NCT01751542

Brief Summary

Randomized clinical trial comparing standard residential substance abuse treatment to standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance use.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

December 13, 2012

Last Update Submit

December 13, 2012

Conditions

Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Substance use after discharge from treatment

    6 months

Study Arms (2)

Mindfulness + residential treatment

EXPERIMENTAL

Mindfulness and Acceptance Group Therapy + residential treatment

Behavioral: Mindfulness + Residential Treatment

Residential Treatment

ACTIVE COMPARATOR

Residential treatment alone

Behavioral: Residential treatment alone

Interventions

Mindfulness + Residential TreatmentBEHAVIORAL
Mindfulness + residential treatment
Residential treatment aloneBEHAVIORAL
Residential Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participating in inpatient substance use treatment at treatment facility

You may not qualify if:

  • psychosis and mental impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tenneessee & Cornerstone of Recovery

Knoxville, Tennessee, 37996, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

MindfulnessResidential Treatment

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioenvironmental Therapy

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 18, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

US(1)