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

NCT05849337 | Active Not Recruiting DMC

• 1 other identifier: 22-186
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Number of intrusive memories of traumatic event(s)

  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 Outcomes (4)

• 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 Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  Baseline, week 5, week 12 and week 24 follow-ups

• The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)

  Baseline, week 5, week 12 and week 24 follow-ups

• Cognitive Functions Scale

  Baseline, week 5, week 12 and week 24 follow-ups

Other Outcomes (10)

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, week 5, week 12 and week 24 follow-ups

• The Generalized Anxiety Disorder-7 scale (GAD-7)

  Baseline, week 5, week 12 and week 24 follow-ups

• The Sheehan Disability Scale (SDS)

  Baseline, week 5, week 12 and week 24 follow-ups

Study Arms (3)

Brief imagery-competing task

EXPERIMENTAL

Access to a brief imagery-competing task for 24 weeks (with optional researcher support during the study)

Behavioral: Brief imagery-competing task

Brief psychoeducation and signposting task

EXPERIMENTAL

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

Treatment as usual (TAU)

OTHER

Routine care that participants would otherwise receive if having intrusive memories of traumatic events.

Other: Treatment as usual (TAU)

Interventions

Brief imagery-competing task BEHAVIORAL

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.

Brief imagery-competing task

Brief psychoeducation and signposting task BEHAVIORAL

Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.

Brief psychoeducation and signposting task

Treatment as usual (TAU) OTHER

Routine care that participants would otherwise receive if having intrusive memories of traumatic events

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iceland: lead
• Uppsala University: collaborator

Study Sites (1)

University of Iceland, Sæmundargata 12

Reykjavik, 102, Iceland

Location

Related Publications (3)

• Jonsdottir SD, Hauksdottir A, Aspelund T, Jakobsdottir J, Runarsdottir H, Gudmundsdottir B, Tomasson G, Valdimarsdottir UA, Halldorsdottir T, Thordardottir EB. Risk factors for workplace sexual harassment and violence among a national cohort of women in Iceland: a cross-sectional study. Lancet Public Health. 2022 Sep;7(9):e763-e774. doi: 10.1016/S2468-2667(22)00201-8.

  PMID: 36057275 BACKGROUND

• Yang Q, Thornorethardottir EB, Hauksdottir A, Aspelund T, Jakobsdottir J, Halldorsdottir T, Tomasson G, Runarsdottir H, Danielsdottir HB, Bertone-Johnson ER, Sjolander A, Fang F, Lu D, Valdimarsdottir UA. Association between adverse childhood experiences and premenstrual disorders: a cross-sectional analysis of 11,973 women. BMC Med. 2022 Feb 21;20(1):60. doi: 10.1186/s12916-022-02275-7.

  PMID: 35184745 BACKGROUND

• Danielsdottir HB, Aspelund T, Thordardottir EB, Fall K, Fang F, Tomasson G, Runarsdottir H, Yang Q, Choi KW, Kennedy B, Halldorsdottir T, Lu D, Song H, Jakobsdottir J, Hauksdottir A, Valdimarsdottir UA. Adverse childhood experiences and resilience among adult women: A population-based study. Elife. 2022 Feb 1;11:e71770. doi: 10.7554/eLife.71770.

  PMID: 35101173 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Arna Hauksdóttir, PhD

  University of Iceland

  PRINCIPAL INVESTIGATOR

• Emily Holmes, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: October 30, 2023
• Primary Completion: April 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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

Locations

IC (1)