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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Intrusive Memories of Traumatic Event(s)

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief imagery-competing task<br>Access to a brief imagery-competing task for 24 weeks (with optional researcher support during the study) | Behavioral: Brief imagery-competing task<br>* 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.<br>|
| Experimental: Brief psychoeducation and signposting task<br>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<br>* Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.<br>|
| Other: Treatment as usual (TAU)<br>Routine care that participants would otherwise receive if having intrusive memories of traumatic events. | Other: Treatment as usual (TAU)<br>* Routine care that participants would otherwise receive if having intrusive memories of traumatic events<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusive memories of the 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 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week | 
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | 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) | 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 | 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 |