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

Not Applicable

Recruiting

Interventions: Behavioral: Brief imagery-competing task
Other: Treatment as usual (TAU)
Behavioral: Brief psychoeducation and signposting task

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).

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.

Recruitment & Eligibility

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
Experienced intrusive memories in past month (PCL-item 1 score is 3 or above)
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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of intrusive memories of traumatic event(s)	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.

Secondary Outcome Measures

Name	Time	Method
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 number of intrusive memories of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days.
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)	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.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	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).
Cognitive Functions Scale	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.