The Lóa Study: A Randomised Control Trial of a Brief Digital Intervention to Support Women Experiencing Intrusive Memories of Traumatic Events During Their Lifespan From the SAGA Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 380
- 试验地点
- 2
- 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, and can evoke strong emotions and disrupt functioning in daily life. Previous research has indicated 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 and a pilot study, ClinicalTrials.gov identifier: NCT05089058) with women in Iceland indicates that the intervention is acceptable and feasible.
This randomised controlled trial will compare 3 arms to investigate if access to a cognitive task - either a brief self-guided imagery-competing task or a brief self-guided psychoeducation and signposting task - versus treatment as usual, can reduce the number of intrusive memories in week 5 (i.e., between-groups comparison), controlling for the number of intrusive memories in the baseline week.
The effect on the number of intrusive memories in week 5 (primary outcome), and other symptoms of post-traumatic stress, sleep and cognitive functioning will be tested.
This study is funded by the Icelandic Research Fund (11709-0270) and (200095-5601) and The Oak Foundation (OCAY-18-442).
详细描述
Participants will be recruited from the Stress and Gene Analysis (SAGA) Cohort, a population-based, longitudinal study of Icelandic women (www.afallasaga.is, see selected publications in the reference box below).
A statistical analysis plan will be prepared prior to the first interim analysis using both frequentist and Bayesian analyses for statistical inference.
Regular monitoring will be performed by Vistor to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, good clinical practice (GCP) and the applicable regulatory guidelines.
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 73 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Part of the SAGA cohort
- •Aged 18 or above.
- •Able to read, write and speak in Icelandic.
- •Have internet access.
- •Willing to be contacted remotely and having access to a smartphone or computer
- •Experience 3 or more intrusive memories in the past week
- •Willing to monitor intrusive memories in everyday life
- •Willing and able to provide informed consent and complete study procedures
- •Willing and able to be contacted by the research team during the study period.
- •Have not taken part in a previous study of this intervention from this research team (e.g., the Loa case series, feasibility trial or pilot RCT).
排除标准
- •Have fewer than three intrusive memories during the baseline week.
- •Suicide risk in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9).
- •Those undergoing other treatments for post-traumatic stress disorder (PTSD) or its symptoms will not be excluded, so the study will be as inclusive as possible.
研究组 & 干预措施
Brief imagery-competing task
Access to a brief imagery-competing task for 24 weeks (with optional researcher support during the study)
干预措施: Brief imagery-competing task (Behavioral)
Brief psychoeducation and signposting task
Access to psychoeducation and signposting regarding resources for psychological trauma in Iceland for 24 weeks (with optional researcher support during the study)
干预措施: Brief psychoeducation and signposting task (Behavioral)
Treatment as usual (TAU)
Routine care that participants would otherwise receive if having intrusive memories of traumatic events.
干预措施: Treatment as usual (TAU) (Other)
结局指标
主要结局
Number of intrusive memories of traumatic event(s)
时间窗: Week 5 (all arms) controlling for run-in/baseline week
The number of intrusive memories of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days.
次要结局
- Number of intrusive memories of the traumatic event(s)(Week 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week)
- The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)(Baseline, week 5, week 12 and week 24 follow-ups)
- The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Baseline, week 5, week 12 and week 24 follow-ups)
- Cognitive Functions Scale(Baseline, week 5, week 12 and week 24 follow-ups)
研究者
Arna Hauksdottir
Professor
University of Iceland