Trial Outcomes & Findings for Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment (NCT NCT03894501)
NCT ID: NCT03894501
Last Updated: 2022-01-11
Results Overview
The number of individuals who express interest in the study.
COMPLETED
NA
30 participants
Baseline
2022-01-11
Participant Flow
Participant milestones
| Measure |
Mindfulness Oriented Recovery Enhancement
The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
Baseline characteristics by cohort
| Measure |
Mindfulness Oriented Recovery Enhancement
n=15 Participants
The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Days of Illicit Drug Use
|
24.0 days
STANDARD_DEVIATION 17.4 • n=5 Participants
|
25.2 days
STANDARD_DEVIATION 29.3 • n=7 Participants
|
24.6 days
STANDARD_DEVIATION 23.7 • n=5 Participants
|
|
Days of Illicit Opioid Use
|
6.4 days
STANDARD_DEVIATION 9.2 • n=5 Participants
|
11.7 days
STANDARD_DEVIATION 12.8 • n=7 Participants
|
9.1 days
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Pain Level
|
28.3 score on a scale
STANDARD_DEVIATION 27.6 • n=5 Participants
|
37.5 score on a scale
STANDARD_DEVIATION 23.5 • n=7 Participants
|
32.9 score on a scale
STANDARD_DEVIATION 25.6 • n=5 Participants
|
|
Depression Level
|
27.2 score on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
23.5 score on a scale
STANDARD_DEVIATION 13.4 • n=7 Participants
|
25.4 score on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Anxiety Level.
|
41.7 score on a scale
STANDARD_DEVIATION 14.5 • n=5 Participants
|
39.7 score on a scale
STANDARD_DEVIATION 12.3 • n=7 Participants
|
40.7 score on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Methadone clinic clients.
The number of individuals who express interest in the study.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Study Interest
|
32 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Individuals who expressed interest in the study.
The number of individuals who who refuse participation when offered.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Study Refusal
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (study enrollment)Population: Individuals screened for eligibility.
The number of individuals screened and eligible/ineligible.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Individuals Screened
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (study enrollment)Population: Eligible individuals.
The number of individuals consented.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=32 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Individuals Consented.
|
31 Participants
|
—
|
PRIMARY outcome
Timeframe: EnrollmentPopulation: Individuals who participated in consent process.
The number of individuals who refuse participation after/during consent process.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=31 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Refusal After/During Consent Process.
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At 8-weeks (post treatment period completion).Population: Participants randomized to receive the MORE intervention.
The mean number of sessions completed by study participants in the MORE intervention.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Mean Sessions Completed
|
6.4 number of sessions
Standard Deviation 3.9
|
—
|
PRIMARY outcome
Timeframe: At 8-weeks (post treatment period completion).Population: Participants randomized to MORE
The mean percentage of sessions completed by study participants randomized to MORE.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Percentage of Sessions Completed
|
76 percentage of sessions
Standard Deviation .20
|
—
|
PRIMARY outcome
Timeframe: At 16 weeks.Population: Participants enrolled and randomized.
Number of participants who drop out of the study.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Number Who Drop Out
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At 16 weeks.Population: Participants enrolled and randomized.
Percentage of participants who drop out of the study.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Percentage Who Drop Out
|
0 percentage of particpants
|
—
|
PRIMARY outcome
Timeframe: At baseline,Population: All randomized participants.
The number of participants who complete baseline assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Baselines Completed
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: At baseline,Population: All randomized participants.
Percentage of people who completed baseline assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Percentage Baselines Completed
|
100 percentage of baseline assessments
|
—
|
PRIMARY outcome
Timeframe: At 8-weeks.Population: All participants randomized.
The number of participants who complete 8-week assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
8-weeks Completed
|
30 Participants
|
—
|
PRIMARY outcome
Timeframe: At 8-weeks.Population: All randomized participants.
Percentage of participants who completed 8-week assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Percentage 8-Weeks Completed
|
100 percentage of 8-week assessments.
|
—
|
PRIMARY outcome
Timeframe: At 16-weeks.Population: All randomized participants.
The number of participants who completed 16-week assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
16-Weeks Completed
|
29 Participants
|
—
|
PRIMARY outcome
Timeframe: At 16-weeks.Population: All randomized participants.
Percentage of participants who completed 16-week assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=30 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Percentage of 16-Weeks Completed
|
96.7 percentage of 16-week assessments.
|
—
|
SECONDARY outcome
Timeframe: 16-weeksPopulation: All individuals randomized.
Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit drug use" was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Days of Illicit Drug Use
|
6.37 days
Standard Deviation 2.76
|
15.56 days
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: 16-weeksResearch staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. "Days of illicit opioid use" was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Days of Illicit Opioid Use
|
2.47 days
Standard Deviation .97
|
5.49 days
Standard Deviation .97
|
SECONDARY outcome
Timeframe: 16-weeksResearch staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Opioid Craving
|
15.52 score on a scale
Standard Deviation 1.71
|
21.35 score on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 16-weeksPopulation: All randomized participants.
Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Pain Level.
|
50.76 score on a scale
Standard Deviation 5.52
|
26.65 score on a scale
Standard Deviation 5.54
|
SECONDARY outcome
Timeframe: 16-weeksDepression was measured with Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a widely used valid and reliable measure that consists of 20 items with potential scores ranging from 0 to 60. A score above 16 on the CES-D indicates clinically significant symptoms of depression. Higher scores on the CES-D indicates greater depression.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Depression Level.
|
34.11 score on a scale
Standard Deviation 2.31
|
42.93 score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: 16-weeksPopulation: All randomized participants.
Anxiety was measured with the Beck Anxiety Inventory (BAI). The BAI is also a widely used, reliable, and valid scale that consists of 21 items with potential scores ranging from 0 to 63. A score of 16 or higher indicates clinically sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety.
Outcome measures
| Measure |
Participants Who Expressed Interest in the Study
n=15 Participants
Individuals who asked for information on the study or who asked to be screened for eligibility.
|
Methadone Program Behavioral Treatment as Usual
n=15 Participants
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
|
|---|---|---|
|
Anxiety Level.
|
41.05 score on a scale
Standard Deviation 3.09
|
50.83 score on a scale
Standard Deviation 3.09
|
Adverse Events
Mindfulness Oriented Recovery Enhancement
Methadone Program Behavioral Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nina Cooperman
Rutgers Robert Wood Johnson Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place