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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
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.
Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.
Routine care that participants would otherwise receive if having intrusive memories of traumatic events
University of Iceland, Sæmundargata 12
Reykjavik, Iceland
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.
Time frame: Week 5 (all arms) controlling for run-in/baseline week
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
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