Domestic ViolenceNCT01653860
Partner Violence and Anger Management
A study testing The Brøset anger management model and Ordinary group treatment in people with Domestic Violence and Spouse Abuse, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effectiveness of the Brøset anger management model in reducing violent behavior amongst clients who are violent in intimate partnerships and who voluntarily seek help. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Domestic Violence, Spouse Abuse
- What is being tested?
- The Brøset anger management model and Ordinary group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2012to 4 May 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fluent in Norwegian language
- is in a partner relationship at inclusion. Partner relationship is defined by having an intimate partner at present, or being in regular contact with a former intimate partner so that violence is possible (e.g. they have children)
- admits being violent to his partner (physical, mental and/or sexual)
Who cannot join
- psychosis
- alcohol- or drug addiction to a level that hinders group participation free from intoxication.
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs University Hospital, Division of Psychiatry, Centre for research and education in forensic psychiatry Brøset
Trondheim, 7440
About this study
Official title: Partner Violence and Anger Management: a Randomised Controlled Study of the Effectiveness of Cognitive Behavioral Therapy
The purpose of this study is to investigate the effectiveness of the Brøset anger management model in reducing violent behavior amongst clients who are violent in intimate partnerships and who voluntarily seek help.
Violence in intimate partnerships constitutes a serious problem worldwide and there is reason to believe that cognitive behavior therapy has some effect on the reduction of violent behavior. However, there are currently too few randomized controlled studies to conclude about the effectiveness of cognitive behavior therapy for this client group.
- Conditions
- Domestic Violence, Spouse Abuse
- Being tested
- The Brøset anger management model, Ordinary group treatment
- Keywords
- Behavior therapy, Group therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Brøset anger management modelBehavioural
manualised structured cognitive treatment program 15 weeks (30 hours)
Ordinary group treatmentBehavioural
group treatment 8 weeks (16 hours)
| Study group | Role | What they receive |
|---|---|---|
| The Brøset anger management model | Experimental | Group treatment Receives: Behavioral: The Brøset anger management model |
| ordinary group treatment | Active comparator | Group treatment Receives: Behavioral: Ordinary group treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
violent behaviour, reported by partner and client
measured by using the Conflict Tactics Scale Revised (CTS2), instrument for measuring violence in intimate partnerships(10), which consists of 78 questions (0-7) about different aspects of violence (frequence of physical, psychological, sexual and material violence)
Measured: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
Secondary outcomes (3)
The client's and their partner's mental health
measured by using the Hopkins Symptoms Check List (HSCL-25, with 25 questions about the presence and intensity of anxiety and depression symptoms, and symptoms of somatoform character)
Measured: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
The client's and their partner's health service use and absence due to sickness
Measured: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
Changes in emotional dysregulation
Emotional regulation will be assessed by the Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004).
Measured: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Tom Palmstierna, MD PhD prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653860
- Sponsor's protocol ID
- 2012/683
- Status last verified
- Nov 2020
- First submitted
- 25 Jul 2012
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nesset MB, Lara-Cabrera ML, Bjorngaard JH, Whittington R, Palmstierna T. Cognitive behavioural group therapy versus mindfulness-based stress reduction group therapy for intimate partner violence: a randomized controlled trial. BMC Psychiatry. 2020 Apr 19;20(1):178. doi: 10.1186/s12888-020-02582-4.
PubMed 32306935Nesset MB, Bjorngaard JH, Whittington R, Palmstierna T. Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial. Int J Nurs Stud. 2021 Jan;113:103795. doi: 10.1016/j.ijnurstu.2020.103795. Epub 2020 Oct 14.
PubMed 33120137
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partner Violence and Anger Management: a Randomised Controlled Study of the Effectiveness of Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT01653860
- Acronym / sponsor ID
- 2012/683
- Conditions
- Domestic Violence, Spouse Abuse
- Keywords
- Behavior therapy, Group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Karolinska Institutet
- Study start
- Jul 2012 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 31 Jul 2012 (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 investigate the effectiveness of the Brøset anger management model in reducing violent behavior amongst clients who are violent in intimate partnerships and who voluntarily seek help.
Violence in intimate partnerships constitutes a serious problem worldwide and there is reason to believe that cognitive behavior therapy has some effect on the reduction of violent behavior. However, there are currently too few randomized controlled studies to conclude about the effectiveness of cognitive behavior therapy for this client group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Brøset anger management model | Experimental | Behavioral: The Brøset anger management modelGroup treatment |
| ordinary group treatment | Active comparator | Behavioral: Ordinary group treatmentGroup treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fluent in Norwegian language
- is in a partner relationship at inclusion. Partner relationship is defined by having an intimate partner at present, or being in regular contact with a former intimate partner so that violence is possible (e.g. they have children)
- admits being violent to his partner (physical, mental and/or sexual)
Key exclusion criteria (2 listed)
- psychosis
- alcohol- or drug addiction to a level that hinders group participation free from intoxication.
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 |
|---|---|---|
| The Brøset anger management modelmanualised structured cognitive treatment program 15 weeks (30 hours) | Behavioural | The Brøset anger management model |
| Ordinary group treatmentgroup treatment 8 weeks (16 hours) | Behavioural | ordinary group treatment |
Primary outcome
violent behaviour, reported by partner and client
Time frame: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
measured by using the Conflict Tactics Scale Revised (CTS2), instrument for measuring violence in intimate partnerships(10), which consists of 78 questions (0-7) about different aspects of violence (frequence of physical, psychological, sexual and material violence)
3 secondary outcomes
The client's and their partner's mental health
Time frame: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
The client's and their partner's health service use and absence due to sickness
Time frame: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
Changes in emotional dysregulation
Time frame: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.
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 3 Nov 2020.
- Results publication: PubMed 32306935Nesset MB, Lara-Cabrera ML, Bjorngaard JH, Whittington R, Palmstierna T. Cognitive behavioural group therapy versus mindfulness-based stress reduction group therapy for intimate partner violence: a randomized controlled trial. BMC Psychiatry. 2020 Apr 19;20(1):178. doi: 10.1186/s12888-020-02582-4.
- Results publication: PubMed 33120137Nesset MB, Bjorngaard JH, Whittington R, Palmstierna T. Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial. Int J Nurs Stud. 2021 Jan;113:103795. doi: 10.1016/j.ijnurstu.2020.103795. Epub 2020 Oct 14.
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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.
Tom Palmstierna, MD PhD prof principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Brøset anger management model and Ordinary group treatment in people with Domestic Violence and Spouse Abuse, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 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 3 Nov 2020. 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 Norway. 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?
violent behaviour, reported by partner and client (time frame: 3 months between assessments, 1 year duration, i.e. baseline and 4 follow-up assessments. In accordance with the original Norwegian protocol.). 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 NCT01653860, which also lists 2 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 3 Nov 2020.