Substance Use DisordersNCT02005367
A Novel Person-Centered Treatment Component for Substance Use Treatment
A study testing Natural Recovery-Horticulture and Natural Recovery-Art/Music in people with Substance Use Disorders and Depression, run by Hampton VA Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Substance Use Disorders, Depression, Bipolar Disorder
- What is being tested?
- Natural Recovery-Horticulture and Natural Recovery-Art/Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients enrolled in the residential substance use treatment program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Hampton VAMC, Department of Mental Health & Behavioral Sciences
Hampton, Virginia, 23667
About this study
Official title: 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.
Read the 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.
- Being tested
- Natural Recovery-Horticulture, Natural Recovery-Art/Music
- Keywords
- substance use treatment, person-centered treatment, residential treatment outcomes, dual diagnosis, recovery model, psychosocial treatment
- Medical subject headings
- Substance-Related Disorders, Depression, Bipolar Disorder, Psychotic Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Recovery-HorticultureBehavioural
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.
Natural Recovery-Art/MusicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DAP-CP | No intervention | 512 patients who elected to participate in the Drug Abuse Core Program alone (DAP-CP). |
| Natural Recovery-Horticulture | Experimental | 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. Receives: Behavioral: Natural Recovery-Horticulture |
| Natural Recovery-Art/Music | Experimental | 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. Receives: Behavioral: Natural Recovery-Art/Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion
Treatment completion was defined as regular discharge from the program, which was between 1 and 150 days.
Measured: Up to 150 days
Secondary outcomes (2)
Treatment Retention
Treatment retention was defined as the number of days in treatment, from 1-150 days.
Measured: up to 150 days
Satisfaction with program
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.
Measured: up to 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hampton VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Kathleen Decker, Hampton VA Medical Center
- Investigators
- Kathleen Decker, MD, Principal investigator, Hampton VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005367
- Sponsor's protocol ID
- 2013-001
- Status last verified
- Dec 2013
- First submitted
- 26 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of a Novel Person-Centered Treatment Component for Substance Use Treatment
- ClinicalTrials.gov ID
- NCT02005367
- Acronym / sponsor ID
- 2013-001
- Keywords
- substance use treatment, person-centered treatment, residential treatment outcomes, dual diagnosis, recovery model, psychosocial treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Hampton VA Medical CenterUS federal agency
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAP-CP | No intervention | –512 patients who elected to participate in the Drug Abuse Core Program alone (DAP-CP). |
| Natural Recovery-Horticulture | Experimental | Behavioral: Natural Recovery-HorticultureParticipants 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. |
| Natural Recovery-Art/Music | Experimental | Behavioral: Natural Recovery-Art/MusicParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients enrolled in the residential substance use treatment program
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Recovery-HorticultureParticipants 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. | Behavioural | Natural Recovery-Horticulture |
| Natural Recovery-Art/MusicParticipants 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. | Behavioural | Natural Recovery-Art/Music |
Primary outcome
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.
2 secondary outcomes
Treatment Retention
Time frame: up to 150 days
Satisfaction with program
Time frame: up to 150 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- BackgroundDecker, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Decker, MD principal investigator
Hampton VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Recovery-Horticulture and Natural Recovery-Art/Music in people with Substance Use Disorders and Depression, run by Hampton VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Completion (time frame: Up to 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02005367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.