Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Baseline Cortisol Reactivity to Drug Cues |
Non-invasive salivary cortisol levels were assessed as a measure of stress reactivity to drug cues at baseline. A saliva sample was collected at baseline and again 20 minutes after watching a video depicting drug use. Saliva samples were assayed for cortisol levels. Cortisol reactivity for each participant was calculated using a difference score in which the baseline sample cortisol level was subtracted from the post-video sample cortisol level. |
at baseline data collection |
|
| Primary |
Number of Days Adherence to Medication Assisted Treatment |
The primary outcome variable is adherence to medication-assisted therapy (MAT), quantified as the number of days MAT was received as indicated during the last 4 weeks of the intervention period. We expect that this can be treated as a continuous variable in regression models. |
Last 4 weeks of the intervention period |
|
| Secondary |
Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate |
Retention rate (the number of participants completing T4 divided by the number who were randomized for each treatment arm) |
12 months |
|
| Secondary |
Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale |
Scores on the TAAS are scored on a scale of 1-7. For ease of interpretation by our participants and for data entry purposes, we asked participants to rate the experience on a scale of 1-10. The composite sum score was used for each person. Therefore, scores ranged from 10 to 100. Higher numbers mean more treatment acceptability and adherence |
3 months - at the end of the 12 week intervention |
|
| Secondary |
Satisfaction With the Intervention Program |
Satisfaction with the intervention program will be assessed with the 8-item Client Satisfaction Questionnaire (CSQ-8). The total score will be computed by adding the 8 items for a composite score. The range for composite scores is from 8-32. Higher numbers mean more satisfied the participant is with the program. |
3 months - at the end of the 12 week intervention |
|
| Secondary |
Acceptability of the Intervention Programs |
Exit interviews were conducted with all participants to determine whether participants rated the intervention as acceptable. The number who rated each intervention as acceptable is reported. |
3 months |
|
| Secondary |
Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen |
Relapse will be measured during the last 4 weeks of the intervention period as determined by Urine Drug Screen (UDS). Participants were only considered relapsed if they had opiates (outside prescribed MOUD) or any other illicit substance detected in the urine drug screen during the last four weeks of the 12-week intervention. |
Last four weeks of the 12-week intervention |
|
| Secondary |
Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report |
Relapse will be measured via self-report utilizing the Timeline Follow-back (TLFB). The total number of participants who self-reported relapse during the last four weeks of the intervention period per treatment arm. |
3 months |
|
| Secondary |
Opioid Cravings as Measured by the Opioid Craving Scale |
Cravings as measured by the Opioid Craving Scale (OCS), a modification of the Cocaine Craving Scale will be utilized to assess opioid craving. The OCS consists of three items rated on a visual analog scale from 0-10. The total score is calculated by averaging the three items. Higher means scores represent more craving. |
6 months |
|
| Secondary |
Social Support as Measured by the Community Assessment Inventory |
Social Support as measured by the Community Assessment Inventory (CAI) to assess perceived support. The original CAI contains 37 items covering support within four areas i.e., family living with and outside, friends, and communities, with items in each area summed to create the corresponding subscales. Lower scores indicate less support and higher scores indicate greater support. We will only evaluate community support for the current study (containing 13 items). Therefore, scores ranged from 13 to 52. |
6 months |
|
| Secondary |
Depression as Measured by the Patient Health Questionnaire |
Depression as measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report that measures depressive symptoms. The participant's score may range from 1- 27. The interpretation of the total score is as follows: 1-4, Minimal depression; 5-9, mild depression; 10-14, Moderate depression; 15-19, Moderately severe depression; 20-27, Severe depression. Higher numbers mean more depressive symptoms at 12 weeks post-end of intervention. |
6 months |
|
| Secondary |
Stress as Measured by the Perceived Stress Scale |
Stress as measured by the Perceived Stress Scale (PSS), a 10-item self-report of perceived stress. Scores may range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14 to 26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
6 months |
|
| Secondary |
Anxiety as Measured by the Generalized Anxiety Disorder Scale |
Anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report of anxiety. The score for the seven items ranges from 0 to 21. Scores of 5-9 represent mild anxiety, 10- 14 represent Moderate anxiety, and scores greater than 15 represent severe anxiety. Higher numbers indicate higher anxiety at 12 weeks post-end of intervention. |
6 months |
|
| Secondary |
Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate |
Randomization rate (the number of participants randomized divided by the number of participants who consented). Participants consented to hear about the study before screening for eligibility was conducted. This was based on how our protocol was written. Therefore, some of the people who consented did not end up meeting the eligibility criteria for the study, and therefore were not considered enrolled in the study. The difference between consented participants and the enrolled participants is due to the screen failures. Participants are also only considered randomized after they complete all baseline data collection, including providing biosamples. We have revised this protocol for the R33 phase to avoid the issue of screen failures after the consent process is completed. |
12 months |
|
| Secondary |
Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate |
Enrollment rate (the number of participants who sign the informed consent form divided by the number who are approached). Participants consented to hear about the study before screening for eligibility was conducted. This was based on how our protocol was written. Therefore, some of the people who consented did not end up meeting the eligibility criteria for the study, and therefore were not considered enrolled in the study. The difference between consented participants and the enrolled participants is due to the screen failures. Participants are also only considered randomized after they complete all baseline data collection, including providing biosamples. We have revised this protocol for the R33 phase to avoid the issue of screen failures after the consent process is completed. |
12 months |
|
