IMPORTANCE Despite the high prevalence, evidence-based treatments for abuse-related posttraumatic stress disorder (PTSD) in adolescents have rarely been studied. OBJECTIVE To examine whether developmentally adapted cognitive processing therapy (D-CPT) is more effective than a wait-list condition with treatment advice (WL/TA) among adolescents with PTSD related to childhood abuse. DESIGN, SETTING, AND PARTICIPANTS This rater-blinded, multicenter, randomized clinical trial (stratified by center) enrolled treatment-seeking adolescents and young adults (aged 14-21 years) with childhood abuse-related PTSD at 3 university outpatient clinics in Germany from July 2013 to June 2015, with the last follow-up interview conducted by May 2016. Of 194 patients, 88 were eligible for randomization. INTERVENTIONS Participants received D-CPT or WL/TA. Cognitive processing therapy was enhanced by a motivational and alliance-building phase, by including emotion regulation and consideration of typical developmental tasks, and by higher session frequency in the trauma-focused core CPT phase. In WL/TA, participants received treatment advice with respective recommendations of clinicians and were offered D-CPT after 7 months. MAIN OUTCOMES AND MEASURES All outcomes were assessed before treatment (baseline), approximately 8 weeks after the start of treatment, after the end of treatment (posttreatment), and at the 3-month follow-up. The primary outcome, PTSD symptom severity, was assessed in clinical interview (Clinician-Administered PTSD Scale for Children and Adolescents for DSM-IV [CAPS-CA]). Secondary outcomes were self-reported PTSD severity, depression, borderline symptoms, behavior problems, and dissociation. RESULTS The 88 participants (75 [85%] female) had a mean age of 18.1 years (95% CI, 17.6-18.6 years). In the intention-to-treat analysis, the 44 participants receiving D-CPT (39 [89%] female) demonstrated greater improvement than the 44 WL/TA participants (36 [82%] female) in terms of PTSD severity (mean CAPS-CA scores, 24.7 [95% CI, 16.6-32.7] vs 47.5 [95% CI, 37.9-57.1]; Hedges g = 0.90). This difference was maintained through the follow-up (mean CAPS-CA scores, 25.9 [95% CI, 16.2-35.6] vs 47.3 [95% CI, 37.8-56.8]; Hedges g = 0.80). Treatment success was greatest during the trauma-focused core phase. The D-CPT participants also showed greater and stable improvement in all secondary outcomes, with between-groups effect sizes ranging from 0.65 to 1.08 at the posttreatment assessment (eg, for borderline symptoms, 14.1 [95% CI, 8.0-20.2] vs 32.0 [95% CI, 23.8-40.2]; Hedges g = 0.91). CONCLUSIONS AND RELEVANCE Adolescents and young adults with abuse-related PTSD benefited more from D-CPT than from WL/TA. Treatment success was stable at the follow-up and generalized to borderline symptoms and other comorbidities. TRIAL REGISTRATION German Clinical Trials Register identifier: DRKS00004787
BackgroundProlonged grief disorder (PGD) has emerged as a well-defined and relatively common mental disorder that will be included in the upcoming revision of the International Classification of Diseases. Recent trials with grief-specific, mostly cognitive behavioral interventions for patients with a clinically relevant diagnosis of PGD showed large effect sizes. However, a small trial suggested that non-specific behavioral activation might suffice to improve PGD. So, more evidence for the relative efficacy of grief-specific treatments is needed, as is more research on the predictors of treatment success. The purpose of the proposed trial is to evaluate a newly developed and successfully pilot-tested, prolonged grief-specific, integrative cognitive behavioral therapy (PG-CBT) compared to an active yet unspecific treatment, present-centered therapy (PCT).MethodsIn a multicenter, randomized controlled trial with 204 adults with a primary diagnosis of PGD, PG-CBT is compared to PCT, assuming the superiority of PG-CBT. Both treatments consist of 20 to 24 individual sessions, with an overall treatment length of about 6 months. The primary outcome, grief symptom severity, is assessed by blinded interviewers 12 months after randomization. Secondary outcomes are grief symptom severity at post treatment, in addition to self-reported overall mental health symptoms, depressive and somatoform symptoms at post treatment and 12 months post randomization. Possible moderators and mediators of treatment success are also explored.DiscussionThe trial is designed to avoid bias as much as possible (stratified randomization performed independently, blinded outcome assessment, intention-to-treat-analysis, balanced treatment dose, continuous supervision, control for allegiance effects) thereby enhancing internal validity. At the same time, some aspects of the trial will ensure clinical relevance (recruiting at outpatient clinics that are part of routine health care and keeping exclusion criteria to a minimum). Since the trial is powered adequately for the primary outcome, all secondary analyses including moderator analyses are exploratory by nature. The results will extend the knowledge on efficacious treatment of PGD and its predictors.Trial registrationGerman Clinical Trials Register, ID: DRKS00012317. Registered on 6 September 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2618-3) contains supplementary material, which is available to authorized users.
Background: Posttraumatic stress disorder (PTSD) is one of the psychopathological consequences of sexual and/or physical abuse. The economic burden is assumed to be high, whereas health-related quality of life and education is negatively affected. This study aims to determine health care costs, health-related quality of life, and educational interruption in adolescents and young adults with PTSD after sexual and/or physical abuse in Germany. Methods: This analysis used data of 87 participants aged 14-21 years of a randomized controlled trial. Health care utilization, health-related quality of life (EQ-5D-5L), sick leave days, productivity, and delay or failure to achieve educational aims were assessed. Health care costs from a payer perspective were calculated using unit costs for the year 2014. Results: Mean health care costs for a six-month period were 5,243€ (SE 868€). In particular, costs of inpatient stays in psychiatric hospitals, general hospitals and rehabilitation as well as child welfare institutions were high. In addition, health-related quality of life was lower due to anxiety/depression, resulting in a mean EQ-5D index and EQ-VAS score of 0.70 and 61.0, respectively. Furthermore, participants reported on average 27 sick leave days, a productivity loss of 61%, and a delay in education attainment as well as having been unable to achieve educational aims. Conclusion: PTSD in adolescents and young adults is associated with a high economic burden. Health-related quality of life was substantially reduced. Furthermore, delay and productivity losses in education were observed.
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