Violence, DomesticNCT03498638
Feasibility Study of Couple Therapy Treatment for Situational Couple Violence
A study testing Couples Therapy in people with Violence, Domestic, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand whether the couple therapy that is used in practice is effective in preventing situational couple violence. More specifically, investigators will focus on couples with mild to moderate forms of situational couple violence to investigate how couples therapy can be effective in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Violence, Domestic
- What is being tested?
- Couples Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2016to 24 May 2017
- 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
- This study is open to married, dating, and cohabiting couples.
- Couples will have to be involved in an intimate relationship with their current partner for at least one year.
- Both partners have to be older than 18 years of age at the time they sign consent.
- Couples must have mild to moderate forms of situational couple violence.
- Both partners must want couples therapy and both partners must desire to maintain the relationship.
- Both individuals from the couple must participate concurrently, although they will sometimes be separated when asked questions of a sensitive nature.
- Only heterosexual couples will be included in the study.
- Both partners can be on psychotropic medication, if they are on medication and stable for past 12 month prior to enrollment, and no psychiatric hospitalization for past 2 years.
Who cannot join
- Couples will be excluded from the study if there are indicators of severe intimate partner violence and/or characterological violence as this study targets couples with mild to moderate levels of violence. In order to distinguish between these two different types of violence, we will use specific items in the Conflict Tactic Scale (CTS) completed by both parties (Johnson, \& Leone, 2005). Severe and/or characterological violence in this study is defined as follows:
- If participants answer yes to both of the following items: "I punched or hit my partner with something that could hurt", "I kicked my partner".
- If participants answer yes to any of the following items: "I choked my partner," "I slammed my partner against a wall," "I beat up my partner" "I burned or scalded my partner on purpose," and "I used a knife or gun on my partner".
- One of the partners reports that a violent behavior was repeated at least six times in a year by their partner or themselves.
- Participants will also be excluded from the study if they answer yes to the following questions: "Do you have any firearms at home?", "In your previous relationships, did your partners ever tell you that you were physically abusive?"
- Participants will be excluded from the study if they are not stable on psychiatric medication for more than 12 months.
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- Couples will be excluded from the study if there is a discrepancy between partners' reports of violence (received or perpetrated) in the CTS, defined as the difference between the partners' reports of the frequency of a particular act by the same partner. If the difference of the average score of the partners, or for any of the acts in the scale in the CTS is greater than 2, the couple will be excluded from the study. For example, if the female partner reports that the male partner pushed her three times but the male partner reports that he never pushed his partner, the couple will be excluded from the study since the couple will receive a difference score of three for the act of pushing.
- Participants will be excluded from the study if undiagnosed, untreated serious mental illness is suspected during pre-screening. In order to screen participants with severe mental health problems, Symptom Checklist (SCL90) will be used. We will use the cut off 0.885 with the area under the receiver operating characteristic (ROC) curve with lower and upper bounds of the 95% confidence interval.
- Participants will be excluded from the study if there are indicators of substance misuse. We will use the 16 item Simple Screening Instrument for Substance Abuse (SSISA) to screen participants' substance use. We'll score only 14 items out of the 16 items, which were selected by the Treatment Improvement Protocols (TIP) 11 consensus panelists from existing alcohol and drug abuse screening tools. A score of 4 or greater has become the established cutoff point.
- Participants will be excluded if they reported any history of violent legal offences in the past 2 years.
- Participants will be excluded if participants are currently suicidal and/or psychotic and/or patients who is moderately ill (e.g. equivalent of Clinical Global Impression (CGI) score 3 or greater) at the pre-screening.
- Participants who are not literate or cannot speak English will be excluded. The questionnaires require a 6th grade reading level.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to understand whether the couple therapy that is used in practice is effective in preventing situational couple violence. More specifically, investigators will focus on couples with mild to moderate forms of situational couple violence to investigate how couples therapy can be effective in preventing the escalation and recurrence of situational couple violence. For this purpose, the response of partners to therapy will be investigated by integrating self-report questionnaires and psycho-physiological markers of emotion.
- Conditions
- Violence, Domestic
- Being tested
- Couples Therapy, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples TherapyBehavioural
Couples in the intervention group will receive couples therapy for 8 weekly sessions. Each therapy session will last approximately an hour. All therapies will be conducted by the PI, Dr. Gunnur Karakurt. Dr. Karakurt is a Licenced Marriage and Family Therapist and AAMFT (American Association of Marriage and Family Therapy) approved clinical supervisor. All therapies will be conducted as a couple. Training on stress management and safety planning will be performed as individuals. There will not be any group sessions. The goal of couple therapy is to help and improve couples' capacity to regulate emotions, solve problems, and communicate through therapy with the couple together.
ControlOther
Couples in the control group will be taught safety planning, given information on local resources to help victims of violence, and will be instructed in stress and anger management strategies. Following this 8 week period, they will receive 8 weeks of couple therapy unless they choose not to.
| Study group | Role | What they receive |
|---|---|---|
| Couples Therapy | Experimental | Couples Therapy Receives: Behavioral: Couples Therapy |
| Control | Placebo comparator | Couples Therapy after an 8 week waiting period Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between change in Intimate Partner Violence (IPV) and change each partner's psychophysiological regulation in terms of Hypothalamic Pituitary Adrenal (HPA) activity
This aim will investigate whether dysregulation of HPA activity in each partner is correlated with the existence and intensity of IPV for the couple. HPA activity will be measured using salivary cortisol.
Measured: Baseline and Week 8
Examine the associations between change IPV and change each partner's psychophysiological regulation in terms of Parasympathetic Nervous System (PNS) activity.
This aim will investigate whether dysregulation of PNS activity in each partner is correlated with the existence and intensity of IPV for the couple. PNS activity will be measured using vagal tone and vagal regulation by using an eMotion Heart Rate Variability (HRV) sensor.
Measured: Baseline and Week 8
Secondary outcomes (4)
Examine the longitudinal effects of conjoint therapy on IPV and each partner's psychophysiological regulation in terms of HPA
In couples where IPV decreases, this aim will investigate whether that decrease in IPV is correlated with a change in regulation of HPA activity for each partner.
Measured: Baseline and Week 8
Examine the longitudinal effects of conjoint therapy on IPV and each partner's psychophysiological regulation in terms of PNS activity
In couples where IPV decreases, this aim will investigate whether that decrease in IPV is correlated with a change in regulation of PNS activity for each partner.
Measured: Baseline and Week 8
Examine the correlation between one partner's psychophysiological regulation as measured by HPA activity between the other partner's HPA activity.
Measured: Baseline and Week 8
Examine the correlation between one partner's psychophysiological regulation as measured by PNS activity between the other partner's PNS activity.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start19 Jan 2016
- Primary completion24 May 2017
- Study completion24 May 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Keming Gao, University Hospitals Cleveland Medical Center
- Investigators
- Gunnur Karakurt, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498638
- Sponsor's protocol ID
- 9-13-27
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2018
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Couple Therapy Treatment for Situational Couple Violence
- ClinicalTrials.gov ID
- NCT03498638
- Acronym / sponsor ID
- 9-13-27
- Conditions
- Violence, Domestic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 17 Apr 2018 (actual)
- 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 understand whether the couple therapy that is used in practice is effective in preventing situational couple violence. More specifically, investigators will focus on couples with mild to moderate forms of situational couple violence to investigate how couples therapy can be effective in preventing the escalation and recurrence of situational couple violence. For this purpose, the response of partners to therapy will be investigated by integrating self-report questionnaires and psycho-physiological markers of emotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples Therapy | Experimental | Behavioral: Couples TherapyCouples Therapy |
| Control | Placebo comparator | Other: ControlCouples Therapy after an 8 week waiting period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- This study is open to married, dating, and cohabiting couples.
- Couples will have to be involved in an intimate relationship with their current partner for at least one year.
- Both partners have to be older than 18 years of age at the time they sign consent.
- Couples must have mild to moderate forms of situational couple violence.
- Both partners must want couples therapy and both partners must desire to maintain the relationship.
Key exclusion criteria (12 listed)
- Couples will be excluded from the study if there are indicators of severe intimate partner violence and/or characterological violence as this study targets couples with mild to moderate levels of violence. In order to distinguish between these two different types of violence, we will use specific items in the Conflict Tactic Scale (CTS) completed by both parties (Johnson, \& Leone, 2005). Severe and/or characterological violence in this study is defined as follows:
- Participants will also be excluded from the study if they answer yes to the following questions: "Do you have any firearms at home?", "In your previous relationships, did your partners ever tell you that you were physically abusive?"
- Participants will be excluded from the study if they are not stable on psychiatric medication for more than 12 months.
- Couples will be excluded from the study if there is a discrepancy between partners' reports of violence (received or perpetrated) in the CTS, defined as the difference between the partners' reports of the frequency of a particular act by the same partner. If the difference of the average score of the partners, or for any of the acts in the scale in the CTS is greater than 2, the couple will be excluded from the study. For example, if the female partner reports that the male partner pushed her three times but the male partner reports that he never pushed his partner, the couple will be excluded from the study since the couple will receive a difference score of three for the act of pushing.
- Participants will be excluded from the study if undiagnosed, untreated serious mental illness is suspected during pre-screening. In order to screen participants with severe mental health problems, Symptom Checklist (SCL90) will be used. We will use the cut off 0.885 with the area under the receiver operating characteristic (ROC) curve with lower and upper bounds of the 95% confidence interval.
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 |
|---|---|---|
| Couples TherapyCouples in the intervention group will receive couples therapy for 8 weekly sessions. Each therapy session will last approximately an hour. All therapies will be conducted by the PI, Dr. Gunnur Karakurt. Dr. Karakurt is a Licenced Marriage and Family Therapist and AAMFT (American Association of Marriage and Family Therapy) approved clinical supervisor. All therapies will be conducted as a couple. Training on stress management and safety planning will be performed as individuals. There will not be any group sessions. The goal of couple therapy is to help and improve couples' capacity to regulate emotions, solve problems, and communicate through therapy with the couple together. | Behavioural | Couples Therapy |
| ControlCouples in the control group will be taught safety planning, given information on local resources to help victims of violence, and will be instructed in stress and anger management strategies. Following this 8 week period, they will receive 8 weeks of couple therapy unless they choose not to. | Other | Control |
Primary outcome
Association between change in Intimate Partner Violence (IPV) and change each partner's psychophysiological regulation in terms of Hypothalamic Pituitary Adrenal (HPA) activity
Time frame: Baseline and Week 8
This aim will investigate whether dysregulation of HPA activity in each partner is correlated with the existence and intensity of IPV for the couple. HPA activity will be measured using salivary cortisol.
Examine the associations between change IPV and change each partner's psychophysiological regulation in terms of Parasympathetic Nervous System (PNS) activity.
Time frame: Baseline and Week 8
This aim will investigate whether dysregulation of PNS activity in each partner is correlated with the existence and intensity of IPV for the couple. PNS activity will be measured using vagal tone and vagal regulation by using an eMotion Heart Rate Variability (HRV) sensor.
4 secondary outcomes
Examine the longitudinal effects of conjoint therapy on IPV and each partner's psychophysiological regulation in terms of HPA
Time frame: Baseline and Week 8
Examine the longitudinal effects of conjoint therapy on IPV and each partner's psychophysiological regulation in terms of PNS activity
Time frame: Baseline and Week 8
Examine the correlation between one partner's psychophysiological regulation as measured by HPA activity between the other partner's HPA activity.
Time frame: Baseline and Week 8
Examine the correlation between one partner's psychophysiological regulation as measured by PNS activity between the other partner's PNS activity.
Time frame: Baseline and Week 8
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- 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.
Gunnur Karakurt, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples Therapy in people with Violence, Domestic, run by University Hospitals Cleveland Medical Center 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Feb 2026. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Association between change in Intimate Partner Violence (IPV) and change each partner's psychophysiological regulation in terms of Hypothalamic Pituitary Adrenal (HPA) activity (time frame: Baseline and Week 8). 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 10 Feb 2026.