University of Iceland, Sæmundargata 12
Reykjavik, 102, Iceland
NCT Number: NCT05849337
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–73 year
Female
Interventional
Not applicable
Reykjavik, 102, Iceland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
A 9-item questionnaire assessing depression symptoms and their severity. Items are scored from 0 ( "not at all") to 3 ( "nearly every day"). The total score is the sum of all items and ranges from 0 to 27.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
A 7-item questionnaire assessing severity of anxiety symptoms. Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). The total score is the sum of all items and ranges from 0 to 21.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
A questionnaire assessing functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. Domains are measured on an 11-point Likert scale, ranging from 0 ("not at all") to 10 ("extremely"). The scale is adapted to assess functional impairment associated with intrusive memories. The total score is the sum of all items and ranges from 0 to 30.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
16-item measure to assess quality of life on a 7-point Likert scale, ranging from 7 ("delighted") to 1 ("terrible"). The domains that are assessed are the following: (1) Social and community activities, (2) material and physical wellbeing, (3) relationships with other people, (4) personal development and fulfilment, and (5) recreation. The total score is the sum of all items and ranges from 16 to 112.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
A 12-item questionnaire assessing difficulties due to health conditions, including mental or emotional problems (with reference to intrusive memories). Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 ("none") to 4 ("extreme or cannot do"). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points). Lower scores indicate better functioning.
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
2-items measuring the general impact of intrusive memories in terms of level of distress and vividness associated with the intrusions on a 11-point scale (ranging from 0 to 10), rated at the end of each diary week. High scores indicate higher levels of distress/vividness.
Time frame: Week 5
Four questions to assess acceptability and feasibility of the both interventions. Rated on a 11-point scale (0 to 10) to measure the extent to which the individual would recommend the intervention and whether they consider it to be an acceptable way to reduce the frequency of intrusive memories. In addition, in this study, we include 1 item on the type of digital device used and 2 open-ended questions about the experience of using the digital platform.
Time frame: Week 5, week 12 and week 24 follow-ups
A free-text response field measuring the occurrence of any health problems since the last contact.
Time frame: Right after randomization
6-item questionnaire that rates to what degree the participant finds the intervention credible on a 11-point scale from 0 to 10. High scores indicate greater credibility.
Time frame: Week 5
A 7-item questionnaire will assess participants' experience of using the intervention. The first five items assess how easy, helpful, distressing, burdensome and interesting participants found the intervention. This was assessed on a 11-point scale ranging from 0 ("not at all") to 10 ("very"). The last 2 free-text items ask how the brief cognitive task could be improved, and for any other comments.
University of Iceland
Other
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
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