Domestic ViolenceNCT03658499
Evaluating the Clinical Utility and Client Acceptability of Video Intervention
A study testing two day skills group plus treatment adjuncts in people with Domestic Violence, run by Rory Newlands at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- two day skills group plus treatment adjuncts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 1 Jul 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People who are suicidal
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Dialectical Behavioral Therapy as a treatment for IPV victims. Integrating the literature on efficacious cognitive behavioral treatments for disorders such as anxiety, depression, and other emotion regulation difficulties, Linehan developed the framework for DBT.1 In addition to these traditional CBT change-oriented techniques, which may leave clients feeling blamed for their problems or situation, Linehan incorporated radical acceptance. Radical acceptance emphasizes that self-compassion and acceptance (i.e. accepting how things really are rather than how they 'should' be) are necessary for making meaningful changes. When operating from a DBT framework the therapist's goal is to balance and synthesize acceptance and change-oriented strategies. Individuals who have experienced IPV often struggle to accept their situation (e.g. "But I love him," or "he said he will never do it again… although he said that before") and often receive blame from others for their situation (e.g. "Why wouldn't you just leave?"). Treating victims of IPV using a DBT framework allows victims to learn skills to change their situation in a non-judgmental and validating environment.
In addition to providing victims with a validating environment, DBT aims to foster emotion regulation, enhance interpersonal effectiveness, improve self-validation, and increase distress tolerance. Mindfulness (i.e. present-moment awareness, acceptance, and participation without judgment) is core to these skills and to DBT. 2 Overview of the DBT for IPV Treatment Protocol. The DBT for IPV protocol is delivered in a group setting led by two co-therapists. Handouts adapted from the DBT Skills Training: Handouts and Worksheets are provided to clients in session, and homework is provided to help with the retention of the content.3 The DBT for IPV protocol can be broken down into five overarching themes or concepts: mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness, and validation. These concepts form the foundation of the original 12-week closed model, the open group model and the intensive two-day group.4-6 The open group focuses on one module per session, where as the closed group and the two-day group start by introducing the intervention's two foundational topics: mindfulness and behavioral chains. Each module covers several concepts that link back to these two topics.
These five modules were designed to address the psychological sequelae frequently experienced by victims of IPV, as well as to address the underlying mechanisms driving psychological distress among victims of IPV. In addition to reducing revictimization by addressing mental health problems, the DBT for IPV treatment paradigm provides clients with skills (i.e. interpersonal effectiveness and validation) to improve their relationships and reduce the occurrence of violence in their relationships.
Treatment adjuncts. While DBT has demonstrated success in treating a multiple psychological issues, such as suicidal ideation, substance abuse, anger, emotional dysregulation and distress tolerance, it is a costly and time-intensive intervention.7-11 However, research has shown that treatment adjuncts, such as apps and websites, enhance treatment outcomes for a various psychological disorders.12 Technology disseminated interventions have been shown to effectively reduce symptoms of depression, PTSD and anxiety.13 In their review of mobile apps for the treatment of mental disorder, Ameringen and colleagues (2017) noted that employing technology-based interventions might reduce the need for in-person appointments with clinicians, particularly for clients who encounter geographical, time, or financial barriers.13 Further they concluded that apps improve treatment engagement with clinicians and provide opportunities for clinicians to reinforce skills and concepts they taught their clients in session.13 In addition to using treatment adjuncts to enhance treatment outcomes above and beyond treatment as usual, therapists can use treatment adjuncts such as video intervention adjuncts (VIAs), which deliver intervention content via multimedia, as a means of reducing therapist burden.
Research Design and Rationale The objective of this study is to conduct a randomized control trial (RCT) examining the implementation of VIAs, developed for the purpose of enhancing skills generalization, acquisition, and (ultimately) treatment outcomes for DBT for IPV skills group members. Stratified randomization (controlling for those who are court mandated to treatment) will be used assigned participants to the experimental condition (the two-day skills group + the VIAs) or a control condition (the two-day skills group only). The primary outcomes are as follows: 1) investigate whether exposure to the VIA enhances treatment gains above and beyond treatment as usual; 2) assess participant acceptability of the VIAs; and 3) determine if participants in the experimental VIA condition will report a higher frequency of using the skills over the follow-up period than those in the control condition. Following the guidelines for developing and researching behavioral therapies, a Stage One Pilot Trial will be conducted, focusing on feasibility, participant acceptability, and treatment outcome.14 Participants. Following the Onken, Carroll, Shoham, Cuthbert, and Riddle (2014) guidelines for conducting clinical research, a Stage One Pilot Trial will be conducted.15 Stage 1-A is modification or refinement of an existing intervention, and Stage 1-B is feasibility and pilot testing. In this study, the existing intervention is the DBT for IPV skills workshop and the modification is the addition of the VIAs. Because Stage One trials recommend 15-30 subjects per group, the study will require a sample N of 81 (assuming an attrition rate of 35% as reported in Lee and Fruzzetti's 2017 study) to meet the goal N of 60.
Screening and recruitment. Participants will include those who seek services through the THRIVE Center. Community recruitment efforts will include advertising and contacting connections at local community agencies and resource centers for victims of IPV (e.g. temporary protection order offices, Reno Police Department, District Attorney offices, etc.). Individuals interested in receiving treatment will complete intake measures prior to beginning treatment to establish a baseline, at a one-month follow-up, and three-month follow-up.
Intervention. The DBT for IPV skills protocol consists of five major interconnected topics: mindfulness, emotion regulation, distress tolerance, validation, and interpersonal effectiveness. The two-day skills group will be conducted on weekends to increase the likelihood that participants will be able to attend. The skills group will be scheduled from 9am-4pm with a one-hour lunch break (lunch will be provided).
Experimental condition. Participants assigned to the experimental condition will receive a text or email message approximately every two days with a link to a VIA hosted on the online research platform Qualtrics. Each VIA reviews one of the core skills that was taught as part of the two-day skills group. Participants will be asked questions regarding whether the VIA helped them better understand the concept/skill, whether they enjoyed the VIA, and three questions about the content (to serve as a manipulation check). A correct repose to two of the three manipulation check questions will qualify the individual as having completed that VIA.
Control Condition. Participants assigned to the control condition will receive the two-day skills group without the VIAs.
- Conditions
- Domestic Violence
- Being tested
- two day skills group plus treatment adjuncts, two day skills group control group
- Keywords
- intimate partner violence, Domestic Violence, Treatment adjuncts, Dialectical behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two day skills group plus treatment adjunctsBehavioural
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.
two day skills group control groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: two day skills group control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The seven item questionnaire assesses psychological flexibility. Participants answer on a 1-7 likert scale, with higher scores indicating Higher scores indicating greater levels of psychological inflexibility. Minimum score = 7 and maximum score = 105.
Measured: 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
The brief symptom inventory is a 53 item self-report assessment designed to measure psychological distress as well as various psychological disorders/issues The BSI has nine subscales designed to assess individual symptom groups: somatization (SOM), obsessive-compulsive (OC), interpersonal sensitivity (IS), depression (DEP), anxiety (ANX), hostility (HOS), phobic anxiety (PHB, ), paranoid ideation (PAR), and psychoticism (PSY). The BSI also includes three scales that capture global psychological distress. Participants answer on a 0-4 likert scale, with higher scores indicating greater levels of psychopathology psychological issues. The minimum raw score is 0 and the maximum raw score is 212. Raw scores are converted to t-scores. The t-scores range from 30 to 80, with higher t-scores indicating greater disfunction. The global score equals the sum of all 53 items
Measured: 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
This questionnaire asks participants if/how many times they have used the skills taught in the skills group since participating in the group. Responses range from 0 to 100, with higher numbers equating to higher usage of the skills.
Measured: 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
This 15 item self-report question is designed to measure mindfulness. Participants answer on a 1-5 likert scale, with higher scores indicating greater levels of mindfulness. Minimum score = 15 and maximum score = 75. There are five sub scales: Observing (minimum score = 3 maximum score = 15); describing (minimum score = 3 maximum score = 15); acting with awareness (minimum score = 3 maximum score = 15); Non-judging (minimum score = 3 maximum score = 15); and non-reactivity (minimum score = 3 maximum score = 15). the sub scales are summed to create the total score.
Measured: 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
This 20 item self-report scale it is designed to capture symptoms of PTSD. Participants answer on a 0-4 likert scale, with higher scores indicating higher levels of PTSD symptomology. Minimum score = 0 and maximum score = 80.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start26 Jul 2018
- Primary completion22 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rory Newlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rory Newlands, University of Nevada, Reno
- Investigators
- Lorraine T Benuto, Ph.D., Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658499
- Sponsor's protocol ID
- 1245130-1
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Linehan, M. Cognitive-behavioral treatment of borderline personality disorder. New York, New York: Guilford press; 1993.
2. Linehan, M. M. Skills training manual for treating borderline personality disorder. New York, New York: Guilford Press; 1993.
3. Linehan, M. DBT® skills training manual. New York, New York: Guilford Publications; 2014.
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
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.
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
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.
PubMed 210911628. 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.
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.
PubMed 10598211Soeteman 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.
PubMed 18363454van 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.
PubMed 17544636Clough 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.
PubMed 21497153Van 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.
PubMed 2856940914. 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
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.
PubMed 25821658
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Utility and Client Acceptability of Video Intervention
- ClinicalTrials.gov ID
- NCT03658499
- Acronym / sponsor ID
- 1245130-1
- Conditions
- Domestic Violence
- Keywords
- intimate partner violence, Domestic Violence, Treatment adjuncts, Dialectical behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rory NewlandsUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 22 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 5 Sep 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.
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.
Detailed description
Dialectical Behavioral Therapy as a treatment for IPV victims. Integrating the literature on efficacious cognitive behavioral treatments for disorders such as anxiety, depression, and other emotion regulation difficulties, Linehan developed the framework for DBT.1 In addition to these traditional CBT change-oriented techniques, which may leave clients feeling blamed for their problems or situation, Linehan incorporated radical acceptance. Radical acceptance emphasizes that self-compassion and acceptance (i.e. accepting how things really are rather than how they 'should' be) are necessary for making meaningful changes. When operating from a DBT framework the therapist's goal is to balance and synthesize acceptance and change-oriented strategies. Individuals who have experienced IPV often struggle to accept their situation (e.g. "But I love him," or "he said he will never do it again… although he said that before") and often receive blame from others for their situation (e.g. "Why wouldn't you just leave?"). Treating victims of IPV using a DBT framework allows victims to learn skills to change their situation in a non-judgmental and validating environment.
In addition to providing victims with a validating environment, DBT aims to foster emotion regulation, enhance interpersonal effectiveness, improve self-validation, and increase distress tolerance. Mindfulness (i.e. present-moment awareness, acceptance, and participation without judgment) is core to these skills and to DBT. 2 Overview of the DBT for IPV Treatment Protocol. The DBT for IPV protocol is delivered in a group setting led by two co-therapists. Handouts adapted from the DBT Skills Training: Handouts and Worksheets are provided to clients in session, and homework is provided to help with the retention of the content.3 The DBT for IPV protocol can be broken down into five overarching themes or concepts: mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness, and validation. These concepts form the foundation of the original 12-week closed model, the open group model and the intensive two-day group.4-6 The open group focuses on one module per session, where as the closed group and the two-day group start by introducing the intervention's two foundational topics: mindfulness and behavioral chains. Each module covers several concepts that link back to these two topics.
These five modules were designed to address the psychological sequelae frequently experienced by victims of IPV, as well as to address the underlying mechanisms driving psychological distress among victims of IPV. In addition to reducing revictimization by addressing mental health problems, the DBT for IPV treatment paradigm provides clients with skills (i.e. interpersonal effectiveness and validation) to improve their relationships and reduce the occurrence of violence in their relationships.
Treatment adjuncts. While DBT has demonstrated success in treating a multiple psychological issues, such as suicidal ideation, substance abuse, anger, emotional dysregulation and distress tolerance, it is a costly and time-intensive intervention.7-11 However, research has shown that treatment adjuncts, such as apps and websites, enhance treatment outcomes for a various psychological disorders.12 Technology disseminated interventions have been shown to effectively reduce symptoms of depression, PTSD and anxiety.13 In their review of mobile apps for the treatment of mental disorder, Ameringen and colleagues (2017) noted that employing technology-based interventions might reduce the need for in-person appointments with clinicians, particularly for clients who encounter geographical, time, or financial barriers.13 Further they concluded that apps improve treatment engagement with clinicians and provide opportunities for clinicians to reinforce skills and concepts they taught their clients in session.13 In addition to using treatment adjuncts to enhance treatment outcomes above and beyond treatment as usual, therapists can use treatment adjuncts such as video intervention adjuncts (VIAs), which deliver intervention content via multimedia, as a means of reducing therapist burden.
Research Design and Rationale The objective of this study is to conduct a randomized control trial (RCT) examining the implementation of VIAs, developed for the purpose of enhancing skills generalization, acquisition, and (ultimately) treatment outcomes for DBT for IPV skills group members. Stratified randomization (controlling for those who are court mandated to treatment) will be used assigned participants to the experimental condition (the two-day skills group + the VIAs) or a control condition (the two-day skills group only). The primary outcomes are as follows: 1) investigate whether exposure to the VIA enhances treatment gains above and beyond treatment as usual; 2) assess participant acceptability of the VIAs; and 3) determine if participants in the experimental VIA condition will report a higher frequency of using the skills over the follow-up period than those in the control condition. Following the guidelines for developing and researching behavioral therapies, a Stage One Pilot Trial will be conducted, focusing on feasibility, participant acceptability, and treatment outcome.14 Participants. Following the Onken, Carroll, Shoham, Cuthbert, and Riddle (2014) guidelines for conducting clinical research, a Stage One Pilot Trial will be conducted.15 Stage 1-A is modification or refinement of an existing intervention, and Stage 1-B is feasibility and pilot testing. In this study, the existing intervention is the DBT for IPV skills workshop and the modification is the addition of the VIAs. Because Stage One trials recommend 15-30 subjects per group, the study will require a sample N of 81 (assuming an attrition rate of 35% as reported in Lee and Fruzzetti's 2017 study) to meet the goal N of 60.
Screening and recruitment. Participants will include those who seek services through the THRIVE Center. Community recruitment efforts will include advertising and contacting connections at local community agencies and resource centers for victims of IPV (e.g. temporary protection order offices, Reno Police Department, District Attorney offices, etc.). Individuals interested in receiving treatment will complete intake measures prior to beginning treatment to establish a baseline, at a one-month follow-up, and three-month follow-up.
Intervention. The DBT for IPV skills protocol consists of five major interconnected topics: mindfulness, emotion regulation, distress tolerance, validation, and interpersonal effectiveness. The two-day skills group will be conducted on weekends to increase the likelihood that participants will be able to attend. The skills group will be scheduled from 9am-4pm with a one-hour lunch break (lunch will be provided).
Experimental condition. Participants assigned to the experimental condition will receive a text or email message approximately every two days with a link to a VIA hosted on the online research platform Qualtrics. Each VIA reviews one of the core skills that was taught as part of the two-day skills group. Participants will be asked questions regarding whether the VIA helped them better understand the concept/skill, whether they enjoyed the VIA, and three questions about the content (to serve as a manipulation check). A correct repose to two of the three manipulation check questions will qualify the individual as having completed that VIA.
Control Condition. Participants assigned to the control condition will receive the two-day skills group without the VIAs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: two day skills group plus treatment adjunctsThose 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 |
| control | Other | Behavioral: two day skills group control groupThose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Victim of domestic violence
- Must be 18 years old or older
- Speak English
- Have a 8th grade reading level
- Be a female
Key exclusion criteria (1 listed)
- People who are suicidal
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 |
|---|---|---|
| two day skills group plus treatment adjunctsThe 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. | Behavioural | Experimental |
| two day skills group control groupThe 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 | Behavioural | control |
Primary outcome
Changes in the difficulties in emotion regulation scale
Time frame: 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
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.
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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 2020.
- Background1. Linehan, M. Cognitive-behavioral treatment of borderline personality disorder. New York, New York: Guilford press; 1993.
- Background2. Linehan, M. M. Skills training manual for treating borderline personality disorder. New York, New York: Guilford Press; 1993.
- Background3. Linehan, M. DBT® skills training manual. New York, New York: Guilford Publications; 2014.
- Background4. 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
- Background5. 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.
- Background6. 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: PubMed 21091162Axelrod 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.
- Background8. 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: PubMed 10598211Linehan 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.
- Background: PubMed 18363454Soeteman 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.
- Background: PubMed 17544636van 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.
- Background: PubMed 21497153Clough 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.
- 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.
Lorraine T Benuto, Ph.D. principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two day skills group plus treatment adjuncts in people with Domestic Violence, run by Rory Newlands 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 6 inclusion and 1 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 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 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. 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?
Changes in the difficulties in emotion regulation scale (time frame: 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). 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 NCT03658499, which also lists 15 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 5 Nov 2020.