Trial Outcomes & Findings for Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention (NCT NCT04261504)

Last Updated: 2024-05-29

Results Overview

70 participants with polysubstance use are assessed by changes of brain in functional activity of anterior cingulate cortex before (baseline) and post-intervention (2 weeks).

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

The outcome measure is assessed at baseline and post-intervention.

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Integrative Body Mind Training (IBMT) mindfulness IBMT: mindful presence in a non-judgmental way	Relaxation Training (RT) relaxation RT: progressive muscle relaxation
Overall Study STARTED	35	35
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Integrative Body Mind Training (IBMT) n=35 Participants mindfulness IBMT: mindful presence in a non-judgmental way	Relaxation Training (RT) n=35 Participants relaxation RT: progressive muscle relaxation	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=93 Participants	35 Participants n=4 Participants	70 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	18 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Unknown/Not Reported Ethnicity	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: The outcome measure is assessed at baseline and post-intervention.

70 participants with polysubstance use are assessed by changes of brain in functional activity of anterior cingulate cortex before (baseline) and post-intervention (2 weeks).

Outcome measures

Outcome measures
Measure	Integrative Body Mind Training (IBMT) n=30 Participants mindfulness IBMT: mindful presence in a non-judgmental way	Relaxation Training (RT) n=28 Participants relaxation RT: progressive muscle relaxation
Brain Changes in Functional Activity Baseline	0.7 beta weights Standard Deviation 1.2	0.6 beta weights Standard Deviation 1.3
Brain Changes in Functional Activity Post-Intervention	1.3 beta weights Standard Deviation 1.1	0.9 beta weights Standard Deviation 2.2

Adverse Events

Integrative Body Mind Training (IBMT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relaxation Training (RT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yi-Yuan Tang

Arizona State University

Phone: 4807903577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place