A Novel Person-Centered Treatment Component for Substance Use Treatment

December 4, 2013 updated by: Dr. Kathleen Decker, Hampton VA Medical Center

Outcome of a Novel Person-Centered Treatment Component for Substance Use Treatment

A person-centered substance use treatment component, the Natural Recovery Program, was developed in a residential substance use treatment setting. The Natural Recovery Program is comprised of small group therapy combined with pursuit of hobbies. The study examined treatment retention, treatment completion and satisfaction of participants of Natural Recovery compared to those who participated in core residential treatment activities alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

METHODS: Retrospective record review of 643 veterans in an inpatient Mental Health Recovery and Rehabilitation Program was used to determine if participants of Natural Recovery had a different rate of treatment retention and completion than those who participated in the core program alone. Univariate and multivariate analysis was conducted on: participation in the Natural Recovery Program, comorbid psychiatric disorders, legal, medical and psychiatric issues.

PARTICIPANTS: The records of 643 veterans treated in DAP (residential rehabilitation treatment program) at a Veteran's Administration hospital between November, 2009 and March, 2011 were analyzed retrospectively in a quasi-experimental design. The researchers were not blind to participation and participation in the program was an elective component, not randomized. All patients enrolled in DAP were eligible to participate in a novel program called Natural Recovery. Fifteen percent participated in Natural Recovery-Horticulture (n=101), five percent participated in Natural Recovery-Art/Music (n=30) and seventy-nine percent elected to participate in the DAP Core Program only (DAP-CP) (n=512). One percent (n=8) participated in both tracks of Natural Recovery.

PROCEDURE: Participants in Natural Recovery received a one-hour small group therapy session during the week using modules with a staff facilitator while DAP-CP participants attended a large psychoeducational group at that time. Participants in Natural Recovery were given a choice of tracks, either Horticulture or Art/Music based on personal preference. The modules employ analogies between the recovery process and their chosen hobby. Although hobbies were different between the two tracks of Natural Recovery, the fourteen modules covered the same concepts; only the analogy portion of each handout differed.

Natural Recovery participants also pursued four hours of their hobby on each weekend day while DAP-CP participants received large group psychoeducational lectures on weekends during the same amount of time. Thus, total substance use treatment hours between Natural Recovery participants and DAP core program (DAP-CP) participants were equivalent. Additionally, all Natural Recovery-Art/Music, Natural Recovery-Horticulture and DAP-CP participants received one "Leisure Education" lecture.

All participants were free to pursue hobbies during treatment but Natural Recovery participants received materials (access to gardening tools and gardening zones, were provided musical instruments and/or art supplies) to pursue their choice of hobby on the weekend. DAP-CP participants could pursue hobbies during treatment but were not provided musical instruments or art materials, nor did they have access to gardening tools to work in the garden although they could walk in it.

MATERIALS: The modules of Natural Recovery have been previously published and constitute 14 topics, each of which is discussed weekly for 14 weeks [33]. Participants could repeat Natural Recovery modules if their length of stay exceeded 14 weeks. The total number of modules was recorded for each participant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
643

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Hampton, Virginia, United States, 23667
        • Hampton VAMC, Department of Mental Health & Behavioral Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients enrolled in the residential substance use treatment program

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: DAP-CP
512 patients who elected to participate in the Drug Abuse Core Program alone (DAP-CP).
Experimental: Natural Recovery-Horticulture
Participants in Natural Recovery-Horticulture received a one-hour small group therapy session during the week using one module per week with a staff facilitator and also pursued four hours of their hobby on each weekend day for up to 14 weeks.
Behavioral: Natural Recovery-Horticulture

Participants in Natural Recovery-Horticulture received a one-hour small group therapy session during the week using Horticulture modules with a staff facilitator while DAP-CP participants attended a large psychoeducational group at that time.

Natural Recovery participants also pursued four hours of gardening on each weekend day while DAP-CP attended large-group lectures.
Experimental: Natural Recovery-Art/Music
Participants in Natural Recovery-Art/Music received a one-hour small group therapy session during the week using one module per week with a staff facilitator and also pursued four hours of their hobby on each weekend day for up to 14 weeks.
Behavioral: Natural Recovery-Art/Music
Participants in Natural Recovery-Art/Music received a one-hour small group therapy session during the week using Art/Music modules with a staff facilitator while DAP-CP participants attended a large psychoeducational group at that time. Natural Recovery participants also pursued four hours of art or music on each weekend day while DAP-CP attended large-group lectures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Completion
Time Frame: Up to 150 days
Treatment completion was defined as regular discharge from the program, which was between 1 and 150 days.
Up to 150 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Retention
Time Frame: up to 150 days
Treatment retention was defined as the number of days in treatment, from 1-150 days.
up to 150 days
Satisfaction with program
Time Frame: up to 150 days
Satisfaction with either DAP-CP, Natural Recovery-Horticulture or Natural Recovery-Art/Music was measured at the time of discharge on a Likert scale of 1-5 where 5 was highest.
up to 150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hampton VA Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathleen Decker, MD, Hampton VAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Decker, KP: Natural Recovery Program. In Mental Health Residential Rehabilitation Treatment Program (MH RRTP) Promising Practices Compendium: Improving Veterans' Mental Health Care for the 21st Century, Edited by Angela Gerolamo, Jennifer McGovern, Amy Krilla Overcash, Kester St. Kitts, Nikkilyn Morrison, Grace Roemer. Mathematica Policy Research; 2011: p. 24 and p. 184-222.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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