Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma

University of South Florida

Status: Completed

Conditions: Post-traumatic Stress Disorder (PTSD)

Treatments: Behavioral: Accelerated Resolution Therapy (ART)

Study type: Interventional

Funder types: Other

Identifiers

NCT02030522

Pro00013717

Details and patient eligibility

About

This is a prospective cohort treatment intervention study (n=200) whereby U.S. service members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by Florida licensed mental health professionals trained in ART. The 3 study aims are to: (i) evaluate among U.S. service members and veterans overall, and within specific subgroups, the magnitude of change in symptoms of PTSD following treatment with ART; (ii) evaluate the sustainability of treatment response with ART; and (iii) evaluate the cost effectiveness of ART compared to prolonged exposure (PE) therapy in the treatment of symptoms of PTSD.

Full description

This study entitled "Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma" is a prospective cohort treatment intervention study (n=200) whereby U.S. service members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by Florida licensed mental health professionals trained in ART. Clinical assessments will be conducted pre-treatment, post-treatment (approximately 2 weeks after study entry), and at 6-month follow-up (self-report questionnaires). The study aligns with the USF College of Nursing POWER initiative by seeking to expand the science base of effective treatment of service members and veterans with impaired psychological status. The study rationale is to: (i) demonstrate that ART is a brief, effective, and safe treatment for military-related PTSD including military sexual trauma (MST) and among service members with PTSD refractory to previous psychotherapy; (ii) provide evidence of the sustainability of clinical response 6-months after treatment completion; (iii) provide evidence that ART is a cost effective treatment for PTSD compared to current therapies formally endorsed by the VA and DoD; and (iv) develop the infrastructure for expansion of the ART protocol and science base, including national and international treatment settings, expanded patient populations, expanded clinical services, and mechanistic studies of ART. The target population (n=200) will consist of U.S. service members and veterans who have symptoms indicative of a current diagnosis of PTSD. Oversampling will occur for participants with a history of MST (minimum n=60) and/or PTSD refractory to prior psychotherapy (minimum n=60). No age limit or duration of symptoms of PTSD will be imposed for study eligibility, and it is anticipated that most, if not all, of eligible and enrolled participants will have had prior deployments to conflicts dating back to the 1970s, including the Vietnam War, Persian Gulf War, and the more recent wars in Iraq and Afghanistan. Demographic and medical history data will be collected along with details of prior military service including service branch, deployment location(s) and type of trauma(s). Participants will complete the 7-item Combat Exposure Scale and 3-item Brief Traumatic Brain Injury Screen. To evaluate treatment response, measures completed at entry, post-treatment, and 6 months will include: 17-item PCL-M (PTSD Checklist), 125-item Psychiatric Diagnostic Screening Questionnaire, 18-item Brief Symptom Inventory (BSI), 34-item Clinical Outcomes in Routine Evaluation (CORE-OM) scale, Medical Outcome Study Short Form-36, 20-item Center for Epidemiological Studies Depression Scale (CES-D), 21-item State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA), 22-item Trauma-Related Guilt Inventory (TRGI), and use of medications. The study will be conducted over a 24-month period.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• U.S. service member or veteran with prior deployment(s) to a major conflict zone(s)(e.g. Vietnam War, Persian Gulf conflict, and wars in Iraq and Afghanistan).
• Symptoms indicative of current PTSD. This includes: (i) score of >40 on the PCL-M Checklist; (ii) endorsement of PCL-M symptoms rated as "Moderately" or above as follows: at least 1 B item (questions 1-5), 3 C items (questions 6-12), and at least 2 D items (questions 13-17); and (iii) scoring positive on the PTSD subscale of the Psychiatric Diagnostic Screening Questionnaire.
• Ability to read and speak English to complete survey questions.
• Denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis.

Exclusion criteria

• Brain injury prohibiting speech, writing, and purposeful actions.
• Currently engaged in another PTSD psychotherapy treatment intervention. Screening therapist will determine eligibility based on the type of psychotherapy and medications the participant is receiving.
• Major psychiatric disorder (e.g. bipolar disorder) concomitant to symptoms of psychological trauma and deemed likely to interfere with treatment delivery.
• Currently undergoing substance abuse treatment (alcohol and/or drug).
• Any medical condition that, in the judgment of the Principal Investigator and/or ART clinician, may place the individual at high risk due to a potential heightened emotional reaction (e.g. previous heart attack, seizure disorder).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

155 participants in 1 patient group

Prospective Treatment Cohort of ART

Experimental group

Description:

The target population (n=200) of persons treated with the intervention, Accelerated Resolution Therapy, will consist of U.S. service members and veterans who have symptoms indicative of a current diagnosis of PTSD. No age limit or duration of symptoms of PTSD will be imposed for study eligibility, and it is anticipated that most, if not all, of eligible and enrolled participants will have had prior deployments to conflicts dating back to the 1970s, including the Vietnam War, Persian Gulf conflict, and wars in Iraq and Afghanistan. No person will be excluded on the basis of race, ethnicity, gender, or disability.

Treatment:

Behavioral: Accelerated Resolution Therapy (ART)