Post-Traumatic Stress Disorder (PTSD) is a common sequelae of severe emotional trauma that is often associated with combat exposure. PTSD has significant implications for quality of life in afflicted veterans, defined by the U.S. Veteran Administration as persons who have served in the active U.S. military, naval or air force and who have been honorably discharged or released. Almost half of all U.S. male Vietnam veterans with current PTSD have been arrested or jailed at least once, 34.2% more than once, and 11.5% had been convicted of a felony [1]. Day-to-day functioning is also adversely impacted by PTSD as indicated in Breslau et al. [2] who found that individuals with full PTSD, compared to those with partial PTSD, demonstrated greater impairment in terms of work days lost, interference with work or daily activities, decreased time spent with people in personal life, and increased conflicts with others because of their reactions to the traumatic experience [3].
PTSD places a particularly significant burden on interpersonal relationships resulting in loneliness and isolation, which may further intensify psychiatric symptoms. Research from the National Co-morbidity Study, for example, indicate that although those with PTSD have the same likelihood as those without PTSD to be married at any point in time, they are 3 to 6 times more likely to divorce. [4] Similarly, about one-third of Veterans with PTSD engaged in intimate partner violence over the one-year observation period compared to 13.5% among veterans without PTSD [4].
Current treatment options for PTSD include psychotherapy, medication management, or both in combination. Psychotherapy approaches with the strongest demonstrated efficacy include cognitive behavioral therapies such as prolonged exposure therapy, stress inoculation training, cognitive processing therapy, eye movement desensitization and reprocessing, and several combinations of these procedures [5,6,7,8,9,10,11]. Among the many medications available, none is uniformly successful and all have side effects, underscoring the need for adjuvant means of symptom control that patients can incorporate into a self-management strategy for long term use. Recognizing such need, the U.S. Veterans Administration and the Department of Defense have released a practice guideline stating that Complementary and Alternative Medicine (CAM) may “facilitate engagement in medical care and may be indicated for some patients who refuse evidence-based treatments.”
A number of studies, including five randomized controlled trials, have examined the efficacy of music as a complementary therapy in the treatment of mental illnesses. A recent review [12] indicated that several studies have found greater reductions in symptoms of depression among patients who received music therapy versus standard care for depression [13,14,15,16]. To date, however, no published study has examined the effect of an active music-instruction intervention as a complementary strategy to improve the psychological well-being of veterans with PTSD [1].
Filling in this knowledge gap, the purpose of this pilot study was to examine the feasibility and potential effectiveness of an active, music-instruction intervention at improving psychological health and social functioning among a high-risk population of Veterans suffering from moderate to severe PTSD. We hypothesize that the intervention would decrease Veterans’ PTSD symptomatology, which was the outcome measure of most interest. We also posited that depression and perception of cognitive difficulties would be lessened, and that social functioning and health-related quality of life would be improved.
Data and methods
Study population
The study population consisted of veterans receiving routine care for PTSD symptoms at the Zablocki VA Medical Center in Milwaukee, WI. Eligible Veterans were those who (i) had at least one visit for mental health treatment in the prior six months with a primary diagnosis of PTSD (ICD9CM 309.81–83) and (ii) exhibited moderate to severe PTSD symptoms at the time of enrollment (Posttraumatic Stress Disorder Checklist > = 50) [17]. Veterans were excluded from the study if they were currently participating in an intense psychotherapy program (residential or outpatient) or if they were already receiving guitar lessons from a Guitars for Vets volunteer.
Recruitment
Eligible subjects were informed about the study while attending PTSD-related programming via IRB-approved informational flyers that included contact information for study participation. In addition, veterans receiving non-residential services at the VA Domiciliary facility could self-refer to the program, provided that they were not involved in a residential treatment program for PTSD. Eligibility was determined from evidence of PTSD diagnosis from medical records. Finally, a postcard was mailed inviting study participation to potentially eligible veterans who had been identified through the VA medical record system as having a diagnosis of PTSD or who had visits to mental health providers over the past six months. All Veterans that enrolled in the study gave written consent prior to participation.
The intervention
This research project took advantage of an established partnership between the Zablocki VA in Milwaukee WI and Guitars for Vets, a 501(c)(3) non-profit organization providing Veterans receiving treatment at Veteran’s Administration facilities with guitar instruction by professional music teachers. The intervention was designed as an active intervention and provided veterans with an acoustic guitar, guitar pick and tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a six-week intervention period. Six tailored one-hour individual guitar instruction sessions were scheduled (one session per week for six weeks). In addition to the six Veteran-centered, tailored individual lessons, the intervention provided three group sessions. Veterans were given a guitar that they could keep upon completion of the training program. Sessions were offered in the late afternoon and early evenings at the Zablocki VA Domiciliary, which provided an excellent non-clinical environment with ample room for such activities. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.
Study design
This was a prospective, delayed-entry randomized pilot trial of 40 subjects. Given its pilot nature, a formal power calculation was not performed, although it was estimated that 40 subjects would enable us to detect a 15% or higher reduction between pre-post PCLC scores with 80% power at α = 0.05. The study design is depicted in Fig. 1 with the associated CONSORT flow diagram depicted in Fig. 2. Enrollment occurred after the research associate had completed the initial eligibility assessment and consent. Following eligibility determination and consent process, Veterans were interviewed in-person by a trained interviewer, using a structured survey. Veterans were then randomized to either (1) immediate entry or (2) delayed entry intervention arm using a 2:1 ratio in order to maximize the number of subjects immediately eligible to receive the intervention. In addition, given the expected higher attrition among Veterans randomized to the delayed entry group, the wait period for was set to 4 weeks.
The intervention content and duration was the same across both groups. Following the baseline interview (A), veterans randomized to the immediate entry group directly engaged in the intervention described above and were interviewed at the end of the intervention period (B), roughly 6 weeks later. Those randomized to the delayed entry group had their baseline interview (X) repeated at the end of the delayed entry period (A1) prior to receiving the 6-week intervention as well as after intervention completion (B1). This approach enabled us to ascertain the natural history and temporal variation in PTSD symptoms.
Variable definitions and measurement
The primary outcome was PTSD symptoms as measured by the PTSD Checklist Civilian (PCLC) [17, 18], a self-report scale that measures PTSD presence and severity. The 17 items correspond to Diagnostic and Statistical Manual DSM-IV symptoms of PTSD. The level of distress produced by each symptom is rated from 1 (not at all) to 5 (extremely). A score > 50 on this measure is considered clinically significant (maximum score = 85). The PCLC has been shown to have good reliability and convergent validity [17].
Secondary outcomes were depression, perceptions of cognitive failures, social functioning, and health-related quality of life. Depression was assessed using the Beck Depression Inventory-II (BDI-II), [19] a 21-item self-report scale measuring the presence and severity of depressive symptoms over the two weeks preceding test administration. Each answer ranges in score from 0 to 3. Total scores indicate minimal (0–13), mild (14–19), moderate (20–28), and severe (29–63; maximum = 63) levels of reported depression. The Cognitive Failures Questionnaire (CFQ) [20] was used as a self-reported measure of everyday cognitive lapses for perception, memory, and motor function, such as forgetting appointments or having word finding difficulty. The CFQ has been applied on diverse neurological and medical populations and has been shown to have appropriate psychometric properties [20]. The UCLA Loneliness Scale [21] was administered to assess subjective feelings of social isolation. The measure has established reliability and has been shown to correlate well with other measures of loneliness, and to discriminate between feelings of loneliness and depression. Finally, the EuroQoL, [22] a validated preference-based scale for which population norms are available in the US and elsewhere, was used as the global evaluation of veteran’s health-related quality of life. The EuroQoL measure combines data on activity restrictions (ADL, IADL limitations), limitations in participation (usual major activity and other social activities) and self- perceived health status (excellent, good, fair or poor) to measure one’s overall satisfaction with health and well-being.
Information was collected about the veteran’s sociodemographic and economic characteristics, including age, gender, race/ethnicity, marital status, number of children, household size, major activity/work status. These data were used to examine possible confounding variables and to control for chance differences across samples randomized to immediate and delayed entry.
Statistical analysis
Descriptive statistics were used to characterize the participant population and to contrast the delayed and immediate entry groups using standard t and χ2 test statistics. The main analyses, however, relied on regression-adjusted difference in means to ascertain the independent effect of the Guitar for Vets intervention on PTSD symptoms, depression, social functioning and quality of life. Specifically, we applied the Generalized Estimation Equation (GEE) [23, 24] regression technique to estimate intervention impacts by comparing the post-intervention experience of the entire sample (immediate + delayed entry groups) to the delay period experience (no intervention) of the delayed entry group (referred as “control” group). These GEE regressions, which adjusted for baseline levels of each outcome of interest as well as variables found to differ by chance across randomized groups, enabled us to account both for specific time-invariant effects and design clustering (repeated observations for delayed entry group veterans). Estimates of treatment-control group differences generated by these models were then tested for statistical significance to determine the intervention effectiveness of two equally motivated groups, one of which was not yet receiving active treatment.