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

Study Overview
=================
Brief Summary
-----------------
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).

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).

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

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:


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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 cognitive task (delivered digitally)<br> | Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of:<br>* 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.<br>|
| Placebo Comparator: Brief relaxation exercise task (delivered digitally)<br> | Behavioral: Brief, digitally delivered relaxation task intervention, comprised of:<br>* 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.<br>|

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 |