Clinical trial NCT05089058: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Traumatic Event(s)
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2021-10-22
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
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, 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).

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

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 5
Secondary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Baseline, Week 1, Week 12 and Week 24
measure: The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: Characteristics of intrusive memories
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: Impact of intrusive memories on concentration, sleep and stress
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: General impact of intrusive memories
timeFrame: Baseline, Week 1, Week, 5, Week 12 and Week 24
measure: Impact of intrusive memories on daily functioning
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The Sheehan Disability Scale (SDS)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The Psychological Outcome Profiles; PSYCHLOPS
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: Self-rated Health rating (SRHR)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: Sleep Condition Indicator (SCI-2)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
measure: Time Perspective Questionnaire (TPQ)
timeFrame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Other outcomes:
measure: Credibility/expectancy scale.
timeFrame: First intervention session = 7 days from baseline, Week 1 and Week 5
measure: Vividness of visual imagery question (adapted from VVIQ-2)
timeFrame: First intervention session = 7 days from baseline
measure: Acceptability and feasibility
timeFrame: Week 1, 1-month, and 3-month follow-ups
measure: Intrusion diary adherence
timeFrame: Week 1, Week 5, Week 12 and Week 24
measure: Adverse Events (AEs).
timeFrame: Week 1, and 1-month, 3-month and 6-month follow-ups
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland, Sæmundargata 12
Study officials:
affiliation: University of Iceland
name: Andri Björnsson
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Emily Holmes
role: PRINCIPAL_INVESTIGATOR
References: