The Lóa Study: A Brief Digital Intervention for Women With Intrusive Memories in the SAGA Cohort

May 3, 2026 updated by: Arna Hauksdottir, University of Iceland

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavik, Iceland, 102
        • University of Iceland, Sæmundargata 12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief imagery-competing task
Access to a brief imagery-competing task for 24 weeks (with optional researcher support during the study)
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.
Experimental: 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)
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.
Other: Treatment as usual (TAU)
Routine care that participants would otherwise receive if having intrusive memories of traumatic events

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intrusive memories of traumatic event(s)
Time Frame: 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.
Week 5 (all arms) controlling for run-in/baseline week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intrusive memories of the traumatic event(s)
Time Frame: Week 12 and week 24 follow-ups (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.
Week 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A 20-item questionnaire assessing the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"). Scores are summed to give a total severity score (ranging 0 to 80).
Baseline, week 5, week 12 and week 24 follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A 7-item questionnaire assessing the frequency of disruptive nocturnal behaviours (e.g., acting out dreams, episodes of terror or screaming). Respondents report symptoms over the past month on a 4-point Likert scale, ranging from 0 ("never in the past month") to 3 ("three or more times each week"). Total score ranges from 0 to 21 with higher scores indicating worse symptoms.
Baseline, week 5, week 12 and week 24 follow-ups
Cognitive Functions Scale
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
An 11 item questionnaire about cognitive functions in particular memory and concentration. Items are rated on a 5-point scale, from 1 ("every day") to 5 ("never"). Total scores range from 11 to 55; higher scores indicate less concentration and memory difficulties.
Baseline, week 5, week 12 and week 24 follow-ups

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A 9-item questionnaire assessing depression symptoms and their severity. Items are scored from 0 ( "not at all") to 3 ( "nearly every day"). The total score is the sum of all items and ranges from 0 to 27.
Baseline, week 5, week 12 and week 24 follow-ups
The Generalized Anxiety Disorder-7 scale (GAD-7)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A 7-item questionnaire assessing severity of anxiety symptoms. Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). The total score is the sum of all items and ranges from 0 to 21.
Baseline, week 5, week 12 and week 24 follow-ups
The Sheehan Disability Scale (SDS)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A questionnaire assessing functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. Domains are measured on an 11-point Likert scale, ranging from 0 ("not at all") to 10 ("extremely"). The scale is adapted to assess functional impairment associated with intrusive memories. The total score is the sum of all items and ranges from 0 to 30.
Baseline, week 5, week 12 and week 24 follow-ups
Quality of Life Scale (QOLS)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
16-item measure to assess quality of life on a 7-point Likert scale, ranging from 7 ("delighted") to 1 ("terrible"). The domains that are assessed are the following: (1) Social and community activities, (2) material and physical wellbeing, (3) relationships with other people, (4) personal development and fulfilment, and (5) recreation. The total score is the sum of all items and ranges from 16 to 112.
Baseline, week 5, week 12 and week 24 follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
A 12-item questionnaire assessing difficulties due to health conditions, including mental or emotional problems (with reference to intrusive memories). Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 ("none") to 4 ("extreme or cannot do"). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points). Lower scores indicate better functioning.
Baseline, week 5, week 12 and week 24 follow-ups
General Impact of intrusive memories
Time Frame: Baseline, week 5, week 12 and week 24 follow-ups
2-items measuring the general impact of intrusive memories in terms of level of distress and vividness associated with the intrusions on a 11-point scale (ranging from 0 to 10), rated at the end of each diary week. High scores indicate higher levels of distress/vividness.
Baseline, week 5, week 12 and week 24 follow-ups
Acceptability and feasibility
Time Frame: Week 5
Four questions to assess acceptability and feasibility of the both interventions. Rated on a 11-point scale (0 to 10) to measure the extent to which the individual would recommend the intervention and whether they consider it to be an acceptable way to reduce the frequency of intrusive memories. In addition, in this study, we include 1 item on the type of digital device used and 2 open-ended questions about the experience of using the digital platform.
Week 5
Adverse events (AEs)
Time Frame: Week 5, week 12 and week 24 follow-ups
A free-text response field measuring the occurrence of any health problems since the last contact.
Week 5, week 12 and week 24 follow-ups
Feedback Questionnaire
Time Frame: Week 5
A 7-item questionnaire will assess participants' experience of using the intervention. The first five items assess how easy, helpful, distressing, burdensome and interesting participants found the intervention. This was assessed on a 11-point scale ranging from 0 ("not at all") to 10 ("very"). The last 2 free-text items ask how the brief cognitive task could be improved, and for any other comments.
Week 5
Credibility/Expectancy Questionnaire
Time Frame: Right after randomization
6-item questionnaire that rates to what degree the participant finds the intervention credible on a 11-point scale from 0 to 10. High scores indicate greater credibility.
Right after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iceland

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Arna Hauksdóttir, PhD, University of Iceland
  • Principal Investigator: Emily Holmes, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Actual)

April 15, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised research data will be made available on Open Science Framework (OSF) indefinitely

IPD Sharing Time Frame

The aim is to share the Study Protocol and Statistical Analysis Plan upon the last participant completing the last visit. Supporting information mentioned above will be shared indefinitely and with no end date on the Open Science Framework (OSF) platform. The results of the study will be shared through open-access publications.

IPD Sharing Access Criteria

Anonymised research data will be made available on Open Science Framework (OSF) indefinitely.

OSF is an open-source web application that is freely accessible to the public and scientific community

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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