NCT03658499

Brief Summary

Intimate partner violence (IPV) is a common occurrence in the U.S. Victims of IPV are at an elevated risk of experiencing a variety of physical and mental health consequences, which frequently co-occur and act synergistically, placing victims at a higher risk for revictimization. Experts recommend that interventions for victims of IPV focus on helping victims attain more balanced emotions and behaviors, rather than treating specific nosologies. One transdiagnostic treatment, Dialectical Behavior Therapy (DBT), focused on helping individuals gain more balanced emotions and behaviors, has shown success in treating victims of IPV. However, the DBT for IPV treatment protocol is not without it's limitations. Specifically, clients may need additional exposure to the skills and concepts taught in the treatment. Yet, additional exposure to the skills facilitated though a therapist is difficult to do given the limited budgets for services for victims of IPV and the client provider gap. In order to address the client provider gap, increase exposure to the skills, and to increase skills acquisition and generalization, video intervention adjuncts (VIAs) have been developed to serve as treatment adjuncts for the DBT for IPV skills group. The objective of the current study is to conduct a randomized control trial examining the treatment utility and participant acceptability of the two-day DBT for IPV skills group plus the VIAs versus treatment as usual (the two-day DBT for IPV skills group without the VIAs). The following hypotheses will be examined: 1) those in the experimental VIA condition will experience treatment gains above and beyond those in the control (treatment as usual) condition; 2) those in the experimental VIA condition will view the VIAs as acceptable; and 3) those in the experimental VIA condition will report a greater frequency of using the skills than those in the control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

August 31, 2018

Last Update Submit

November 3, 2020

Conditions

Keywords

intimate partner violenceDomestic ViolenceTreatment adjunctsDialectical behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Changes in the difficulties in emotion regulation scale

    The difficulties in emotion regulation scale is a 36 item self report questionnaire intended to assess multiple aspects of emotion dysregulation. Participants answer on a 1-5 likert scale, with higher scores indicating more problems with emotion regulation. Minimum score = 36 and maximum score = 180. There are six sub scales: Non-acceptance (minimum score = 6 maximum score = 36); difficulties engaging in goal directed behaviors (minimum score = 5 maximum score = 25); impulse control (minimum score = 6 maximum score = 36); lack of emotional awareness (minimum score = 6 maximum score = 36); limited access to emotion regulation strategies (minimum score = 8 maximum score= 40) and lack of emotional awareness (minimum score = 5 maximum score = 25). the sub scales are summed to create the total score.

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

Secondary Outcomes (5)

  • Changes in the Acceptance and Action questionnaire II Questionnaire - II Acceptance and Action Questionnaire - II Acceptance and Action Questionnaire - II The acceptance and action questionnaire-II

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

  • Changes in the Brief symptom inventory

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

  • Skills Use Follow-up questionnaire

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

  • Changes in the five facets of mindfulness questionnaire 15 item

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

  • Changes in the Post Traumatic Stress Disorder checklist for the DSM five civilian version

    pre-test (before beginning the intervention), 2 days post-test (after intervention completion), 1 month (after the completion of the intervention) and 3 month (after the completion of the intervention). The data will be uploaded at the end of the study

Study Arms (2)

Experimental

EXPERIMENTAL

Those assigned to the experimental condition will be provided with treatment as usual (the two day skills group) and exposure to the video intervention adjuncts. two day skills group plus treatment adjuncts

Behavioral: two day skills group plus treatment adjuncts

control

OTHER

Those in the control condition will be provided with treatment as usual (the two day skills group) without access to the video intervention adjuncts. two day skills group control group

Behavioral: two day skills group control group

Interventions

The modified dialectical behavior therapy protocol for victims of intimate partner violence dedicates additional time to address validation of self and others in order to mitigate the impact of punishing social relations, and increase the victims' access to positive reinforcement (Iverson et al., 2009). The modified protocol covers the same four major modules as the original DBT protocol in an abbreviated manner. Participants in this group will be provided with the treatment adjuncts.

Experimental

The modified dialectical behavior therapy protocol for victims of intimate partner violence dedicates additional time to address validation of self and others in order to mitigate the impact of punishing social relations, and increase the victims' access to positive reinforcement (Iverson et al., 2009). The modified protocol covers the same four major modules as the original DBT protocol in an abbreviated manner. Participants in this group will not be provided with the treatment adjuncts and will serve as the control group

control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Victim of domestic violence
  • Must be 18 years old or older
  • Speak English
  • Have a 8th grade reading level
  • Be a female
  • Have access to the internet

You may not qualify if:

  • People who are suicidal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Related Publications (15)

  • 1. Linehan, M. Cognitive-behavioral treatment of borderline personality disorder. New York, New York: Guilford press; 1993.

    BACKGROUND
  • 2. Linehan, M. M. Skills training manual for treating borderline personality disorder. New York, New York: Guilford Press; 1993.

    BACKGROUND
  • 3. Linehan, M. DBT® skills training manual. New York, New York: Guilford Publications; 2014.

    BACKGROUND
  • 4. Iverson, K.M., Shenk, C., & Fruzzetti, A. E. Dialectical behavior therapy for women victims of domestic abuse; a pilot study. Prof Psychol Res Pr. 2009;40(3); 242-248. Doi: 10.1037/a0013476

    BACKGROUND
  • 5. Ahrendt, A., Newlands, R., & Benuto, L. (2017, May). DBT for dv: New model, same positive outcomes. Poster session presented at the Nevada Psychological Association (NPA) 2017 Annual Conference, Las Vegas, NV.

    BACKGROUND
  • 6. Lee, J., & Fruzzetti, A. E. Evaluating a Brief Group Program for Women Victims of Intimate Partner Abuse. J Trauma Stress Disor Treat 2017; 6(3). doi: 10/4172/2324-8947.1000174

    BACKGROUND
  • Axelrod SR, Perepletchikova F, Holtzman K, Sinha R. Emotion regulation and substance use frequency in women with substance dependence and borderline personality disorder receiving dialectical behavior therapy. Am J Drug Alcohol Abuse. 2011 Jan;37(1):37-42. doi: 10.3109/00952990.2010.535582. Epub 2010 Nov 22.

    PMID: 21091162BACKGROUND
  • 8. Alavi, K., Modarres, G. M., Amin, Y. S. A., & Salehi, F. J. Effectiveness of group dialectical behavior therapy (based on core mindfulness, distress tolerance and emotion regulationcomponents) on depressive symptoms in university students. The Quarterly Journal of Fundamentals of Mental Health. 2011; 13(2); 124-135.

    BACKGROUND
  • Linehan MM, Schmidt H 3rd, Dimeff LA, Craft JC, Kanter J, Comtois KA. Dialectical behavior therapy for patients with borderline personality disorder and drug-dependence. Am J Addict. 1999 Fall;8(4):279-92. doi: 10.1080/105504999305686.

    PMID: 10598211BACKGROUND
  • Soeteman DI, Hakkaart-van Roijen L, Verheul R, Busschbach JJ. The economic burden of personality disorders in mental health care. J Clin Psychiatry. 2008 Feb;69(2):259-65. doi: 10.4088/jcp.v69n0212.

    PMID: 18363454BACKGROUND
  • van Asselt AD, Dirksen CD, Arntz A, Severens JL. The cost of borderline personality disorder: societal cost of illness in BPD-patients. Eur Psychiatry. 2007 Sep;22(6):354-61. doi: 10.1016/j.eurpsy.2007.04.001. Epub 2007 Jun 4.

    PMID: 17544636BACKGROUND
  • Clough BA, Casey LM. Technological adjuncts to increase adherence to therapy: a review. Clin Psychol Rev. 2011 Jul;31(5):697-710. doi: 10.1016/j.cpr.2011.03.006. Epub 2011 Mar 24.

    PMID: 21497153BACKGROUND
  • Van Ameringen M, Turna J, Khalesi Z, Pullia K, Patterson B. There is an app for that! The current state of mobile applications (apps) for DSM-5 obsessive-compulsive disorder, posttraumatic stress disorder, anxiety and mood disorders. Depress Anxiety. 2017 Jun;34(6):526-539. doi: 10.1002/da.22657. Epub 2017 Jun 1.

    PMID: 28569409BACKGROUND
  • 14. Rounsaville, B. J., Carroll, K. M., & Onken, L. S. Methodological diversity and theory in the stage model: Reply to Kazdin. Clinical Psychology Science and Practice, 2001; 8(2), 152-154. Doi: 10.1093/clipsy/8.2.152

    BACKGROUND
  • Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health. Clin Psychol Sci. 2014 Jan 1;2(1):22-34. doi: 10.1177/2167702613497932.

    PMID: 25821658BACKGROUND

Study Officials

  • Lorraine T Benuto, Ph.D.

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be divided by strata (court mandated vs. voluntary) and randomly assigned to either the experimental or control condition, after completing the two-day skills group, via a research randomizer (Urbaniak \& Plous, 2013), which randomly generates numbers that designate the assignment condition of each participant.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Director of the THRIVE Center

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 5, 2018

Study Start

July 26, 2018

Primary Completion

June 22, 2019

Study Completion

July 1, 2019

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations