Clinical trial NCT02030522: Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma
Official title: Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Keywords: Post-traumatic stress disorder
PTSD
Accelerated Resolution Therapy
Military
Veterans
Exposure therapy
Eye movements
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 17-item PTSD Checklist-Military (PCL-M)
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
Secondary outcomes:
measure: Brief Symptom Inventory
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Clinical Outcomes in Routine Evaluation
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Medical Outcome Study Short Form-36 (SF-36)
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: State-Trait Inventory for Cognitive and Somatic Anxiety
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Trauma-Related Guilt Inventory
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Pain Outcomes Questionnaire
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
measure: Psychiatric Diagnostic Screening Questionnaire
timeFrame: Change from pre-treatment to post-treatment and 6-month follow-up
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Homeless Emergency Project (HEP)
state: Florida
city: Holiday
country: United States
facility: Veterans Alternative Therapy Center
state: Florida
city: Jupiter
country: United States
facility: Life Renewal Counseling
state: Florida
city: Land O' Lakes
country: United States
facility: Pasco County Detention Center
state: Florida
city: New Port Richey
country: United States
facility: Supportive Services for Veterans Families
state: Florida
city: Orlando
country: United States
facility: Gilstrap & Associates
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Auburn
country: United States
facility: Cornerstone Counseling
state: Maine
Study officials:
affiliation: University of South Florida
name: Kevin E Kip, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kip KE, Sullivan KL, Lengacher CA, Rosenzweig L, Hernandez DF, Kadel R, Kozel FA, Shuman A, Girling SA, Hardwick MJ, Diamond DM. Brief treatment of co-occurring post-traumatic stress and depressive symptoms by use of accelerated resolution therapy((R)). Front Psychiatry. 2013 Mar 8;4:11. doi: 10.3389/fpsyt.2013.00011. eCollection 2013.
citation: Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014.
citation: Kip KE, Shuman A, Hernandez DF, Diamond DM, Rosenzweig L. Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Mil Med. 2014 Jan;179(1):31-7. doi: 10.7205/MILMED-D-13-00229.
citation: Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Sullivan KL, Long CJ, Taylor J, McGhee S, Girling SA, Wittenberg T, Sahebzamani FM, Lengacher CA, Kadel R, Diamond DM. Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD). Mil Med. 2013 Dec;178(12):1298-309. doi: 10.7205/MILMED-D-13-00298.