A Brief Intervention for PTSD Versus Treatment as Usual: Study Protocol for a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.
详细描述
Background: Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting lines, avoidant tendencies, shame and stigma, potentially leading to fewer people seeking therapy or premature dropouts. A potential solution to battling these barriers is Brain Working Recursive Therapy (BWRT), a single-session intervention for PTSD. Although not yet subjected to empirical investigation, clinical experiences suggest an often immediate and long-lasting effect following the intervention related to patient's symptomatology and functional abilities.
Methods: The current study protocol outlines a plan to conduct the first non-inferiority randomized controlled trial aimed to explore the efficacy of BWRT compared to treatment as usual (TAU). Eighty-two participants will be allocated at a 1:1 ratio to one of the following treatment conditions: (1) BWRT or (2) treatment as usual. Participants will be compared on several variables, including changes in PTSD symptoms (primary objective), and changes in perceived quality of life, rumination, functional and cognitive ability (secondary objective). Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Discussion: Should BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have experienced at least one traumatic experience throughout their lifetime
- •Participants must meet the DSM-5 criteria for PTSD, or subthreshold PTSD
- •The following DSM-5 criteria must be fulfilled:
- •A (exposure to traumatic stressor),
- •in addition to three out of four of the following symptom-clusters;
- •B (intrusion),
- •C (avoidance),
- •D (negative alterations in cognitions and mood),
- •E (alterations in arousal and reactivity)
- •A marked decline in functioning and symptom persistence for over a month
排除标准
- •ongoing psychotic disorders, or a history of psychosis,
- •severe suicidal ideation,
- •bipolar disorder,
- •BMI index too low to benefit from psychological interventions,
- •severe alcohol or substance dependence,
- •serious somatic illness or brain damage,
- •participation in concurrent psychotherapy.
研究组 & 干预措施
BrainWorking Recursive Therapy
Brief intervention for PTSD- single session (BWRT)
干预措施: BrainWorking Recursive Therapy (Behavioral)
Treatment as usual
Treatment as usual with evidence-based therapy for PTSD provided within the Norwegian health care system and adhering to the National Institute for Health and Care Excellence (NICE) guidelines for treating PTSD
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).
Changes in PTSD symptoms A total severity score for PTSD symptoms will established based on the summed severity of each symptom, with scores ranging from 0-80. Higher score defines higher severity.
次要结局
- The Satisfaction with Life Scale (SWLS)(Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).)
- Ruminative Responses Scale (RRS)(Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).)
- Work and Social Adjustment Scale (WSAS)(Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).)
- Perceived Deficits Questionnaire-Depression, 5-item (PDQ-D5)(Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3).)
研究者
Aasa Karin Hammar
Professor
University of Bergen