NCT03950128

Brief Summary

The purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. The MBST focuses on improving college students' abilities to manage emotionally charged states during conflict with their romantic partners by teaching them mindfulness-based skills. The psychoeducational intervention uses the Love is Not Abuse curriculum. Treatment groups are randomly assigned and are compared using a two-armed parallel design. 88 college students currently in a dating relationship were recruited through Kent State University's subject pool. All participants completed a baseline assessment online where self-reported data was collected on demographics, dating violence (during the past month), emotion regulation, mindfulness skills, and other potential covariates. Participants were then randomized into either the MBST intervention or the psychoeducational intervention. All participants completed three 50-minute sessions over the course of three weeks with assigned homework between sessions. Daily diary data was collected, assessing knowledge and use of skills learned in the sessions. Follow-up data was collected online 11 weeks following baseline (dating violence (during the last month), emotion regulation, mindfulness skills). It was hypothesized that the MBST intervention would be more effective at reducing dating violence as compared to the psychoeducational intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

May 9, 2019

Last Update Submit

May 10, 2019

Conditions

Keywords

Dating aggressionEmotion regulationMindfulnessMindfulness-based skillsRomantic relationshipsDating relationships

Outcome Measures

Primary Outcomes (1)

  • Change in Conflict in Adolescent Dating Relationships Inventory (CADR; Wolfe et al., 2001)

    A 35-item self-report measure of physical, verbal, and sexual dating violence.

    Baseline (4th week of semester) and Follow-up (11 weeks after baseline)

Secondary Outcomes (3)

  • Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)

    Baseline (4th week of semester) and Follow-up (11 weeks after baseline)

  • The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

    Baseline (4th week of semester) and Follow-up (11 weeks after baseline)

  • 3. Intimate Partner Violence Attitudes Scale-Revised (IPVAS-R; Fincham, Cui, Braithwaite, & Pasley, 2008)

    Baseline (4th week of semester) and Follow-up (11 weeks after baseline)

Study Arms (2)

Mindfulness-Based Skills Training

EXPERIMENTAL

This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The intervention is given over the course of three 50-minute sessions with homework between sessions.

Behavioral: Mindfulness-Based Skills Training (MBST)

Psychoeducational

ACTIVE COMPARATOR

This intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions.

Behavioral: Psychoeducational

Interventions

This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The skills followed the "ABCDE" acronym. ABCDE stands for awareness, breathing, checking in with your feelings and thoughts, describing your experience, and expressing what you want to change. Students learned about the skills and had opportunities to practice them as well.

Mindfulness-Based Skills Training

This intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. The selected materials covered (a) what dating abuse is, (b) the pattern of abuse and, (c) technology and dating abuse. The curriculum is interactive and includes handouts, activities, and discussion.

Psychoeducational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In a current dating relationship (of 6 months or longer)

You may not qualify if:

  • Diagnosed with psychopathology (Major Depressive Disorder, Post-Traumatic Stress Disorder, Borderline Personality Disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Manfred van Dulmen, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean, Professor of Psychological Sciences

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 15, 2019

Study Start

February 5, 2018

Primary Completion

December 2, 2018

Study Completion

December 2, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

The PI and co-PI are the only researchers involved in the project. Thus, no plans for sharing are necessary.

Locations