Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03498638
Other study ID # 9-13-27
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2016
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University Hospitals Cleveland Medical Center
Contact Gunnur Karakurt, PhD
Phone 216/844-2866
Email mdp@uhhospitals.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Couples Therapy
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.
Other:
Control
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.

Locations

Country Name City State
United States University Hospitals Cleveland Medical Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Keming Gao National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and Week 8
Primary 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. Baseline and Week 8
Secondary 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. Baseline and Week 8
Secondary 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. Baseline and Week 8
Secondary Examine the correlation between one partner's psychophysiological regulation as measured by HPA activity between the other partner's HPA activity. Baseline and Week 8
Secondary Examine the correlation between one partner's psychophysiological regulation as measured by PNS activity between the other partner's PNS activity. Baseline and Week 8
See also
  Status Clinical Trial Phase
Completed NCT06284148 - Confidential IPV Screening Tool N/A
Completed NCT04095429 - Expect Respect Middle School Randomized Trial N/A
Recruiting NCT06100679 - Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation N/A
Recruiting NCT05331352 - Attachment Style and Mentalization Impact Among Women Victims of Domestic Violence N/A
Completed NCT05417919 - Solution-oriented Nursing in Violence Against Women (SONVAW) N/A
Completed NCT04625465 - Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence N/A
Not yet recruiting NCT06350383 - Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention N/A
Completed NCT03259646 - The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women N/A
Not yet recruiting NCT06124950 - A Couple-based Gender-transformative Intervention on IPV Against Infertile Women N/A
Not yet recruiting NCT06330753 - Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan N/A
Not yet recruiting NCT05310656 - Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women N/A
Recruiting NCT03623555 - Applied Social Neuroscience: the Building Resilience Among Women Project
Recruiting NCT05608421 - 1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV N/A
Recruiting NCT05609786 - Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya N/A
Recruiting NCT06001307 - Supporting Trans Affirmation, Relationships, and Sex, Phase 3 N/A
Recruiting NCT05768217 - Community Resiliency Collective Efficacy Intervention N/A
Completed NCT04950686 - Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students N/A
Completed NCT03539315 - Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh N/A
Recruiting NCT04098276 - It's WeWomen Plus Intervention for Health, Safety and Empowerment N/A
Completed NCT05163171 - Prevalence of the Victimization and the Perpetration of Intimate Partner Violence Among the Patients From Puy-de-Dôme and Paris Consulting or Being Hospitalized for Addiction Problems and Their Expectations From General Practitioners (VIA-MG)