Prolonged exposure therapy and supportive counselling for posttraumatic stress disorder in adolescents in a community-based sample, including experiences of stakeholders: study protocol for a comparative randomized controlled trial using task-shifting

针对社区样本中青少年创伤后应激障碍的延长暴露疗法和支持性咨询,包括利益相关者的经验:一项采用任务转移的比较随机对照试验的研究方案

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Abstract

BACKGROUND: There is a dearth of empirical evidence on the effectiveness of pharmacological and non-pharmacological treatments for adolescents with posttraumatic stress disorder (PTSD) in developing countries. The primary aim of the study is to examine the effects of prolonged exposure therapy compared with supportive counseling for adolescents with PTSD delivered by nurses trained as counselors. METHODS/DESIGN: A single-blind randomized clinical trial comprising 90 adolescents with PTSD using a permuted block design will be utilized. Nurses previously naïve to prolonged exposure and supportive counselling will be trained to provide these treatments at the adolescents' high schools. Data collection will last from March 2014 to December 2017 and annually thereafter, dependent on the availability of funding. Participants will receive seven to fourteen 60 min sessions of prolonged exposure treatment (n = 45) or supportive counselling (n = 45). All assessments will be conducted before treatment, at mid-treatment, immediately after treatment completion, at 3-, 6-, and 12-month follow-up, and annually thereafter. It is hypothesized that PE-A will be superior to SC in reducing PTSD symptoms at post-treatment as measured by the CPSS-I administered by an independent evaluator. It is further hypothesized that PE-A treatment gains will be maintained at 3-, 6- and 12-month follow-ups and annually thereafter. DISCUSSION: While early indications are that PE-A is an effective treatment for PTSD in adolescents, this study will help determine the effectiveness of PE-A in a South African, community setting (school-based) when task-shifted to nurses, as compared to SC. TRIAL REGISTRATION: Pan African Clinical Trials Registry: PACTR201511001345372 , retrospectively registered 11 November 2015.

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