Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study.

BACKGROUND: Many veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions. This implies complex physical and psychosocial problems for veterans and their families. Treatment options today are primarily medically and psychologically founded but treatment response is incomplete. Body therapy for PTSD is scarcely researched though subject of increased attention. In 2015, a Danish pilot study was conducted exploring body therapy for PTSD. The study showed positive results and formed basis for a randomised controlled trial. This paper outlines the protocol for this trial. METHODS: The intervention will be evaluated in a two-arm randomised controlled trial (1:1). The trial will include 42 veterans with PTSD recruited by the Danish Military Psychiatric Centre. The intervention group receives treatment as usual and weekly body therapy treatment as add-on. The control group receives treatment as usual (TAU). Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline. Linear regression models and mixed effects models will be used to assess intervention effects. Furthermore, an ethnographic study will examine how the participants experience the treatment and changes in their everyday life. The ethnographic study is based on in-depth interviews, participant observations and focus groups. A mixed method, convergent parallel design will be applied. DISCUSSION: This study examines the efficacy of body therapy for veterans with PTSD and how the treatment is experienced and affects daily life. The study will contribute with important knowledge on an alternative treatment for PTSD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03777800.

[Diagnosing and treating post-traumatic stress disorder].

The post-traumatic stress disorder (PTSD) diagnosis has undergone large developments. With the changes in DSM-5 and the proposed changes in ICD-11, the two systems move in different directions. Treatment for PTSD is developing, but the evidence for the effect is lacking behind. Trauma-focused cognitive behavioural therapy and eye movement desensitization and reprocessing remain first choice. Pharmacotherapy is secondary. There is evidence for the effect of paroxetine, venlafaxine and fluoxetine and less so for sertraline.

Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia.

OBJECTIVE: To directly compare aripiprazole once-monthly 400mg (AOM 400) and paliperidone palmitate once-monthly (PP) on the Heinrichs-Carpenter Quality-of-Life Scale (QLS), a validated health-related quality of life and functioning measure in schizophrenia. METHOD: This 28-week, randomized, non-inferiority, open-label, rater-blinded, head-to-head study (QUALIFY) of AOM 400 and PP in adult patients (18-60 years) comprised oral conversion, initiation of AOM 400 or PP treatment, and continuation with intramuscular injections every 4weeks. The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements. RESULTS: Of 295 randomized patients, 100/148 (67.6%) of AOM 400 and 83/147 (56.5%) of PP patients completed 28weeks of treatment. A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score (4.67 [95%CI: 0.32;9.02], p=0.036) confirmed non-inferiority and established superiority of AOM 400 vs PP. There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator's Assessment Questionnaire for AOM 400 vs PP, and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years. Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400, and adverse events were the most frequent reason for discontinuation (27/137 [19.7%] for PP and 16/144 [11.1%] for AOM 400). All-cause discontinuation was numerically lower with AOM 400. CONCLUSION: Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate. ClinicalTrials.gov identifier:NCT01795547.

Use of health care services before and after a natural disaster among survivors with and without PTSD.

OBJECTIVE: This study used a questionnaire to identify individuals who met criteria for posttraumatic stress disorder (PTSD) ten months after surviving a disaster and compared their use of health care services before and after the disaster with that of survivors who did not meet criteria for PTSD. METHODS: Ten months after the December 26, 2004, Southeast Asian tsunami, Danish tourists who had been in areas exposed to the disaster were mailed a questionnaire asking about demographic characteristics and exposure to the tsunami. The questionnaire included the PTSD Checklist, which measures symptoms of posttraumatic stress. Individuals who met DSM-IV PTSD criterion A1--in this case, being caught, touched, or chased by the waves or having witnessed the death, serious injury, or suffering of others--were included in the analyses (N=635). The Danish National Health Service Register provided longitudinal data on annual number of contacts with health care services before (2002-2004) and after (2005-2007) the tsunami. RESULTS: Survivors with PTSD or partial PTSD used health care services more than survivors without PTSD before and after the tsunami. The severity of posttraumatic stress symptoms was positively correlated with postdisaster use of health care services. However, when adjusted for predisaster health care use, this association was not significant. CONCLUSIONS: Postdisaster health care service utilization was predicted by predisaster health care service utilization and was hardly affected by the onset of PTSD itself. Associations between PTSD and subsequent health problems must be interpreted with caution.

Exposure characteristics and peri-trauma emotional reactions during the 2004 tsunami in Southeast Asia--what predicts posttraumatic stress and depressive symptoms?

This study examined the impact of disaster-related stressors and peri-trauma emotional reactions on mental health 10 months after the 2004 Southeast Asian tsunami disaster in a sample of 660 Danish tourists evacuated from the disaster area. The estimated rates of posttraumatic stress disorder and depression were 10.2% and 6.4%, respectively. The strongest predictors of posttraumatic stress and depressive symptoms were peri-trauma fear and dissociation. Among exposure variables, only witnessing others suffering was associated with both these disorders, whereas loss of family members and history of psychiatric treatment emerged as independent risk factors for depression. These variables explained a smaller proportion of variance in posttraumatic stress symptoms. These findings contribute to a body of evidence showing the critical role that appraisal of trauma plays in posttraumatic stress disorder and depression.

The course of adjustment disorder in Danish male conscripts.

Conscription has been employed for more than a century. To evaluate the course and fate of conscripts deemed mentally unfit for immediate continued service, a prospective questionnaire study of conscripts referred for mental evaluation was conducted. Questionnaires were completed at the time of enrollment, time of admittance for evaluation, time of discharge from their evaluation and at 1-year follow-up. Out of a class of 6949 conscripts, 93 were referred for psychiatric evaluation and 69 of those referred decided to enter the study (60 of these were in time deemed unfit for further military service). At the time of admittance, on average after 79 days of service, there was a significant 36%, 34%, 20% and 20% increase in depression, sleep, somatization and interpersonality scores, respectively. At the time of discharge 14 days after admittance, the symptom scores had dropped to a level comparable to scores at the time of enrollment. At 1-year follow-up, the descending trend in scores was maintained, though not reaching statistical significance compared with scores at time of discharge. The scores at 1-year follow-up were also, except for a higher depression score, comparable with the scores of a control group of conscripts evaluated 1 year after service. The psychological profile of conscripts referred for evaluation was different at the time of enrollment compared with conscripts in general, the scores being between 9% (interpersonality) and 29% (depression) higher. They also had a higher prevalence of adverse family events in their history. The course observed is indifferent from other situations of enforced stress.