AggressionNCT01337973
Preventing Violence Among Veterans in Substance Use Disorder Treatment
A study testing MI-CBT, MI-CBT+CC and E-TAU in people with Aggression and Substance-Related Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggression, Substance-Related Disorders
- What is being tested?
- MI-CBT, MI-CBT+CC and E-TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2012to 1 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with severe and recent violence (i.e., injuring another person in the past year) will be eligible for the RCT.
- Eligible patients also will meet DSM-IV criteria for either alcohol or illicit drug (e.g., cocaine, marijuana, opiates, etc.) abuse/dependence.
- The study will include those with comorbid mood and/or anxiety problems (e.g., depression, PTSD and other anxiety disorders), whether or not on medication at the point of recruitment, with the exception of those who have schizophrenia and/or are mentally incompetent (e.g., unable to provide informed consent).
- A brief mental status screen will with an established cutoff will be required for competency.
Who cannot join
- Participants who are suicidal (ideation, intent and plan) at the point of recruitment will not be enrolled in the study. Rather, research staff will inform clinical staff at the study site if a potential participant is currently suicidal.
- Participants who report transient suicidal ideation but no intent or plan will be eligible to participate.
- As noted, individuals with schizophrenia and/or who are mentally incompetent to consent for participation will be excluded. Finally, participants who live outside the study catchment area (i.e., a 45 mile radius of the VA Ann Arbor Healthcare System) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients
The purpose of this study is to examine the impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of
- an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence prevention treatment intervention delivered during the 8-week early substance use disorder treatment phase; and
- MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC).
The study will provide important new information regarding the role and relative impact of both early treatment and continuing care interventions designed to impact substance use and violence, and whether combining such interventions yields additional benefits.
Read the detailed description
Objective: Rates of violence in Substance Use Disorder (SUD) treatment samples often exceed 50%, with studies showing rates of past-year violence >70% when considering violence occurring with either intimate partners or others. Violence has numerous costs to Veterans and their families, in terms of physical (e.g., injuries) and psychosocial problems (mental health, legal problems, marital problems, poorer functioning for their children, etc.). To date, only one treatment approach (Behavioral Couples Therapy - BCT) has been established that reduces both substance use and violence, and BCT focuses exclusively on the couples' relationship. Given that a small proportion of Veterans in SUD treatment have a partner willing or able to attend treatment, and that a substantial amount of violence occurs with non-partners, there is a clear need for interventions that do not require partner participation and focus on violence and relapse prevention more generally. Based on prior findings, new intervention approaches targeting the use of violence prevention skills and means of sustaining substance use remission are needed.
The primary objectives of this study are to examine the impact on both substance use and violence outcomes of:
- an acute treatment phase integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT); and
- MI-CBT plus a violence and substance use prevention Continuing Care intervention (MI-CBT+CC) intervention.
Research Plan: Participants will be randomized to one of three conditions: MI-CBT, MI-CBT+CC or an enhanced treatment as usual (E-TAU) control condition with follow-up interviews targeting violence and substance use outcomes at 3, 6 and 12-months. The MI-CBT intervention involves six individual sessions delivered during the acute SUD treatment phase, combines Motivational Interviewing (MI) and CBT approaches targeting violence and substance use, and has been developed, piloted and refined by the investigators. The MI-CBT+CC intervention includes acute phase MI-CBT plus weekly telephone sessions for an additional 3-month period, and is designed to address both post-treatment violence and substance use through facilitating SUD remission and use of violence prevention skills. The MI-CBT+CC intervention is adapted from a continuing care intervention shown to help consolidate and maintain gains made in treatment.
Methods: Veterans with substance use disorders will be recruited from the Substance Abuse Clinic (SAC) at the VA Ann Arbor Healthcare system. Approximately 855 Veterans enrolling in SAC will be consented and screened, and those screening positive for severe and recent violence (~30%) and meeting other project inclusion/exclusion criteria will be eligible for participation in the randomized controlled trial (n = 210). The clinical interventions will be delivered by master's level clinicians, who will be monitored and supervised by licensed psychologists. Primary dependent measures (violence, substance use) will be measured at baseline and follow-up interviews, and the impact of the interventions on services use during the follow-up period also will be examined.
- Conditions
- Aggression, Substance-Related Disorders
- Being tested
- MI-CBT, MI-CBT+CC, E-TAU
- Keywords
- violence, aggression, Substance-Related Disorders, Alcohol-Related Disorders, Drug-Related Disorders
- Medical subject headings
- Aggression, Substance-Related Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-CBTBehavioural
Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches
MI-CBT+CCBehavioural
Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention
E-TAUBehavioural
Enhanced Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MI-CBT | Experimental | MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) Receives: Behavioral: MI-CBT |
| Arm 2: MI-CBT+CC | Experimental | MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) Receives: Behavioral: MI-CBT+CC |
| Arm 3: E-TAU | Active comparator | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) Receives: Behavioral: E-TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conflict Tactics Scale-Structured Interview (CTS-SI)
The CTS-SI is a semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents). Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the month rate of various types of interpersonal aggression from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants. There were primary aggression outcomes (overall physical aggression, injuring another person), and secondary aggression outcomes (partner physical aggression and injury, nonpartner physical aggression and injury).
Measured: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
Secondary outcomes (1)
Percent Change in the Percentage of Days of Substance Use for Each Substance
Data was collected via a Time-line Follow Back interview. Semi-structured interview assessing alcohol and drug use. Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the monthly rate of various types of substance use (heavy drinking, cocaine, marijuana, and illicit) from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. (% days use for each substance) Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants.
Measured: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study start20 Jun 2012
- Primary completion1 Dec 2016
- Study completion1 Dec 2017
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 (6)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen T. Chermack, PhD MA BA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337973
- Sponsor's protocol ID
- IIR 09-333
- Other IDs
- HX000294
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2010
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis AK, Bonar EE, Ilgen MA, Walton MA, Perron BE, Chermack ST. Factors associated with having a medical marijuana card among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2016 Dec;63:132-6. doi: 10.1016/j.addbeh.2016.07.006. Epub 2016 Jul 8.
PubMed 27475408Bennett DC, Morris DH, Sexton MB, Bonar EE, Chermack ST. Associations between posttraumatic stress and legal charges among substance using veterans. Law Hum Behav. 2018 Apr;42(2):135-144. doi: 10.1037/lhb0000268. Epub 2017 Oct 26.
PubMed 29072473Anderson RE, Bonar EE, Walton MA, Goldstick JE, Rauch SAM, Epstein-Ngo QM, Chermack ST. A Latent Profile Analysis of Aggression and Victimization Across Relationship Types Among Veterans Who Use Substances. J Stud Alcohol Drugs. 2017 Jul;78(4):597-607. doi: 10.15288/jsad.2017.78.597.
PubMed 28728642Davis AK, Bonar EE, Goldstick JE, Walton MA, Winters J, Chermack ST. Binge-drinking and non-partner aggression are associated with gambling among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2017 Nov;74:27-32. doi: 10.1016/j.addbeh.2017.05.022. Epub 2017 May 20.
PubMed 28570911Buchholz KR, Bohnert KM, Sripada RK, Rauch SA, Epstein-Ngo QM, Chermack ST. Associations between PTSD and intimate partner and non-partner aggression among substance using veterans in specialty mental health. Addict Behav. 2017 Jan;64:194-199. doi: 10.1016/j.addbeh.2016.08.039. Epub 2016 Aug 31.
PubMed 27636157Chermack ST, Bonar EE, Goldstick JE, Winters J, Blow FC, Friday S, Ilgen MA, Rauch SAM, Perron BE, Ngo QM, Walton MA. A randomized controlled trial for aggression and substance use involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care. J Subst Abuse Treat. 2019 Mar;98:78-88. doi: 10.1016/j.jsat.2019.01.001. Epub 2019 Jan 4.
PubMed 30665608
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interventions to Reduce Violence and Substance Abuse Among VA Patients
- ClinicalTrials.gov ID
- NCT01337973
- Acronym / sponsor ID
- IIR 09-333
- Conditions
- Aggression, Substance-Related Disorders
- Keywords
- violence, aggression, Substance-Related Disorders, Alcohol-Related Disorders, Drug-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Posted 6 Sep 2019
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 impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of
- an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence prevention treatment intervention delivered during the 8-week early substance use disorder treatment phase; and
- MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC).
The study will provide important new information regarding the role and relative impact of both early treatment and continuing care interventions designed to impact substance use and violence, and whether combining such interventions yields additional benefits.
Detailed description
Objective: Rates of violence in Substance Use Disorder (SUD) treatment samples often exceed 50%, with studies showing rates of past-year violence >70% when considering violence occurring with either intimate partners or others. Violence has numerous costs to Veterans and their families, in terms of physical (e.g., injuries) and psychosocial problems (mental health, legal problems, marital problems, poorer functioning for their children, etc.). To date, only one treatment approach (Behavioral Couples Therapy - BCT) has been established that reduces both substance use and violence, and BCT focuses exclusively on the couples' relationship. Given that a small proportion of Veterans in SUD treatment have a partner willing or able to attend treatment, and that a substantial amount of violence occurs with non-partners, there is a clear need for interventions that do not require partner participation and focus on violence and relapse prevention more generally. Based on prior findings, new intervention approaches targeting the use of violence prevention skills and means of sustaining substance use remission are needed.
The primary objectives of this study are to examine the impact on both substance use and violence outcomes of:
- an acute treatment phase integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT); and
- MI-CBT plus a violence and substance use prevention Continuing Care intervention (MI-CBT+CC) intervention.
Research Plan: Participants will be randomized to one of three conditions: MI-CBT, MI-CBT+CC or an enhanced treatment as usual (E-TAU) control condition with follow-up interviews targeting violence and substance use outcomes at 3, 6 and 12-months. The MI-CBT intervention involves six individual sessions delivered during the acute SUD treatment phase, combines Motivational Interviewing (MI) and CBT approaches targeting violence and substance use, and has been developed, piloted and refined by the investigators. The MI-CBT+CC intervention includes acute phase MI-CBT plus weekly telephone sessions for an additional 3-month period, and is designed to address both post-treatment violence and substance use through facilitating SUD remission and use of violence prevention skills. The MI-CBT+CC intervention is adapted from a continuing care intervention shown to help consolidate and maintain gains made in treatment.
Methods: Veterans with substance use disorders will be recruited from the Substance Abuse Clinic (SAC) at the VA Ann Arbor Healthcare system. Approximately 855 Veterans enrolling in SAC will be consented and screened, and those screening positive for severe and recent violence (~30%) and meeting other project inclusion/exclusion criteria will be eligible for participation in the randomized controlled trial (n = 210). The clinical interventions will be delivered by master's level clinicians, who will be monitored and supervised by licensed psychologists. Primary dependent measures (violence, substance use) will be measured at baseline and follow-up interviews, and the impact of the interventions on services use during the follow-up period also will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MI-CBT | Experimental | Behavioral: MI-CBTMI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) |
| Arm 2: MI-CBT+CC | Experimental | Behavioral: MI-CBT+CCMI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) |
| Arm 3: E-TAU | Active comparator | Behavioral: E-TAUE-TAU (enhanced treatment as usual - includes brief session and provision of resources) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with severe and recent violence (i.e., injuring another person in the past year) will be eligible for the RCT.
- Eligible patients also will meet DSM-IV criteria for either alcohol or illicit drug (e.g., cocaine, marijuana, opiates, etc.) abuse/dependence.
- The study will include those with comorbid mood and/or anxiety problems (e.g., depression, PTSD and other anxiety disorders), whether or not on medication at the point of recruitment, with the exception of those who have schizophrenia and/or are mentally incompetent (e.g., unable to provide informed consent).
- A brief mental status screen will with an established cutoff will be required for competency.
Key exclusion criteria (3 listed)
- Participants who are suicidal (ideation, intent and plan) at the point of recruitment will not be enrolled in the study. Rather, research staff will inform clinical staff at the study site if a potential participant is currently suicidal.
- Participants who report transient suicidal ideation but no intent or plan will be eligible to participate.
- As noted, individuals with schizophrenia and/or who are mentally incompetent to consent for participation will be excluded. Finally, participants who live outside the study catchment area (i.e., a 45 mile radius of the VA Ann Arbor Healthcare System) will be excluded.
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 |
|---|---|---|
| MI-CBTSix individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches | Behavioural | Arm 1: MI-CBT |
| MI-CBT+CCAcute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention | Behavioural | Arm 2: MI-CBT+CC |
| E-TAUEnhanced Treatment as Usual | Behavioural | Arm 3: E-TAU |
Primary outcome
Conflict Tactics Scale-Structured Interview (CTS-SI)
Time frame: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
The CTS-SI is a semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents). Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the month rate of various types of interpersonal aggression from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants. There were primary aggression outcomes (overall physical aggression, injuring another person), and secondary aggression outcomes (partner physical aggression and injury, nonpartner physical aggression and injury).
1 secondary outcome
Percent Change in the Percentage of Days of Substance Use for Each Substance
Time frame: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27475408Davis AK, Bonar EE, Ilgen MA, Walton MA, Perron BE, Chermack ST. Factors associated with having a medical marijuana card among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2016 Dec;63:132-6. doi: 10.1016/j.addbeh.2016.07.006. Epub 2016 Jul 8.
- Background: PubMed 29072473Bennett DC, Morris DH, Sexton MB, Bonar EE, Chermack ST. Associations between posttraumatic stress and legal charges among substance using veterans. Law Hum Behav. 2018 Apr;42(2):135-144. doi: 10.1037/lhb0000268. Epub 2017 Oct 26.
- Background: PubMed 28728642Anderson RE, Bonar EE, Walton MA, Goldstick JE, Rauch SAM, Epstein-Ngo QM, Chermack ST. A Latent Profile Analysis of Aggression and Victimization Across Relationship Types Among Veterans Who Use Substances. J Stud Alcohol Drugs. 2017 Jul;78(4):597-607. doi: 10.15288/jsad.2017.78.597.
- Background: PubMed 28570911Davis AK, Bonar EE, Goldstick JE, Walton MA, Winters J, Chermack ST. Binge-drinking and non-partner aggression are associated with gambling among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2017 Nov;74:27-32. doi: 10.1016/j.addbeh.2017.05.022. Epub 2017 May 20.
- Background: PubMed 27636157Buchholz KR, Bohnert KM, Sripada RK, Rauch SA, Epstein-Ngo QM, Chermack ST. Associations between PTSD and intimate partner and non-partner aggression among substance using veterans in specialty mental health. Addict Behav. 2017 Jan;64:194-199. doi: 10.1016/j.addbeh.2016.08.039. Epub 2016 Aug 31.
- Results publication: PubMed 30665608Chermack ST, Bonar EE, Goldstick JE, Winters J, Blow FC, Friday S, Ilgen MA, Rauch SAM, Perron BE, Ngo QM, Walton MA. A randomized controlled trial for aggression and substance use involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care. J Subst Abuse Treat. 2019 Mar;98:78-88. doi: 10.1016/j.jsat.2019.01.001. Epub 2019 Jan 4.
- 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.
Stephen T. Chermack, PhD MA BA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-CBT, MI-CBT+CC and E-TAU in people with Aggression and Substance-Related Disorders, run by VA Office of Research and Development 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 4 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 6 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 6 Sep 2019). 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?
Conflict Tactics Scale-Structured Interview (CTS-SI) (time frame: % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data). 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 NCT01337973, which also lists 6 linked publications.
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 6 Sep 2019.