Trial Outcomes & Findings for Mantram Repetition to Manage PTSD in Veterans (NCT NCT00120627)

Recruitment began in January 2006 and ended in December 2009. Participants were recruited from PTSD outpatient clinics and other primary care clinics in the VA system in southern California.

There were 4 subjects who dropped after random assignment and before entering the interventions. Two had scheduling conflicts and could not attend the groups at the time they were offered. One was too ill. The other did not have a reason.

Mantram Repetition to Manage PTSD in Veterans

The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0="never" to 4="daily or almost everyday." The items for intensity are rated from 0="none" to 4="extreme." Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis. The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.

The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0="not at all" to 5="extremely". Higher scores indicate greater severity and scores range from 17-85.

Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include "feeling calm and peaceful, having alot of energy, feeling downhearted and blue" -- all rated on a frequency scale from 1= "all of the time" to 6="none of the time." Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) "accomplishing less than you like" and (2) "not doing work or activies as carefully as usual" (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements.

FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of "feeling peaceful," "having meaning and purpose in life" and "finding comfort in faith or spiritual beliefs." Items are rated on a 5-point Likert scale: 0 = "not at all" and 4 = "very much". Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being.

The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.

Quality of Life Enjoyment \& Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.

The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.

Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.

Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.

Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.