Clinical trial NCT06723834: Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD
Official title: Psychiatric Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
PTSD
Animal-Human Bonding
Combat Stress Disorders
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-12-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.

Detailed description: Posttraumatic stress disorder (PTSD) is common among military Service Members and Veterans (hereafter, "Veterans"). Symptoms of flashbacks, nightmares, and panic attacks can have devastating impacts on Veterans and their families. Suicide and suicidality are also closely linked to PTSD, and the rate of death by suicide among Veterans is nearly double that of the civilian population. PTSD is also difficult to treat. Many Veterans either do not seek treatment at all, or if they start treatment, do not finish. Even if treatment is completed, many Veterans still suffer symptoms and even retain their PTSD diagnosis. There is a critical need to find ways to reduce dropout rates, thus improving the effectiveness of existing, gold-standard treatments and promoting positive outcomes for Veterans and their families.

In their search for effective treatments, some Veterans are turning to add-on interventions for PTSD, such as partnership with a Service Dog. Under the Americans with Disabilities Act (ADA), service dogs are defined as dogs trained to perform specific tasks to mitigate a disability. Service dogs for PTSD are trained in tasks including detecting and alerting to signs of distress to interrupt anxiety and panic attacks and retrieving medication. In addition to trained tasks, service dogs live with the Veterans to provide emotional value as a source of comfort and companionship. Under the ADA guidance, Veterans with PTSD have the legal right to be accompanied by their service dog in public places such as grocery stores, workplaces, and schools. In this study, service dogs will be sourced from Assistance Dog International (ADI) accredited providers.

Service Dogs for Veterans are not only increasingly in demand, but a growing body of evidence demonstrates that Service Dogs can significantly improve the lives of Veterans with PTSD. Unfortunately, there is currently no research exploring whether adding a Service Dog will impact the effectiveness of evidence-based PTSD treatments, such as Prolonged Exposure Therapy (PE). Prolonged Exposure Therapy is a gold-standard, frontline treatment for PTSD that is highly effective, but has high rates of dropout.

PE teaches individuals with PTSD to gradually approach trauma-related memories, feelings, and situations that they have been avoiding since their trauma. By confronting these challenges, participants can decrease their PTSD symptoms. PE treatment typically last 12 weeks for 75-90 minutes, once per week.

Initial findings suggest that Service Dogs may help Veterans stay in Prolonged Exposure Therapy resulting in better treatment outcomes. However, some mental health professionals worry that Service Dogs may in fact interfere with treatment goals. This novel study is designed to help understand the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy.

Eligibility criteria: Inclusion Criteria:

* Applied for and approved to receive a psychiatric service dog from a service dog organization participating in the study
* Diagnosis of PTSD on the CAPS-5-R

Exclusion Criteria:

* Current service dog
* Current participation in Prolonged Exposure Therapy

Primary outcomes:
measure: PTSD Symptom Severity (Self-report)
timeFrame: 3 months after start of PE
Secondary outcomes:
measure: PTSD Symptom Severity (Clinician-assessed)
timeFrame: 3 months after start of PE
measure: PTSD Diagnosis
timeFrame: 3 months after start of PE
measure: Depression
timeFrame: 3 months after start of PE
measure: Anxiety
timeFrame: 3 months after start of PE
measure: Emotional affect
timeFrame: 3 months after start of PE
measure: Satisfaction with life
timeFrame: 3 months after start of PE
measure: Mental health
timeFrame: 3 months after start of PE
Other outcomes:
measure: Suicide ideation
timeFrame: 3 months after start of PE
measure: Suicide cognition
timeFrame: 3 months after start of PE
measure: Intrusion (Clinician-assessed)
timeFrame: 3 months after start of PE
measure: Avoidance (Clinician-assessed)
timeFrame: 3 months after start of PE
measure: Cognition and mood (Clinician-assessed)
timeFrame: 3 months after start of PE
measure: Arousal and reactivity (Clinician-assessed)
timeFrame: 3 months after start of PE
measure: Intrusion (Self-report)
timeFrame: 3 months after start of PE
measure: Avoidance (Self-report)
timeFrame: 3 months after start of PE
measure: Cognition and mood (Self-report)
timeFrame: 3 months after start of PE
measure: Arousal and reactivity (Self-report)
timeFrame: 3 months after start of PE
measure: PE Initiation
timeFrame: 3 months after start of PE
measure: PE Session Completion
timeFrame: 3 months after start of PE
measure: PE Treatment Completion
timeFrame: 3 months after start of PE
measure: PE Compliance
timeFrame: 3 months after start of PE
Locations:
Study officials:
References: