Lóa Project: An Exploratory Pilot Randomised Controlled Trial of a Remotely-delivered Brief Cognitive Intervention to Reduce Intrusive Memories of Trauma for Women in Iceland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of intrusive memories of traumatic event(s)
研究概览
简要总结
Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. Previous research has demonstrated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of intrusive memories of long-standing trauma. Initial pilot work (using case studies) with women in Iceland indicates that the intervention is acceptable and feasible.
This exploratory pilot trial will compare remote delivery of the intervention (i.e. brief, digitally delivered imagery-competing task intervention, n = 12) to an attention-placebo control condition (i.e., brief, digitally delivered relaxation exercise task; n = 12). We will explore whether (relative to the control condition) the intervention: (i) reduces the number of intrusive memories (primary outcome), and (ii) improves other symptoms and functioning.
This study is funded by the OAK foundation (OCAY-18-442) and the Strategic Research and Development Program: Societal Challenges in Iceland (200095-5601).
详细描述
The proposed study will involve a brief intervention (c. 2 guided sessions with the researcher; options for up to 6 additional booster sessions) delivered digitally and remotely (i.e., not physically in-person), and with initial guided support (remotely delivered) from a researcher. Participants will be asked to fill out a diary indicating the number of intrusive memories they experienced, along with self-report questionnaires, at baseline (i.e., one week prior to commencement of the intervention), week 1 (week after the second intervention/control session), week 5 (primary outcome; 5 weeks from the second intervention/control session), and at 1-, 3- and 6-months follow-up.
Monitoring will be performed by a clinical trial unit to verify that the study is conducted and data are generated and documented in compliance with GCP and the applicable regulatory requirements.
Potentially eligible participants for this pilot study will be identified using data collected in the SAGA cohort study (an epidemiological study of trauma among Icelandic women).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged: 18-69 (at time of enrollment to cohort study)
- •Able to speak and read study materials in Icelandic or English
- •Willing to be contacted remotely and having access to a smartphone or computer
- •Experienced intrusive memories in past month (PCL-5 item 1 score is ≥ 2)
- •Experienced 2 or more intrusive memories of a traumatic event in the past week
- •Willing to monitor intrusive memories in everyday life
- •Willing and able to complete remote study sessions
排除标准
- •Suicide risk indicated in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9) and by responses on MINI during follow-up telephone risk assessment
研究组 & 干预措施
Brief cognitive task (delivered digitally)
干预措施: Brief, digitally delivered imagery-competing task intervention package, comprised of: (Behavioral)
Brief relaxation exercise task (delivered digitally)
干预措施: Brief, digitally delivered relaxation task intervention, comprised of: (Behavioral)
结局指标
主要结局
Number of intrusive memories of traumatic event(s)
时间窗: Week 5
Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days
次要结局
- Number of intrusive memories of traumatic event(s)(Baseline, Week 1, Week 12 and Week 24)
- The Posttraumatic Stress Disorder Checklist 5 (PCL-5)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The Patient Health Questionnaire-9 (PHQ-9)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The Generalized Anxiety Disorder-7 scale (GAD-7)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- Characteristics of intrusive memories(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- Impact of intrusive memories on concentration, sleep and stress(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- General impact of intrusive memories(Baseline, Week 1, Week, 5, Week 12 and Week 24)
- Impact of intrusive memories on daily functioning(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The Sheehan Disability Scale (SDS)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The Psychological Outcome Profiles; PSYCHLOPS(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- Self-rated Health rating (SRHR)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- Sleep Condition Indicator (SCI-2)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
- Time Perspective Questionnaire (TPQ)(Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups)
研究者
Andri Steinþór Björnsson
Professor
University of Iceland