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mindfulness, emotion didactics, interpersonal skills, experiential learning for Emotional Dysregulation
N/A
Waitlist Available
Led By Steve Martino, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-weeks post-randomization
Awards & highlights
Study Summary
This trial is studying a horse-assisted therapy called The Equus Effect to see if it can help improve social functioning in veterans with mental health concerns.
Eligible Conditions
- Emotional Dysregulation
- Social Skills
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16-weeks post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-weeks post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inventory of Interpersonal Problems-32 (IIP-32)
Social Adjustment Scale-Self Report (SAS-SR)
Secondary outcome measures
Difficulties in Emotion Regulation Scale (DERS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The Equus Effect (TEE)Experimental Treatment1 Intervention
TEE is a 4-session intervention. Each session is 4 hours and includes: 1) mindfulness-based activities; 2) didactics about emotion regulation and interpersonal skills; and 3) experiential learning activities with horses that provide opportunities to practice emotion regulation and interpersonal skills. At the end of each session, Veterans debrief about what they learned and identify how they might apply this knowledge to manage their mental health concerns and function better socially.
Group II: Attention Control (AC)Active Control1 Intervention
AC will exclude equine-related activities or discussions but maintain mindfulness-based activities, emotion regulation and interpersonal skills didactics, and experiential learning activities with between-session application. Instead of experiential equine activities, AC will rely on team-building activities, which aim to enhance social relations by involving participants in collaborative tasks and providing opportunities for emotion regulation and interpersonal skills practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mindfulness, emotion didactics, interpersonal skills, experiential learning
2022
N/A
~40
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,422 Total Patients Enrolled
VA Connecticut Healthcare SystemFED
81 Previous Clinical Trials
6,679 Total Patients Enrolled
Steve Martino, PhDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
4 Previous Clinical Trials
1,879 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have participated in horse therapy within the past 24 weeks.You are currently experiencing severe thoughts of hurting yourself.You have difficulties in social situations and struggle with interpersonal relationships.You have difficulty controlling your emotions, as indicated by a high score on the Difficulties in Emotion Regulation Scale (DERS).You have a mental health condition like psychosis, which is confirmed by your medical records or by a specialized interview.
Research Study Groups:
This trial has the following groups:- Group 1: The Equus Effect (TEE)
- Group 2: Attention Control (AC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for potential participants to join this medical experiment?
"According to the information provided on clinicaltrials.gov, recruitment is still in progress for this trial which was first announced on June 20th 2022 and updated as recently as July 14th 2022."
Answered by AI
How many participants has this trial enrolled?
"Confirmed. Clinicaltrials.gov contains the information that this medical trial, first posted on June 20th 2022 is actively recruiting patients and seeks 40 participants from one centre."
Answered by AI
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