Substance-Related DisordersPhase 2NCT00086398
Psychotherapy Enhancement for Therapeutic Community (TC) Retention - 1
A Phase 2 study testing Behavior Therapy in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to not given
- Phase
- Phase 2
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak English
Who cannot join
- Acute suicidality, homicidality, psychosis, mania
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
APT Residential Services Division
New Haven, Connecticut, 06519
Lisa Maccarelli, Ph.D., 203-337-9943 ext. 210, lisa.maccarelli@yale.edu
About this study
Official title: Psychotherapy Enhancement for TC Retention
The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents.
Read the detailed description
Therapeutic Community (TC) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. Personality disorders are very common in residential programs, and TCs regard personality disturbance as core to all people with addiction. Severe personality dysfunction is associated with higher dropout rates from TCs, and adding cognitive-behavioral treatments may improve retention and outcome. We hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of TC processes and techniques. We predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach.
To begin to improve retention, TC research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. We have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 TC residents. In addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the TC.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Psychosocial functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2004 (estimated)
- Study startSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related 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 2
- Primary purpose
- Treatment
- Intervention model
- Factorial
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Samuel Ball, Ph.D., Principal investigator, APT Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086398
- Sponsor's protocol ID
- NIDA-14967-1
- Other IDs
- R01-14967-1
- Status last verified
- Nov 2005
- First submitted
- 1 Jul 2004
- Last updated
- 7 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy Enhancement for TC Retention
- ClinicalTrials.gov ID
- NCT00086398
- Acronym / sponsor ID
- NIDA-14967-1
- Conditions
- Substance-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2001
- First posted
- 7 Jul 2004 (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.
The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents.
Detailed description
Therapeutic Community (TC) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. Personality disorders are very common in residential programs, and TCs regard personality disturbance as core to all people with addiction. Severe personality dysfunction is associated with higher dropout rates from TCs, and adding cognitive-behavioral treatments may improve retention and outcome. We hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of TC processes and techniques. We predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach.
To begin to improve retention, TC research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. We have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 TC residents. In addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the TC.
Study design
- Primary purpose
- Treatment
- Intervention model
- Factorial
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak English
Key exclusion criteria (1 listed)
- Acute suicidality, homicidality, psychosis, mania
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Retention
Psychosocial functioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2005.
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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.
Samuel Ball, Ph.D. principal investigator
APT Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavior Therapy in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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: status not confirmed, as of the sponsor's last update on 7 Nov 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Ball, Ph.D. ((203)937-3486, samuel.ball@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2005.