Trial Outcomes & Findings for Feasibility and Acceptability Off The Equus Effect (NCT NCT04159506)

Last Updated: 2024-09-26

Results Overview

SAS-SR details social functioning in a range of role areas (e.g., work, social and leisure, family); the overall SAS-SR score is 1 (no impairment), to 5 (highest impairment).

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

Baseline, 4-weeks post-randomization, 16-weeks post-randomization

Results posted on

2024-09-26

Participant Flow

Between June 2022 and February 2023 veterans were recruited through direct-to-participant advertising involving posting VA Connecticut IRB approved flyers in clinical spaces and research recruitment boards at outpatient mental health clinics, intensive outpatient/rehabilitation programs, and a community care center. Initial phone or in-person contact with potential participants offered study information and invitation to complete a preliminary screener to determine potential study eligibility.

After the preliminary screener, veterans completed a secondary screening that included completing the Mini-International Neuropsychiatric Interview (MINI) to rule out a psychotic disorder, as well as the Social Adjustment Scale-Self Report (SAS-SR); Inventory of Interpersonal Problems-32 (IIP-32); and Difficulties in Emotion Regulation Scale (DERS) to further determine inclusion and exclusion criteria and ensure minimal threshold levels of social dysfunction and emotion dysregulation.

Participant milestones

Participant milestones
Measure	The Equus Effect (TEE) 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Overall Study STARTED	16	15
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	The Equus Effect (TEE) 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Overall Study Lost to Follow-up	2	5

Baseline Characteristics

Feasibility and Acceptability Off The Equus Effect

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Equus Effect (TEE) n=16 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses.	Attention Control (AC) n=15 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through team-building activities.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	49.81 years STANDARD_DEVIATION 16.73 • n=5 Participants	49.47 years STANDARD_DEVIATION 13.65 • n=7 Participants	49.65 years STANDARD_DEVIATION 15.06 • n=5 Participants
Sex/Gender, Customized Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex/Gender, Customized Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Nonbinary	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4-weeks post-randomization, 16-weeks post-randomization

Population: Full sample of 31 participants was used in baseline analyses. 26 participants had complete data for 4-week post-randomization. 24 participants had complete data for 16-week post-randomization.

SAS-SR details social functioning in a range of role areas (e.g., work, social and leisure, family); the overall SAS-SR score is 1 (no impairment), to 5 (highest impairment).

Outcome measures

Outcome measures
Measure	The Equus Effect (TEE) n=16 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) n=15 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Social Adjustment Scale-Self Report (SAS-SR) Baseline	2.92 score on a scale Interval 2.3 to 3.46	2.92 score on a scale Interval 2.12 to 4.46
Social Adjustment Scale-Self Report (SAS-SR) 4-week post-randomization	2.30 score on a scale Interval 1.46 to 3.4	2.32 score on a scale Interval 1.26 to 3.5
Social Adjustment Scale-Self Report (SAS-SR) 16-week post-randomization	2.56 score on a scale Interval 1.34 to 2.83	2.57 score on a scale Interval 1.58 to 3.8

PRIMARY outcome

Timeframe: Baseline, 4-weeks post-randomization, 16-weeks post-randomization

IIP-32 taps people's interpersonal difficulties across role areas; the IIP-32 total score is 0 (no difficulties), to 4 (extreme difficulties).

Outcome measures

Outcome measures
Measure	The Equus Effect (TEE) n=16 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) n=15 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Inventory of Interpersonal Problems-32 (IIP-32) Baseline	2.06 score on a scale Interval 1.43 to 3.37	1.62 score on a scale Interval 0.5 to 2.81
Inventory of Interpersonal Problems-32 (IIP-32) 4-week post-randomization	1.59 score on a scale Interval 1.21 to 2.37	1.76 score on a scale Interval 0.34 to 2.59
Inventory of Interpersonal Problems-32 (IIP-32) 16-week post-randomization	1.48 score on a scale Interval 0.34 to 2.4	1.18 score on a scale Interval 0.43 to 2.93

SECONDARY outcome

Timeframe: Baseline, 4-weeks post-randomization, 16-weeks post-randomization

DERS scores range from 36-180, with higher scores indicating more emotion dysregulation.

Outcome measures

Outcome measures
Measure	The Equus Effect (TEE) n=16 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) n=15 Participants 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Difficulties in Emotion Regulation Scale (DERS) Baseline	119.00 score on a scale Interval 95.0 to 170.0	113.00 score on a scale Interval 95.0 to 149.0
Difficulties in Emotion Regulation Scale (DERS) 4-week post-randomization	117.00 score on a scale Interval 48.0 to 154.0	107 score on a scale Interval 61.0 to 150.0
Difficulties in Emotion Regulation Scale (DERS) 16-week post-randomization	114.00 score on a scale Interval 68.0 to 130.0	107.50 score on a scale Interval 43.0 to 151.0

Adverse Events

The Equus Effect (TEE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control (AC)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	The Equus Effect (TEE) n=16 participants at risk 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) n=15 participants at risk 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Psychiatric disorders Hospitalization	0.00% 0/16 • Adverse event information was collected from June 2022 through July 2023, the period of time when all screening, baseline and 4-week and 16-week post-randomization assessments occurred. clinicaltrials.gov definitions were used.	6.7% 1/15 • Number of events 1 • Adverse event information was collected from June 2022 through July 2023, the period of time when all screening, baseline and 4-week and 16-week post-randomization assessments occurred. clinicaltrials.gov definitions were used.

Other adverse events

Other adverse events
Measure	The Equus Effect (TEE) n=16 participants at risk 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.	Attention Control (AC) n=15 participants at risk 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. mindfulness, emotion didactics, interpersonal skills, experiential learning: mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
Psychiatric disorders suicide ideation	0.00% 0/16 • Adverse event information was collected from June 2022 through July 2023, the period of time when all screening, baseline and 4-week and 16-week post-randomization assessments occurred. clinicaltrials.gov definitions were used.	6.7% 1/15 • Number of events 1 • Adverse event information was collected from June 2022 through July 2023, the period of time when all screening, baseline and 4-week and 16-week post-randomization assessments occurred. clinicaltrials.gov definitions were used.

Additional Information

Steve Martino, Ph.D.

VA Connecticut Healthcare System

Phone: 203-932-5718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place