The Role of Exercise in the Treatment of PTSD Symptoms

NCT02649127 | Completed DMC

• 1 other identifier: HSC20100372H
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is an 8-week experimental, repeated-measures clinical trial randomizing 120 Service Members with symptoms of PTSD into one of four groups: 1) imaginal exercises of exposure therapy only, 2) aerobic exercise only, 3) imaginal exercises augmented with aerobic exercise, or 4) self-care.

Conditions

Posttraumatic Stress Disorder

Keywords

exercise; biomarker

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms as assessed using the PTSD Symptom Scale - Interview (PSS-I) and PTSD CheckList (PCL)

  degree of PTSD symptoms

  change in score between baseline, 1-week post-treatment, 1-month post-treatment, 6-months post-treatment

Study Arms (4)

Imaginal Therapy Only

EXPERIMENTAL

The imaginal exercise of exposure therapy will be manualized (Rothbaum, Foa \& Hembree, 2007) and adapted with the permission of Dr. Foa for combat-related stress disorders (Peterson, Cigrang \& Riggs, 2008). While traditional exposure therapy includes both imaginal exposure and in vivo exposure, this study will use only the imaginal exposure components. Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes.

Behavioral: imaginal therapy

Exercise Only

EXPERIMENTAL

The aerobic exercise regimen will be standardized according to the American College of Sports Medicine recommendations: frequency of a minimum of 5 sessions per week, at a vigorous intensity \[\>60% of oxygen uptake reserve (VO2R)\], time of 20-25 minutes per exercise session. To determine the exercise heart rate intensity, the Karvonen formula for heart rate reserve will be used. The mode of exercise will be purposeful walking or jogging. The goal of the exercise is not training, but rather to keep the participant's heart rate \>60% of their individually-determined heart rate reserve.

Behavioral: exercise

Imaginal Therapy & Exercise Combined

EXPERIMENTAL

Participants will meet with a therapist the first week of treatment and every-other week for a total of five appointments over eight weeks. During the second session, the therapist will help the participant make an approximately 20-minute voice tape recording of their traumatic experience which they will listen to 5-days/week. A new recording will be made with the therapist during sessions 3 and 4 also, for a total of three tapes. Participants will exercise listening to their tape at least 5-times/week outside of scheduled unit Physical Training. Participants will wear the heart rate monitor to record their exercise activity.

Behavioral: imaginal therapy; Behavioral: exercise

Nurse-led Self-Care

ACTIVE COMPARATOR

The Self-Care Group will use written materials that outline the benefits of thinking about problems the individual is facing as well as the benefits of exercise, however doing the two activities together will not be advocated as part of the material. A fact sheet prepared by the National Center for PTSD, Returning from the War Zone: A Guide for Military Personnel as well as a list of coping strategies and self-care behaviors adapted from the National Center for PTSD guide, Self-Care and Self-Help Following Disasters, will be used to guide the discussion. The research nurse will meet with the participant five times over 8-weeks at weeks 1, 2, 4, 6, and 8 to encourage use of the self-care fact sheet and assess the participant for safety.

Behavioral: self-care

Interventions

imaginal therapy BEHAVIORAL

imaginal exercise of Prolonged Exposure therapy

Imaginal Therapy & Exercise Combined; Imaginal Therapy Only

exercise BEHAVIORAL

aerobic training at a frequency of a minimum of 3 sessions per week, at vigorous intensity \[i. e., \>60% of oxygen uptake reserve (VO2R)\], and a time of 20-25 minutes each bout of training

Exercise Only; Imaginal Therapy & Exercise Combined

self-care BEHAVIORAL

meeting with a nurse to review and discuss publically available written materials that outline approaches for dealing with posttraumatic stress symptoms

Nurse-led Self-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be an Active Duty, Reserve, or National Guard Army, Air Force, Navy, or Marine Veteran of Operation Iraqi Freedom (OIF) / Operation Enduring Freedom (OEF) eligible for military medical care
• be at least 18 years old
• be able to read and speak English
• answer "no" to the seven questions of the Physical Activity Readiness Questionnaire (PAR-Q), or have primary care provider approval to undertake an exercise program.
• score ≥25 on the PTSD CheckList - Stressor-Specific(PCL-S); participants scoring \>50 on the PCL-S will be contacted weekly to ensure that their symptoms are under control and they do not require a higher level of care.
• report on the PTSD Symptom Scale - Interview (PSS-I) an exposure to a traumatic event (Criterion A), at least one re-experiencing symptom (Criterion B), and at least one avoidance symptom (Criterion C)
• participants taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the 1-month follow-up assessment as much as possible and as medically indicated
• anticipate being in the area for at least three months to complete intervention and 13-week follow-up assessment

You may not qualify if:

• score \<25 on the PTSD CheckList - Stressor Specific (PCL-S) (Those scoring \<25 do not have enough symptom severity to adequately test the study hypotheses
• have undergone exposure therapy for PTSD within the last year
• be taking benzodiazepines every day on a prescribed schedule (Individuals prescribed and taking a benzodiazepine only as needed will not be excluded.)
• suicidal ideation with moderate to severe intent warranting intervention
• active psychosis or mania
• be on a medical profile that prohibits exercise

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• C.R.Darnall Army Medical Center: collaborator

Study Sites (1)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Links

• STRONG STAR Consortium web link describing study

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Implosive Therapy; Exercise; Self Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stacey Young-McCaughan, RN, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 7, 2016
• Study Start: February 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2016-09

Locations

US (1)