The Lóa Study: a Brief Digital Intervention for Women with Intrusive Memories in the SAGA Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2025-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Intrusive Memories of Traumatic Event(s)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brief imagery-competing task

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

Group Type EXPERIMENTAL

Brief imagery-competing task

Intervention Type 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 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)

Group Type EXPERIMENTAL

Brief psychoeducation and signposting task

Intervention Type BEHAVIORAL

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

Treatment as usual (TAU)

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

Group Type OTHER

Treatment as usual (TAU)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Brief psychoeducation and signposting task

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

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

73 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes