Domestic ViolenceNCT00847873
Treatment of Intimate Partner Violence and Substance Abuse in a Substance Abuse Treatment Facility
A study testing substance abuse/domestic violence treatment and Cognitive behavioral therapy addressing substance abuse in people with Domestic Violence and Substance Abuse, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Intimate partner violence is a significant societal problem. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Domestic Violence, Substance Abuse
- What is being tested?
- substance abuse/domestic violence treatment and Cognitive behavioral therapy addressing substance abuse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perpetration of intimate partner violence in the past year
- Substance abuse or dependence (current)
- Currently in a relationship
Who cannot join
- Not sufficient fluency in Dutch to complete treatment and measures
- (Ab)use of crack cocaine and/or heroin
- Psychosis
- Psychopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Intimate Partner Violence and Substance Abuse in a Substance Abuse: a Randomized Controlled Trial
Intimate partner violence is a significant societal problem. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.
Read the detailed description
Intimate partner violence is a significant societal problem. However, treatment of IPV perpetrators is far from effective, which may be partly due to the fact that the role of substance abuse is not taken into account. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.
- Conditions
- Domestic Violence, Substance Abuse
- Being tested
- substance abuse/domestic violence treatment, Cognitive behavioral therapy addressing substance abuse
- Keywords
- intimate partner violence, domestic violence, alcohol abuse, alcohol dependence, drug abuse, drug dependence, addiction
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
substance abuse/domestic violence treatmentBehavioural
Also called Treatment for intimate partner violence, Treatment for addiction
This intervention is comprised of 16 sessions of cognitive behavioral therapy. 8 sessions are addressing partner violence and 8 sessions are addressing substance abuse
Cognitive behavioral therapy addressing substance abuseBehavioural
Also called Treatment for addiction
This intervention is comprised of 16 sessions of cognitive behavioral therapy addressing substance abuse.
| Study group | Role | What they receive |
|---|---|---|
| Combined SU/IPV treatment | Experimental | A combined treatment containing cognitive behavioral therapy addressing partner violence and cognitive behavioral therapy addressing substance abuse Receives: Behavioral: substance abuse/domestic violence treatment |
| control condition | Active comparator | Cognitive behavioral therapy addressing substance abuse Receives: Behavioral: Cognitive behavioral therapy addressing substance abuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use: Timeline followback interview (TLFB)
Measured: pretest, posttest, 6 & 12 months follow-up
IPV: Conflict Tactics Scale 2 (CTS2)
Measured: pretest, halfway treatment, posttest, 6 and 12 months follow-up
Secondary outcomes (4)
Brief Symptom Inventory (BSI)
Measured: pretest, posttest
Substance use: Quick drinking and drug use screen
Measured: Pretest, halfway treatment, posttest, 6 and 12 months follow-up
Maudsley Marital Questionnaire (MMQ)
Measured: Pretest, posttest, 6 and 12 months follow-up
Treatment Satisfaction Questionnaire
Measured: posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul M. Emmelkamp, PhD., Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847873
- Sponsor's protocol ID
- 2008-KP-466
- Status last verified
- Nov 2013
- First submitted
- 18 Feb 2009
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intimate Partner Violence and Substance Abuse in a Substance Abuse: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00847873
- Acronym / sponsor ID
- 2008-KP-466
- Conditions
- Domestic Violence, Substance Abuse
- Keywords
- intimate partner violence, domestic violence, alcohol abuse, alcohol dependence, drug abuse, drug dependence, addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Feb 2009 (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.
Intimate partner violence is a significant societal problem. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.
Detailed description
Intimate partner violence is a significant societal problem. However, treatment of IPV perpetrators is far from effective, which may be partly due to the fact that the role of substance abuse is not taken into account. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, patients in substance abuse treatment for the use of alcohol, cannabis or cocaine who also admit to perpetrating intimate partner violence will be randomly assigned to either cognitive behavioral therapy addressing substance abuse combined with treatment for offenders of intimate partner violence or substance abuse treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined SU/IPV treatment | Experimental | Behavioral: substance abuse/domestic violence treatmentA combined treatment containing cognitive behavioral therapy addressing partner violence and cognitive behavioral therapy addressing substance abuse |
| control condition | Active comparator | Behavioral: Cognitive behavioral therapy addressing substance abuseCognitive behavioral therapy addressing substance abuse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Perpetration of intimate partner violence in the past year
- Substance abuse or dependence (current)
- Currently in a relationship
Key exclusion criteria (4 listed)
- Not sufficient fluency in Dutch to complete treatment and measures
- (Ab)use of crack cocaine and/or heroin
- Psychosis
- Psychopathy
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 |
|---|---|---|
| substance abuse/domestic violence treatmentAlso: Treatment for intimate partner violence, Treatment for addictionThis intervention is comprised of 16 sessions of cognitive behavioral therapy. 8 sessions are addressing partner violence and 8 sessions are addressing substance abuse | Behavioural | Combined SU/IPV treatment |
| Cognitive behavioral therapy addressing substance abuseAlso: Treatment for addictionThis intervention is comprised of 16 sessions of cognitive behavioral therapy addressing substance abuse. | Behavioural | control condition |
Primary outcome
Substance use: Timeline followback interview (TLFB)
Time frame: pretest, posttest, 6 & 12 months follow-up
IPV: Conflict Tactics Scale 2 (CTS2)
Time frame: pretest, halfway treatment, posttest, 6 and 12 months follow-up
4 secondary outcomes
Brief Symptom Inventory (BSI)
Time frame: pretest, posttest
Substance use: Quick drinking and drug use screen
Time frame: Pretest, halfway treatment, posttest, 6 and 12 months follow-up
Maudsley Marital Questionnaire (MMQ)
Time frame: Pretest, posttest, 6 and 12 months follow-up
Treatment Satisfaction Questionnaire
Time frame: posttest
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 5 Nov 2013.
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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.
Paul M. Emmelkamp, PhD. principal investigator
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing substance abuse/domestic violence treatment and Cognitive behavioral therapy addressing substance abuse in people with Domestic Violence and Substance Abuse, run by VU University of Amsterdam at 1 site in Netherlands.
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 3 inclusion and 4 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 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 Netherlands. 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 use: Timeline followback interview (TLFB) (time frame: pretest, posttest, 6 & 12 months follow-up). 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 5 Nov 2013.