the cognitive-affective battery.
Participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non- methadone/buprenorphine) treatment for any substance use disorder (other than PCP) at the Substance Abuse Treatment Unit in New Haven. As the goal of this project is to develop interventions that address self-regulation across multiple disorders, we will recruit individuals who have a range of substance use disorders and levels of severity. Our primary Specific Aim will be to evaluate the efficacy of the cognitive-remediation program relative to the control condition control on the indicators of cognitive-affective functioning and substance use, testing the hypothesis that individuals randomized to the cognitive remediation program will demonstrate improved functioning on the cognitive-affective battery as well as reduced real-world substance abuse. We will also explore potential moderators of response to the training, including baseline measures of cognitive-affective function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU plus Cognitive Remediation Program | Experimental | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making. |
|
| TAU plus Control Tasks | Placebo Comparator | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAU plus Cognitive Remediation Program | Behavioral | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stop Signal Reaction Time | Improved functioning on cognitive-affective battery: Examining Stop Signal reaction time changed across the 4-week training period. A change score was calculated. A negative number indicates better inhibition over time. | Training visit 1 through 4 weeks of training |
| Change From Pre-Post in Substance Use | The cube root of the number of days the participant endorsed using their primary substance. The number of days was submitted to a cube root transformation given skewness and a change score was calculated (post minus pre). A negative number indicated decreased substance use over time. | 4 weeks before First Training Session through the 4-week training period |
| Change in Pre-Post Cognitive Affective Battery- Negative Urgency Subscale (Part of the Urgency, Premeditation (Lack of), Perseverance (Lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale) | Negative urgency (NU) subscale. The scale score range is 11-44. Higher values indicate stronger agreement with this pathway toward impulsivity. A change score was calculated. A negative number indicates less agreement with negative urgency. | from the week prior to training to the week after training |
| Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task | The percent of risky choices per session. This would indicate that the participant selected the lottery option that reflected a riskier bet. A change score was calculated. A negative number indicates improved decision-making (selecting fewer risky options). | Training visit 1 through 4 weeks of training |
| Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Baskin-Sommers, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Abuse Treatment Center (SATU) | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAU Plus Cognitive Remediation Program | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making. TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes. |
| FG001 | TAU Plus Control Tasks | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TAU Plus Cognitive Remediation Program | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making. TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes. |
| 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, Categorical | Count of Participants |
| 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 | Change in Stop Signal Reaction Time | Improved functioning on cognitive-affective battery: Examining Stop Signal reaction time changed across the 4-week training period. A change score was calculated. A negative number indicates better inhibition over time. | All participants who completed one or more sessions of the computerized Stop Signal task. Negative change reflects improved inhibition over time. | Posted | Mean | Standard Error | ms | Training visit 1 through 4 weeks of training |
|
2 months
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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 | TAU Plus Cognitive Remediation Program | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making. TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arielle Baskin-Sommers | Yale University | 203-432-9257 | arielle.baskin-sommers@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2017 | Nov 3, 2020 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2019 | Nov 3, 2020 | ICF_004.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 22, 2019 | Nov 3, 2020 | Prot_005.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks).
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| TAU plus Control Tasks | Behavioral | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. |
|
Percent of choices the participant made that reflected selecting the ambiguous option.
A change score was calculated. A negative number reflects improved decision-making (selecting more safe options).
| Training visit 1 through 4 weeks of training |
| Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT) | Estimated change in percentage of trial attempts on round 3 of the PASAT. A positive number reflects more trial attempts in the third round of PASAT. | from the week prior to training (pre) to the week after training (post) |
| Change in Pre-Post Cognitive Affective Battery: Digit Backwards | Score on digit backwards. Fourteen strings of varying lengths (2 to 7 digits) are presented. A participant receives a point for each string they correctly repeat backwards. Range 0-14 points. Change score was calculated-positive values indicate improved working memory over time. | from the week prior to training (pre) to the week after training (post) |
| Change in Pre-Post Cognitive Affective Battery: Breath Holding | Negative emotionality-distress tolerance as measured by the difference between when the participant says they are uncomfortable and when they let go of holding their breath. Measured in seconds (this was natural log-transformed due to skewness for analyses). Positive change indicates improved distress tolerance over time. | from the week prior to training (pre) to the week after training (post) |
| Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale | Negative emotionality-perceived stress. The total score ranges from 0-4. Higher scores indicate a higher level of perceived stress. A change score was calculated. Negative change indicates an improvement (reduction in perceived stress) over time. | from the week prior to training (pre) to the week after training (post) |
| Change in Pre-Post Cognitive Affective Battery: Delay Discounting | Incentive salience- delay discounting. Five-Trial Adjusting-Delay Discounting Task (Koffarnus & Bickel, 2014) is a 5-item behavioral assessment used to estimate the extent to which individuals prefer smaller immediate rewards over larger delayed rewards. A discount rate (ln (k)) is calculated for each time the measure is used. Discount rates for the 5- trial delay task were calculated by taking the inverse of the obtained Effective Delay 50 value, which is equivalent to the value of k, when fitted to this singular point. Ln(k) is the natural log of the discount rate. A change score was calculated. Negative change indicates improved decision-making | from the week prior to training (pre) to the week after training (post) |
| BG001 | TAU Plus Control Tasks | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| 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 |
|
| OG001 | TAU Plus Control Tasks | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. |
|
|
|
| Primary | Change From Pre-Post in Substance Use | The cube root of the number of days the participant endorsed using their primary substance. The number of days was submitted to a cube root transformation given skewness and a change score was calculated (post minus pre). A negative number indicated decreased substance use over time. | All participants who completed the pre- and post-treatment substance use calendar. | Posted | Mean | Standard Error | cube root (number of days) | 4 weeks before First Training Session through the 4-week training period |
|
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| Primary | Change in Pre-Post Cognitive Affective Battery- Negative Urgency Subscale (Part of the Urgency, Premeditation (Lack of), Perseverance (Lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale) | Negative urgency (NU) subscale. The scale score range is 11-44. Higher values indicate stronger agreement with this pathway toward impulsivity. A change score was calculated. A negative number indicates less agreement with negative urgency. | All participants who completed the UPPS-NU for both pre- and post-treatment cognitive-affective battery | Posted | Mean | Standard Error | score on scale | from the week prior to training to the week after training |
|
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|
|
| Primary | Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task | The percent of risky choices per session. This would indicate that the participant selected the lottery option that reflected a riskier bet. A change score was calculated. A negative number indicates improved decision-making (selecting fewer risky options). | All participants who completed one or more sessions of the Lottery Task. Negative change indicated improved decision-making | Posted | Mean | Standard Error | percent of risky choices | Training visit 1 through 4 weeks of training |
|
|
|
|
| Primary | Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task | Percent of choices the participant made that reflected selecting the ambiguous option. A change score was calculated. A negative number reflects improved decision-making (selecting more safe options). | All participants who completed one or more sessions of the computerized Lottery task. Negative change reflects improved decision-making. | Posted | Mean | Standard Error | percent of ambiguous choices | Training visit 1 through 4 weeks of training |
|
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| Primary | Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT) | Estimated change in percentage of trial attempts on round 3 of the PASAT. A positive number reflects more trial attempts in the third round of PASAT. | All participants who completed one or more sessions of the computerized PASAT. Positive change reflects improved cognitive-affective functioning (distress tolerance) over time. | Posted | Mean | Standard Error | percentage of trials attempted | from the week prior to training (pre) to the week after training (post) |
|
|
|
|
| Primary | Change in Pre-Post Cognitive Affective Battery: Digit Backwards | Score on digit backwards. Fourteen strings of varying lengths (2 to 7 digits) are presented. A participant receives a point for each string they correctly repeat backwards. Range 0-14 points. Change score was calculated-positive values indicate improved working memory over time. | All participants who completed the digit backwards for both pre- and post-treatment cognitive-affective battery | Posted | Mean | Standard Error | scores on scale | from the week prior to training (pre) to the week after training (post) |
|
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|
| Primary | Change in Pre-Post Cognitive Affective Battery: Breath Holding | Negative emotionality-distress tolerance as measured by the difference between when the participant says they are uncomfortable and when they let go of holding their breath. Measured in seconds (this was natural log-transformed due to skewness for analyses). Positive change indicates improved distress tolerance over time. | All participants who completed the breath holding task for both pre- and post-treatment cognitive-affective battery | Posted | Mean | Standard Error | ln(seconds) | from the week prior to training (pre) to the week after training (post) |
|
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| Primary | Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale | Negative emotionality-perceived stress. The total score ranges from 0-4. Higher scores indicate a higher level of perceived stress. A change score was calculated. Negative change indicates an improvement (reduction in perceived stress) over time. | All participants who completed the perceived stress scale (PSS) for both pre- and post-treatment cognitive-affective battery | Posted | Mean | Standard Error | scores on scale | from the week prior to training (pre) to the week after training (post) |
|
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|
|
| Primary | Change in Pre-Post Cognitive Affective Battery: Delay Discounting | Incentive salience- delay discounting. Five-Trial Adjusting-Delay Discounting Task (Koffarnus & Bickel, 2014) is a 5-item behavioral assessment used to estimate the extent to which individuals prefer smaller immediate rewards over larger delayed rewards. A discount rate (ln (k)) is calculated for each time the measure is used. Discount rates for the 5- trial delay task were calculated by taking the inverse of the obtained Effective Delay 50 value, which is equivalent to the value of k, when fitted to this singular point. Ln(k) is the natural log of the discount rate. A change score was calculated. Negative change indicates improved decision-making | All participants who completed the delay discounting task for both pre- and post-treatment cognitive-affective battery | Posted | Mean | Standard Error | ln(k) | from the week prior to training (pre) to the week after training (post) |
|
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|
|
| 0 |
| 22 |
| 2 |
| 22 |
| 0 |
| 22 |
| EG001 | TAU Plus Control Tasks | Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games. | 0 | 24 | 1 | 24 | 0 | 24 |
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
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