Anger, Combat Related Symptoms, Irritability
Conditions
Keywords
cranial electrotherapy stimulation, anxiety, depression, pain, sleep disturbance, combat exposure, post traumatic stress, health status, medication use, soldiers
Brief summary
The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.
Interventions
PROCEDUREcranial electrotherapy stimulation (CES) with Alpha-Stim
three weeks of the cranial electrotherapy stimulation (CES) treatment (15 sessions of 60 minute treatments)
PROCEDUREplacebo
three weeks of placebo treatment via a double-blinded procedure so that neither the Soldier nor the study investigators will know whether the Soldier is receiving the actual treatment or placebo
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements. * Soldiers who score 4 or greater on the visual analog scale for irritability
Exclusion criteria
* Seizure disorders. * Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study. * Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study * Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritability Visual Analog Scale | Baseline, daily x 3 weeks, 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index | Baseline, 3 weeks, 4 weeks |
| Epworth Sleepiness Scale | Baseline, 3 weeks, 4 weeks |
| General Sleep Disturbance Scale | Baseline, 3 weeks, 4 weeks |
| Sleep Self Care Questionnaire | Baseline, 3 weeks, 4 weeks |
| Combat Exposure Scale | Baseline |
| Trauma Imagery Scale | Baseline, 3 weeks, 4 weeks |
| State - Anxiety Scale | Baseline, 3 weeks, 4 weeks |
| State Anxiety Scale | Baseline, 3 weeks, 4 weeks |
| Visual Analog | Daily x 3 weeks, 4 weeks |
| Center for Epidemiological Center for Epidemiological Studies - Depression Scale | Baseline, 3 weeks, 4 weeks |
| Depression Visual Analog | Daily x 3 weeks, 4 weeks |
| PTSD CheckList - Military Version | Baseline, 3 weeks, 4 weeks |
| Veteran's Outcomes Survey Short Form - 36 | Baseline, 3 weeks, 4 weeks |
| Medication Use Questionnaire | Baseline, 3 weeks, 4 weeks |
| Spielberger State-Trait Anger Expression Inventory-2(STAXI-2) | baseline, 3 weeks, 4 weeks |
| Profile of Mood States | Baseline, 3 weeks, 4 weeks |
Countries
United States
Outcome results
None listed