Digital intervention for women with intrusive memories
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
This study tests whether a short online program can help women in the SAGA group reduce unwanted memories compared to usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years to 73 Years |
| Sex | Female |
| Sponsor | University of Iceland Academic / other |
| Locations | 1 site (Reykjavík) |
| Trial ID | NCT05849337 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a brief digital intervention aimed at reducing intrusive memories in women who are part of the SAGA cohort. Participants will be randomly assigned to one of three groups: a self-guided imagery-competing task, a self-guided psychoeducation task, or treatment as usual. The study will assess the number of intrusive memories experienced by participants over a five-week period, controlling for baseline memory frequency. The research will utilize both frequentist and Bayesian statistical analyses to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates are Icelandic women aged 18 and above who have experienced three or more intrusive memories in the past week and are part of the SAGA cohort.
Not a fit: Patients who do not experience at least three intrusive memories during the baseline week or are at risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the frequency of intrusive memories, improving daily functioning and emotional well-being for affected women.
How similar studies have performed: Previous pilot studies have shown that similar cognitive interventions can be effective in reducing intrusive memories, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Reykjavík
- University of Iceland, Sæmundargata 12 — Reykjavík, Iceland (Recruiting)
Study contacts
- Principal investigator: Arna Hauksdóttir, PhD — University of Iceland
- Study coordinator: Arna Hauksdóttir, PhD
- Email: arnah@hi.is
- Phone: +354-695-1072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.