Posttraumatic Stress Disorder
Conditions
Brief summary
This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of Equine-Assisted Therapy for veterans with posttraumatic stress disorder (EAT-PTSD). While several well-studied, validated treatments for PTSD exist, some individuals find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy widely used by organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a variety of mental health issues. These claims have drawn criticism because the published research contains glaring methodological flaws, making it difficult to assess how effective these therapies actually are (Anestis et al., 2014). Equine-assisted therapies present a unique treatment modality that might effectively treat PTSD, particularly for individuals who have difficulty with other treatment modalities. In EAT, a psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse using structured interventions or activities.
Detailed description
In this pilot study the investigators will develop the EAT intervention and determine whether research methods (evaluation interviews, assessment measures, videotaping procedures) are acceptable to participants. Specifically, the investigators will focus on issues such as session length, appropriateness of the content for treatment of PTSD, ordering of session content, adherence to the manual of the equine therapeutic team (based on observations made during supervision and feedback from the consultants), and will detail logistics of data collection and how best to record the sessions (camera angles, etc.).
Interventions
OTHEREAT-PTSD
Sponsors
Columbia University
Research Foundation for Mental Hygiene, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18 and 70 * Current DSM-5 diagnosis of PTSD as determined by a) full criteria met on CAPS, and b) clinical assessment * Able to give consent, fluent in English
Exclusion criteria
* History of psychiatric diagnosis of psychotic disorder, unstable bipolar disorder * Elevated depression of clinical concern and/or score of \>25 on the Hamilton Rating Scale for Depression * At elevated risk for suicide based on history and current mental state * History of substance/alcohol use disorder at severe level within the past six months, and current diagnosis of substance/alcohol use disorder at a moderate level within past two months * Fear of horses or other large animals * Orthopedic or other physical conditions and/or limitations that prevent people from walking unassisted and/or walking freely in the ring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks | 8 weeks | Change in symptoms of PTSD as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, severity rating ranging from 0-80 with higher scores indicating more severe PTSD) in a clinical interview |
Countries
United States
Participant flow
Pre-assignment details
Ninety-seven individuals were assessed for eligibility in the study, but 34 were excluded as a result of not meeting study inclusion criteria, leaving 63 participants to proceed into study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| EAT-PTSD Manualized EAT-PTSD seeks to increase affective awareness of self and others, improve communication, help regulate emotional response, improve critical thinking/problem solving, and increase self-confidence/self-efficacy while engaging with the horses. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | EAT-PTSD |
|---|---|
| Age, Continuous | 50.01 years STANDARD_DEVIATION 12.38 |
| Index Trauma Child abuse | 23 Participants |
| Index Trauma Combat-related | 27 Participants |
| Index Trauma Military sexual trauma | 23 Participants |
| Index Trauma Natural disaster | 1 Participants |
| Index Trauma Other | 16 Participants |
| Index Trauma Physical assault | 9 Participants |
| Index Trauma Sexual assault | 1 Participants |
| Index Trauma Traumatic accident | 4 Participants |
| Index Trauma Traumatic sudden loss | 7 Participants |
| Military Conflicts None | 25 Participants |
| Military Conflicts OEF/OIF | 23 Participants |
| Military Conflicts Other | 5 Participants |
| Military Conflicts Vietnam/Korea | 10 Participants |
| Race/Ethnicity, Customized Black/African-American | 26 Participants |
| Race/Ethnicity, Customized Other | 15 Participants |
| Race/Ethnicity, Customized Prefer not to respond | 6 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Service Era 1960-1969 | 6 Participants |
| Service Era 1970-1979 | 14 Participants |
| Service Era 1980-1989 | 20 Participants |
| Service Era 1990-1999 | 20 Participants |
| Service Era 2000-2009 | 31 Participants |
| Service Era 2010-2019 | 15 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Primary
Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks
Change in symptoms of PTSD as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, severity rating ranging from 0-80 with higher scores indicating more severe PTSD) in a clinical interview
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EAT-PTSD | Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks | Baseline | 38.6 score on a scale | Standard Deviation 8.1 |
| EAT-PTSD | Change From Baseline in Clinician-Administered PTSD Scale at 8 Weeks | 8 weeks | 26.9 score on a scale | Standard Deviation 12.4 |