Substance Use DisordersNCT00734903
Women Veterans' Substance Abuse Treatment
A study testing A Woman's Path to Recovery and 12-Step Facilitation in people with Substance Use Disorders, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- A Woman's Path to Recovery and 12-Step Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female Veteran
- 18-65 years of age
- Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)
- Plan to stay in the Boston area for the next 6 months
- Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment
- Able to complete the Statement of Informed Consent
Show all 12Show fewer
- Willing to participate in all assessments and breathalyzer/urine testing
- Willing to provide a release of information such that study staff can contact her other providers as needed regarding any concerns during her participation
- Able to obtain medical clearance
- Willing to allow us to contact family and/or friends if participant loses contact with us
- Literate
- Not pregnant or planning to become pregnant
Who cannot join
- Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)
- Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)
- Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated
- Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)
- Client is mandated to treatment
- Psychopharmacologic treatment that is planned to change or likely to change substantively over the 3-month active treatment phase (with "substantive" defined as any addition of a new medication or major shift in dosage)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 02459
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: A Randomized Controlled Trial on Women's Substance Abuse Treatment
The purpose of this study is to examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.
Read the detailed description
Substance use disorder (SUD) is problem among women military Veterans, especially younger ones. The goal of this study was to examine the efficacy a gender-focused model of SUD treatment (A Woman's Path to Recovery, WPR) compared to an evidence-based active comparator that is not gender-specific (12-Step Facilitation, 12SF), in a sample of for women Veterans. The investigators randomized 66 women Veterans, ages 18-65, who were diagnosed with current SUD and used substances in the last 90 days. The treatment phase was 12 weekly individual therapy sessions and all participants could also obtain treatment-as-usual (any other treatments they chose to attend). Assessments were conducted at baseline, end of treatment and 3-month follow up. Sample size was based on power analysis (an effect of .80 at a .05 level of significance). The primary outcome variable was substance use, with various secondary outcomes also studied (e.g., psychosocial functioning, psychiatric symptoms, coping skills, 12-step attendance). Urinalysis / breathalyzer (biological measures) were also included to validate substance use self-report. The investigators hypothesized that participants in the experimental condition (WPR) would have more positive outcomes on both primary and secondary variables compared to those in the comparison condition (12SF). The investigators also hypothesized that WPR patients would increase coping skills more and 12SF would increase 12-step attendance more, relative to the other condition.
- Conditions
- Substance Use Disorders
- Being tested
- A Woman's Path to Recovery, 12-Step Facilitation
- Keywords
- Women, Substance Use Disorders, Treatment Efficacy, Women's Health, Outcome Assessment (Health Care)
- 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.
A Woman's Path to RecoveryBehavioural
Also called A Woman's Addiction Workbook
WPR is a gender-specific therapy model for women with substance use disorder. It uses A Woman's Addiction Workbook to provide education and coping skills. In this trial it was conducted in 12 weekly individual sessions.
12-Step FacilitationBehavioural
12SF is an evidence-based therapy designed to facilitate early recovery from substance addiction. It is an individual model consisting of 12 sessions that use the principles of 12-step groups such as Alcoholics Anonymous, and strongly emphasizes participation in those. In this trial the model was conducted weekly.
| Study group | Role | What they receive |
|---|---|---|
| A Woman's Path to Recovery (WPR) | Experimental | A gender-focused approach to addiction recovery Receives: Behavioral: A Woman's Path to Recovery |
| 12-Step Facilitation (TSF) | Active comparator | An evidence-based, non-gender-focused approach to addiction recovery Receives: Behavioral: 12-Step Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity Index Alcohol Composite
Alcohol use and associated problems as measured by blinded-interviewer rated composite score. Six questions comprise the alcohol composite, of which 4 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Breathalyzer was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Drug Composite
Drug use and associated problems as measured by blinded-interviewer rated composite score. Urinalysis/breathalyzer is also obtained to verify self-report.Drug use and associated problems as measured by blinded-interviewer rated composite score. Eleven questions comprise the drug composite, of which 9 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Urinanalysis was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
Measured: Baseline, end of treatment (3 months), and 3-month post-treatment followup
Brief Addiction Monitor
Assesses number of days in the past 30 days that person used substances including alcohol and drugs
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Secondary outcomes (8)
Addiction Severity Index Medical Composite Score
Medical problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Employment Composite
Employment problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Psychiatric Composite
Psychiatric problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Family/Social Composite
Family/social problems associated with substance use as measured by blinded-interviewer rated composite score. Several questions are answered from 0-30 (number of days in past month) and the remaining 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome).
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Global Severity Index of the Brief Symptom Inventory
Self-report measure of severity of general psychiatric symptoms ranging from 0 (not at all) to 4 (extremely). The total scale score Global severity index (GSI) is the mean of all 53 items on the measures. The mean ranges from 0 to 4, with higher indicating worse pathology.
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
BASIS-24 Psychosocial Functioning
24 items that address how patients feel before and after receiving care. The survey measures the degree of difficulty experienced by the patient during a one-week period on a five-point scale ranging from 0 (no difficulty) to extreme difficulty (4) with the overall score ranging from 0-96.
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Coping Skills Measure
Self-report measure of confidence in ability to cope comprising 18 items, each scaled from 0 (not at all) to 5 (extremely). The mean across all 18 items ranges from 0 to 5 with higher scores indicating less pathology (i.e., stronger ability to cope).
Measured: Baseline, end of treatment, 3-month post-treatment follow-up
Alcoholics Anonymous (AA) Intention Measure
Self-reported attitudes toward attending 12-step meetings; a scale of 17 items, each rated 1 (extremely unlikely) to 7 (extremely likely). The mean across all items thus ranges from 1 to 7 with with more positive scores indicating a more positive attitude toward 12-step meetings.
Measured: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startOct 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa M. Najavits, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734903
- Sponsor's protocol ID
- NEUA-001-08S
- Status last verified
- Feb 2018
- First submitted
- 12 Aug 2008
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Najavits LM, Enggasser J, Brief D, Federman E. A randomized controlled trial of a gender-focused addiction model versus 12-step facilitation for women veterans. Am J Addict. 2018 Apr;27(3):210-216. doi: 10.1111/ajad.12709.
PubMed 29596724
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Women's Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT00734903
- Acronym / sponsor ID
- NEUA-001-08S
- Conditions
- Substance Use Disorders
- Keywords
- Women, Substance Use Disorders, Treatment Efficacy, Women's Health, Outcome Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 5 Nov 2018
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 examine the efficacy of a gender-focused addiction treatment model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model (12-Step Facilitation) in a sample of women Veterans with substance use disorder.
Detailed description
Substance use disorder (SUD) is problem among women military Veterans, especially younger ones. The goal of this study was to examine the efficacy a gender-focused model of SUD treatment (A Woman's Path to Recovery, WPR) compared to an evidence-based active comparator that is not gender-specific (12-Step Facilitation, 12SF), in a sample of for women Veterans. The investigators randomized 66 women Veterans, ages 18-65, who were diagnosed with current SUD and used substances in the last 90 days. The treatment phase was 12 weekly individual therapy sessions and all participants could also obtain treatment-as-usual (any other treatments they chose to attend). Assessments were conducted at baseline, end of treatment and 3-month follow up. Sample size was based on power analysis (an effect of .80 at a .05 level of significance). The primary outcome variable was substance use, with various secondary outcomes also studied (e.g., psychosocial functioning, psychiatric symptoms, coping skills, 12-step attendance). Urinalysis / breathalyzer (biological measures) were also included to validate substance use self-report. The investigators hypothesized that participants in the experimental condition (WPR) would have more positive outcomes on both primary and secondary variables compared to those in the comparison condition (12SF). The investigators also hypothesized that WPR patients would increase coping skills more and 12SF would increase 12-step attendance more, relative to the other condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Woman's Path to Recovery (WPR) | Experimental | Behavioral: A Woman's Path to RecoveryA gender-focused approach to addiction recovery |
| 12-Step Facilitation (TSF) | Active comparator | Behavioral: 12-Step FacilitationAn evidence-based, non-gender-focused approach to addiction recovery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female Veteran
- 18-65 years of age
- Meet DSM-IV criteria for current SUD with "current" defined as meeting SUD criteria per the DSM-IV and having used a substance within the 90 days prior to intake (to be able to accurately evaluate changes in their substance use from baseline)
- Plan to stay in the Boston area for the next 6 months
- Have a mailing address and live close enough to come to the hospital once weekly for treatment and/or assessment
Key exclusion criteria (6 listed)
- Any acute medical condition that would interfere with the participant's ability to participate in treatment, or would be of such severity as to affect the individual's psychological functioning (e.g., cancer)
- Current bipolar I disorder, schizophrenia or other psychotic disorders or mental retardation or organic mental disorder (determined by screening interview)
- Any clinical sign that the client is not sufficiently stable to participate in the treatment, such as client's treatment provider indicating that participation in the treatment would be contraindicated
- Dangerousness that would present a threat to other staff or other clients (e.g., history of recent assault)
- Client is mandated to treatment
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 |
|---|---|---|
| A Woman's Path to RecoveryAlso: A Woman's Addiction WorkbookWPR is a gender-specific therapy model for women with substance use disorder. It uses A Woman's Addiction Workbook to provide education and coping skills. In this trial it was conducted in 12 weekly individual sessions. | Behavioural | A Woman's Path to Recovery (WPR) |
| 12-Step Facilitation12SF is an evidence-based therapy designed to facilitate early recovery from substance addiction. It is an individual model consisting of 12 sessions that use the principles of 12-step groups such as Alcoholics Anonymous, and strongly emphasizes participation in those. In this trial the model was conducted weekly. | Behavioural | 12-Step Facilitation (TSF) |
Primary outcome
Addiction Severity Index Alcohol Composite
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Alcohol use and associated problems as measured by blinded-interviewer rated composite score. Six questions comprise the alcohol composite, of which 4 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Breathalyzer was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
Addiction Severity Index Drug Composite
Time frame: Baseline, end of treatment (3 months), and 3-month post-treatment followup
Drug use and associated problems as measured by blinded-interviewer rated composite score. Urinalysis/breathalyzer is also obtained to verify self-report.Drug use and associated problems as measured by blinded-interviewer rated composite score. Eleven questions comprise the drug composite, of which 9 are answered from 0-30 (number of days in past month) and 2 are subjective Likert ratings 0 (not at all) to 4 (extremely), with higher scores on all items indicating worse pathology. Composite scores are computed and range from 0 (worst outcome) to 1 (best outcome). Urinanalysis was also obtained to verify self-report and was coded as positive (worst pathology, means patient was intoxicated) or negative (not pathological; patient was not intoxicated).
Brief Addiction Monitor
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Assesses number of days in the past 30 days that person used substances including alcohol and drugs
8 secondary outcomes
Addiction Severity Index Medical Composite Score
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Employment Composite
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Psychiatric Composite
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Addiction Severity Index Family/Social Composite
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Global Severity Index of the Brief Symptom Inventory
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
BASIS-24 Psychosocial Functioning
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Coping Skills Measure
Time frame: Baseline, end of treatment, 3-month post-treatment follow-up
Alcoholics Anonymous (AA) Intention Measure
Time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29596724Najavits LM, Enggasser J, Brief D, Federman E. A randomized controlled trial of a gender-focused addiction model versus 12-step facilitation for women veterans. Am J Addict. 2018 Apr;27(3):210-216. doi: 10.1111/ajad.12709.
- Individual participant dataSharing planned: No
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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.
Lisa M. Najavits, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Woman's Path to Recovery and 12-Step Facilitation in people with Substance Use Disorders, run by VA Office of Research and Development at 2 sites 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 12 inclusion and 6 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 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Addiction Severity Index Alcohol Composite (time frame: Baseline, end of treatment (month 3), 3-month post-treatment follow-up). The study lists 3 primary outcomes in all. 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 NCT00734903, 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 5 Nov 2018.