The Lóa Study: A Brief Digital Intervention for Women With Intrusive Memories in the SAGA Cohort
NCT05849337 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380
Last updated 2026-05-07
Summary
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).
Conditions
- Intrusive Memories of Traumatic Event(s)
Interventions
- BEHAVIORAL
-
Brief imagery-competing task
Two digital self-guided sessions of a brief digital imagery-competing task. A memory cue followed by playing a computer game with mental rotation instructions.
- BEHAVIORAL
-
Brief psychoeducation and signposting task
Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.
- OTHER
-
Treatment as usual (TAU)
Routine care that participants would otherwise receive if having intrusive memories of traumatic events
Sponsors & Collaborators
-
Uppsala University
collaborator OTHER -
University of Iceland
lead OTHER
Principal Investigators
-
Arna Hauksdóttir, PhD · University of Iceland
-
Emily Holmes, PhD · Uppsala University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 73 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-30
- Primary Completion
- 2026-04-15
- Completion
- 2026-09-30
Countries
- Iceland
Study Locations
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