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

Intrusive Memories of Traumatic Event(s) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849337
• Other study ID #: 22-186
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: October 2023
• Source: University of Iceland
• Contact: Arna Hauksdóttir, PhD
• Phone: +354-695-1072
• Email: arnah[@]hi.is
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: March 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 73 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrusive Memories of Traumatic Event(s)

Intervention

Behavioral:
• Brief imagery-competing task
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.
• Brief psychoeducation and signposting task
Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.

Other:
• Treatment as usual (TAU)
Routine care that participants would otherwise receive if having intrusive memories of traumatic events

Locations

Country	Name	City	State
Iceland	University of Iceland, Sæmundargata 12	Reykjavík

Sponsors (2)

Lead Sponsor	Collaborator
University of Iceland	Uppsala University

Country where clinical trial is conducted

Iceland, 

References & Publications (3)

Danielsdottir HB, Aspelund T, Thordardottir EB, Fall K, Fang F, Tomasson G, Runarsdottir H, Yang Q, Choi KW, Kennedy B, Halldorsdottir T, Lu D, Song H, Jakobsdottir J, Hauksdottir A, Valdimarsdottir UA. Adverse childhood experiences and resilience among adult women: A population-based study. Elife. 2022 Feb 1;11:e71770. doi: 10.7554/eLife.71770. — View Citation

Jonsdottir SD, Hauksdottir A, Aspelund T, Jakobsdottir J, Runarsdottir H, Gudmundsdottir B, Tomasson G, Valdimarsdottir UA, Halldorsdottir T, Thordardottir EB. Risk factors for workplace sexual harassment and violence among a national cohort of women in Iceland: a cross-sectional study. Lancet Public Health. 2022 Sep;7(9):e763-e774. doi: 10.1016/S2468-2667(22)00201-8. — View Citation

Yang Q, Thornorethardottir EB, Hauksdottir A, Aspelund T, Jakobsdottir J, Halldorsdottir T, Tomasson G, Runarsdottir H, Danielsdottir HB, Bertone-Johnson ER, Sjolander A, Fang F, Lu D, Valdimarsdottir UA. Association between adverse childhood experiences and premenstrual disorders: a cross-sectional analysis of 11,973 women. BMC Med. 2022 Feb 21;20(1):60. doi: 10.1186/s12916-022-02275-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Patient Health Questionnaire-9 (PHQ-9)	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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	The Generalized Anxiety Disorder-7 scale (GAD-7)	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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	The Sheehan Disability Scale (SDS)	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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	Quality of Life Scale (QOLS)	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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	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 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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	General Impact of intrusive memories	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.	Baseline, week 5, week 12 and week 24 follow-ups
Other	Acceptability and feasibility	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.	Week 5
Other	Adverse events (AEs)	A free-text response field measuring the occurrence of any health problems since the last contact.	Week 5, week 12 and week 24 follow-ups
Other	Credibility/Expectancy Questionnaire	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.	Right after randomization
Other	Feedback Questionnaire	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.	Week 5
Primary	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	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
Secondary	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
Secondary	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
Secondary	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