Lóa Project: An Exploratory Pilot Randomised Controlled Trial of a Remotely-delivered Brief Cognitive Intervention to Reduce Intrusive Memories of Trauma for Women in Iceland

Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. Previous research has demonstrated 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) with women in Iceland indicates that the intervention is acceptable and feasible.

This exploratory pilot trial will compare remote delivery of the intervention (i.e. brief, digitally delivered imagery-competing task intervention, n = 12) to an attention-placebo control condition (i.e., brief, digitally delivered relaxation exercise task; n = 12). We will explore whether (relative to the control condition) the intervention: (i) reduces the number of intrusive memories (primary outcome), and (ii) improves other symptoms and functioning.

This study is funded by the OAK foundation (OCAY-18-442) and the Strategic Research and Development Program: Societal Challenges in Iceland (200095-5601).

Study Overview

• Status: Completed
• Conditions: Intrusive Memories of Traumatic Event(s)
• Intervention / Treatment: Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of:; Behavioral: Brief, digitally delivered relaxation task intervention, comprised of:

Detailed Description

The proposed study will involve a brief intervention (c. 2 guided sessions with the researcher; options for up to 6 additional booster sessions) delivered digitally and remotely (i.e., not physically in-person), and with initial guided support (remotely delivered) from a researcher. Participants will be asked to fill out a diary indicating the number of intrusive memories they experienced, along with self-report questionnaires, at baseline (i.e., one week prior to commencement of the intervention), week 1 (week after the second intervention/control session), week 5 (primary outcome; 5 weeks from the second intervention/control session), and at 1-, 3- and 6-months follow-up.

Monitoring will be performed by a clinical trial unit to verify that the study is conducted and data are generated and documented in compliance with GCP and the applicable regulatory requirements.

Potentially eligible participants for this pilot study will be identified using data collected in the SAGA cohort study (an epidemiological study of trauma among Icelandic women).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík, Iceland, 102
    • University of Iceland, Sæmundargata 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Aged: 18-69 (at time of enrollment to cohort study)
• Able to speak and read study materials in Icelandic or English
• Willing to be contacted remotely and having access to a smartphone or computer
• Experienced intrusive memories in past month (PCL-5 item 1 score is ≥ 2)
• Experienced 2 or more intrusive memories of a traumatic event in the past week
• Willing to monitor intrusive memories in everyday life
• Willing and able to complete remote study sessions

Exclusion Criteria:

• Suicide risk indicated in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9) and by responses on MINI during follow-up telephone risk assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brief cognitive task (delivered digitally)	Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of: Two sessions guided (remotely) by a researcher. Sessions comprised of: (i) task procedure: a memory cue followed by playing imagery-competing computer game task with mental rotation instructions. Monitoring of intrusive memories to select hotspot cue, and which intrusion to target. (ii) accompanying information, including rationale for the brief cognitive task. (iii) option to use the brief cognitive task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher.
PLACEBO_COMPARATOR: Brief relaxation exercise task (delivered digitally)	Behavioral: Brief, digitally delivered relaxation task intervention, comprised of: Brief, digitally delivered relaxation task intervention, comprised of: Two sessions guided (remotely) by a researcher. Sessions comprised of: (i) relaxation exercise task using instruction components from progressive muscle relaxation (ii) accompanying information, including rationale for the brief relaxation exercise task. (iii) option to use the brief relaxation exercise task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories of traumatic event(s)	Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days	Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories of traumatic event(s)	Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days	Baseline, Week 1, Week 12 and Week 24
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)	A 20-item questionnaire assessing the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Symptoms are rated on a 5-point Likert-scale.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Patient Health Questionnaire-9 (PHQ-9)	A 9-item questionnaire assessing depression symptoms and their severity. Items are scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Generalized Anxiety Disorder-7 scale (GAD-7)	A 7-item questionnaire designed as a screening tool for symptoms of GAD and their severity. Items are scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Characteristics of intrusive memories	6 self-rated items assessing the frequency of unwanted memories of the trauma in the previous week (on a 7-point scale, from never to many times a day) and the level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with unwanted trauma memories (on an 11-point scale, from 0 to 100). Higher scores indicate more unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and more different triggers.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Impact of intrusive memories on concentration, sleep and stress	Assessed with six self-rated items anchored to the past week: two items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties), one item assessing duration of disruption after experiencing intrusive memory (<1 minute to > 60 minutes), two items assessing sleep disturbance due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance) and one item assessing the degree to which intrusive memories affected stress levels (0 = not at all; 10 = very much).	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
General impact of intrusive memories	Assessed with two self-rated items, one assessing the degree of distress associated with intrusive memories and the other assessing how vivid they were in the past week (both rated on an 11-point scale, 0 = not at all; 10 = very distressing; 0 = not at all; 10 = very vivid).	Baseline, Week 1, Week, 5, Week 12 and Week 24
Impact of intrusive memories on daily functioning	Assessed with four items. One question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" on an 11-point scale; higher score indicating greater impact on functioning. The other question is open-ended: "How have the intrusive memories affected your ability to function in your daily life in the past week?"). We will also explore whether there is a link between the content of participants' intrusive memories and specific domains of functioning - in open-ended discussion and using questions (asked at baseline) such as: "Are there any specific activities that you would like to do, but avoid because they are linked to your intrusive memories?" and "What change in your intrusive memories would make a meaningful difference in your life?" along with (asked at follow-ups, after the intervention/control task) "Since starting the study, are there any specific activities that you used to avoid (due to your intrusive memories), but now do more often?"	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Sheehan Disability Scale (SDS)	A self-report 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 (i.e., not at all) to 10 (i.e., extremely). The scale will be adapted to assess functional impairment associated with intrusive memories.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	A 12-item questionnaire assessing difficulties due to health conditions, including mental or emotional problems (with reference to study event). Scores range from 1 ("none") to 5 ("extremely/cannot do"). Lower scores indicate better functioning.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Psychological Outcome Profiles; PSYCHLOPS	A 4-item a patient-generated outcome measure of symptom-change after therapy/interventions, consisting of four items measuring three domains: problems (two items), function (one item), and well-being (one item). The patient chooses which symptoms or problems are most important to measure over the course of an intervention.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Self-rated Health rating (SRHR)	A single item assessing perceived health status on a 4-point scale (very good to very bad). The scale is reverse-scored; higher scores indicate better health.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)	A 7-item self-report questionnaire assessing the frequency of disruptive nocturnal behaviours (e.g., acting out dreams, episodes of terror or screaming) common in PTSD. 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. A clinical score ≥ 4 will be used, which discriminates between participants with and without PTSD.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Sleep Condition Indicator (SCI-2)	2 self-rated items; one assesses the extent to which the respondent is experiencing poor sleep (with reference to study event) on a 5-point scale (from not at all to very much), one assesses the number of nights in the week the respondent experiences sleep problems on 5-point scale (from 0-1 to 5-7 nights). Both 5-point scales are reverse scored (0 - 4) then summed. Possible total scores range from 0-8; higher values indicate better sleep.	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Time Perspective Questionnaire (TPQ)	8-items drawn or modified from both the Temporal Orientation Scale and the Zimbardo Time Perspective Inventory. Respondents rate how true statements are for them on a 5-point scale, from not at all true (1) to very true (5) (e.g., "My plans about the future are pretty well laid out", "It is best to live day-to-day").	Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility/expectancy scale.	Prior to completing the intervention, participants provide 4 ratings of treatment expectancy and the degree to which they found the intervention credible in both conditions.	First intervention session = 7 days from baseline, Week 1 and Week 5
Vividness of visual imagery question (adapted from VVIQ-2)	A self-rated item assessing the degree of vividness/clarity of a trauma memory after it is brought to mind during the first part of the intervention. Responses are scored on a 5-point scale from 1=no image at all to 5=perfectly clear and vivid as normal vision). In intervention arm only.	First intervention session = 7 days from baseline
Acceptability and feasibility	Self-rated questions assessing acceptability and feasibility of the intervention/control tasks (e.g., ratings of the extent to which the respondent would recommend the intervention, whether they consider it to be an acceptable way to reduce the frequency of intrusive memories). We will also include two self-rated and one open-ended question about the experience of using the digital platform to complete study procedures.	Week 1, 1-month, and 3-month follow-ups
Intrusion diary adherence	A self-rated item assessing self-reported accuracy of filling out the diary (0 = not at all; 10 = very accurately).	Week 1, Week 5, Week 12 and Week 24
Adverse Events (AEs).	Participants will be asked whether they had experienced any adverse events with one open-ended question: 'Have you had any health problems since the last contact?'	Week 1, and 1-month, 3-month and 6-month follow-ups

Collaborators and Investigators

• Sponsor: University of Iceland
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Andri Björnsson, University of Iceland

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): June 23, 2022
• Study Completion (ACTUAL): November 4, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Sharing Access Criteria

Anonymised research data will be made available on Open Science Framework (OSF) indefinitely.

OSF is an open source web application that is freely accessible to public and scientific community.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No