Clinical trial NCT05849337: The Lóa Study: a Brief Digital Intervention for Women with Intrusive Memories in the SAGA Cohort
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrusive Memories of Traumatic Event(s)
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2023-05-08
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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
* 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.

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 5 (all arms) controlling for run-in/baseline week
Secondary outcomes:
measure: Number of intrusive memories of the traumatic event(s)
timeFrame: Week 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: Cognitive Functions Scale
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
Other outcomes:
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: The Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: The Sheehan Disability Scale (SDS)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: Quality of Life Scale (QOLS)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: General Impact of intrusive memories
timeFrame: Baseline, week 5, week 12 and week 24 follow-ups
measure: Acceptability and feasibility
timeFrame: Week 5
measure: Adverse events (AEs)
timeFrame: Week 5, week 12 and week 24 follow-ups
measure: Credibility/Expectancy Questionnaire
timeFrame: Right after randomization
measure: Feedback Questionnaire
timeFrame: Week 5
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland, Sæmundargata 12
Study officials:
affiliation: University of Iceland
name: Arna Hauksdóttir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Emily Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.