Substance AbuseNCT00606996
Group Therapy for Women Prisoners With Comorbid Substance Use and Depression
A study testing Group interpersonal psychotherapy (IPT-G) and Psychoeducation on co-occurring disorders (PSYCHOED) in people with Substance Abuse and Substance Dependence, run by Brown University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Substance Abuse, Substance Dependence, Depressive Disorder
- What is being tested?
- Group interpersonal psychotherapy (IPT-G) and Psychoeducation on co-occurring disorders (PSYCHOED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2009
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are recruited from prison substance use treatment programs.
- Current primary (non-substance-induced, as defined by the SCID) depressive disorder (major depressive or dysthymic disorder) after at least 4 weeks of prison SUD treatment and abstinence.
- A minimum Hamilton Depression score of 18 or higher, indicating moderate to severe depression.
- Depressive disorder at any time while not incarcerated.
- Substance use disorder one month prior to incarceration.
- Between 10 and 18 weeks away from release from prison.
Who cannot join
- Lifetime criteria for bipolar disorder
- Lifetime criteria for a psychotic disorder
- Actively suicidal
Trial locations and contacts
1 site in 1 country.
United States1 site
Adult Correctional Institution
Cranston, Rhode Island, 02920
About this study
Official title: Group IPT for Women Prisoners With Comorbid Substance Use and Depression
The purpose of the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners.
Read the detailed description
Incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates of both substance use disorder (SUD; abuse or dependence on alcohol, illegal drugs, or prescription drugs; 70%) and depressive disorder (DD; major depressive disorder and dysthymic disorder; 20-27%). DDs tend to worsen the course of SUDs for incarcerated women by increasing their risk for suicide attempts, contributing to the persistence of substance abuse, and reducing the likelihood of a successful transition to an independent, sober life in the community. Recent evidence indicates that DDs are common in persons with SUDs, often do not remit with SUD treatment, and should be treated. Despite growing recognition that co-occurring disorders, such as DDs, among substance abusing incarcerated women present an important public health concern, integrated treatments for SUD-DD have not been well-developed for or systematically tested in this population. Group Interpersonal Psychotherapy (IPT-G) has been shown to be efficacious in treating DD in other populations and may be especially pertinent to the needs of incarcerated women with SUD-DD because interpersonal difficulties not only affect severity of depression, but are also strong predictors of drinking to cope, SUD relapse, and prison recidivism in women.
This study tests the hypotheses that as adjuncts to prison SUD treatment, IPT-G, relative to psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for:
- Reduction in the risk and severity of substance use relapse after release from prison
- Recovery from depressive disorder and reduction in depressive symptoms
- Improvement in social support and interpersonal functioning
- Reduction in the severity of legal problems during the 3 month follow-up period
- Conditions
- Substance Abuse, Substance Dependence, Depressive Disorder
- Being tested
- Group interpersonal psychotherapy (IPT-G), Psychoeducation on co-occurring disorders (PSYCHOED)
- Keywords
- Drug Abuse, Drug Dependence, Alcohol Abuse, Alcohol Dependence, Major Depressive Disorder, Dysthymic Disorder, Prisoners, Women
- Medical subject headings
- Substance-Related Disorders, Depressive Disorder, Alcoholism, Depressive Disorder, Major, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interpersonal psychotherapy (IPT-G)Behavioural
Psychoeducation on co-occurring disorders (PSYCHOED)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| IPT-G | Experimental | Group Interpersonal Psychotherapy Receives: Behavioral: Group interpersonal psychotherapy (IPT-G) |
| PSYCHOED | Active comparator | Psychoeducation Receives: Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance-free days after release from prison, measured by the Timeline Followback method
Measured: 3 months post-release
Severity of substance use after release from prison, measured by the Addiction Severity Index
Measured: 3 months post-release
Verification of substance-free status using breath alcohol tests and urine drug screens
Measured: 3 months post-release
Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
Measured: Pre-release
Depression symptom severity measured by the Beck Depression Inventory
Measured: Pre-release
Secondary outcomes (6)
Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index
Measured: 3 months post-release
Interpersonal problems, measured by the Inventory of Interpersonal Problems
Measured: 3 months post-release
Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment
Measured: 3 months post-release
Perceived social support measured by the Multidimensional Scale of Perceived Social Support
Measured: 3 months post-release
Social support for recovery, measured by the Important People and Activities scale
Measured: 3 months post-release
Social functioning, measured by the Social Adjustment Scale
Measured: 3 months post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jennifer Johnson, Brown University
- Investigators
- Jennifer E. Johnson, Ph.D., Principal investigator, Department of Psychiatry and Human Behavior, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606996
- Sponsor's protocol ID
- 1K23DA021159-01
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2008
- Last updated
- 20 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group IPT for Women Prisoners With Comorbid Substance Use and Depression
- ClinicalTrials.gov ID
- NCT00606996
- Acronym / sponsor ID
- 1K23DA021159-01
- Conditions
- Substance Abuse, Substance Dependence, Depressive Disorder
- Keywords
- Drug Abuse, Drug Dependence, Alcohol Abuse, Alcohol Dependence, Major Depressive Disorder, Dysthymic Disorder, Prisoners, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Feb 2008 (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 the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners.
Detailed description
Incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates of both substance use disorder (SUD; abuse or dependence on alcohol, illegal drugs, or prescription drugs; 70%) and depressive disorder (DD; major depressive disorder and dysthymic disorder; 20-27%). DDs tend to worsen the course of SUDs for incarcerated women by increasing their risk for suicide attempts, contributing to the persistence of substance abuse, and reducing the likelihood of a successful transition to an independent, sober life in the community. Recent evidence indicates that DDs are common in persons with SUDs, often do not remit with SUD treatment, and should be treated. Despite growing recognition that co-occurring disorders, such as DDs, among substance abusing incarcerated women present an important public health concern, integrated treatments for SUD-DD have not been well-developed for or systematically tested in this population. Group Interpersonal Psychotherapy (IPT-G) has been shown to be efficacious in treating DD in other populations and may be especially pertinent to the needs of incarcerated women with SUD-DD because interpersonal difficulties not only affect severity of depression, but are also strong predictors of drinking to cope, SUD relapse, and prison recidivism in women.
This study tests the hypotheses that as adjuncts to prison SUD treatment, IPT-G, relative to psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for:
- Reduction in the risk and severity of substance use relapse after release from prison
- Recovery from depressive disorder and reduction in depressive symptoms
- Improvement in social support and interpersonal functioning
- Reduction in the severity of legal problems during the 3 month follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT-G | Experimental | Behavioral: Group interpersonal psychotherapy (IPT-G)Group Interpersonal Psychotherapy |
| PSYCHOED | Active comparator | Behavioral: Psychoeducation on co-occurring disorders (PSYCHOED)Psychoeducation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants are recruited from prison substance use treatment programs.
- Current primary (non-substance-induced, as defined by the SCID) depressive disorder (major depressive or dysthymic disorder) after at least 4 weeks of prison SUD treatment and abstinence.
- A minimum Hamilton Depression score of 18 or higher, indicating moderate to severe depression.
- Depressive disorder at any time while not incarcerated.
- Substance use disorder one month prior to incarceration.
Key exclusion criteria (3 listed)
- Lifetime criteria for bipolar disorder
- Lifetime criteria for a psychotic disorder
- Actively suicidal
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 |
|---|---|---|
| Group interpersonal psychotherapy (IPT-G) | Behavioural | IPT-G |
| Psychoeducation on co-occurring disorders (PSYCHOED) | Behavioural | PSYCHOED |
Primary outcome
Substance-free days after release from prison, measured by the Timeline Followback method
Time frame: 3 months post-release
Severity of substance use after release from prison, measured by the Addiction Severity Index
Time frame: 3 months post-release
Verification of substance-free status using breath alcohol tests and urine drug screens
Time frame: 3 months post-release
Depression symptom severity measured by the Modified Hamilton Rating Scale for Depression
Time frame: Pre-release
Depression symptom severity measured by the Beck Depression Inventory
Time frame: Pre-release
6 secondary outcomes
Severity of legal problems after release, measured by the Legal Composite of the Addiction Severity Index
Time frame: 3 months post-release
Interpersonal problems, measured by the Inventory of Interpersonal Problems
Time frame: 3 months post-release
Peer support and social support, measured by the Criminal Justice client Evaluation of Self and Treatment
Time frame: 3 months post-release
Perceived social support measured by the Multidimensional Scale of Perceived Social Support
Time frame: 3 months post-release
Social support for recovery, measured by the Important People and Activities scale
Time frame: 3 months post-release
Social functioning, measured by the Social Adjustment Scale
Time frame: 3 months post-release
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 20 Mar 2025.
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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.
Jennifer E. Johnson, Ph.D. principal investigator
Department of Psychiatry and Human Behavior, Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group interpersonal psychotherapy (IPT-G) and Psychoeducation on co-occurring disorders (PSYCHOED) in people with Substance Abuse and Substance Dependence, run by Brown University 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 6 inclusion and 3 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 20 Mar 2025. 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?
Substance-free days after release from prison, measured by the Timeline Followback method (time frame: 3 months post-release). The study lists 5 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 20 Mar 2025.