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

NCT05089058 | Completed

• 1 other identifier: 20-214
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Intrusive Memories of Traumatic Event(s)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Number of intrusive memories of traumatic event(s)

  Baseline, Week 1, Week 12 and Week 24

• The Posttraumatic Stress Disorder Checklist 5 (PCL-5)

  Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups

• The Generalized Anxiety Disorder-7 scale (GAD-7)

  Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups

• Characteristics of intrusive memories

  Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups

Other Outcomes (5)

• Credibility/expectancy scale.

  First intervention session = 7 days from baseline, Week 1 and Week 5

• Vividness of visual imagery question (adapted from VVIQ-2)

  First intervention session = 7 days from baseline

• Acceptability and feasibility

  Week 1, 1-month, and 3-month follow-ups

Study Arms (2)

Brief cognitive task (delivered digitally)

EXPERIMENTAL

Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of:

Brief relaxation exercise task (delivered digitally)

PLACEBO COMPARATOR

Behavioral: Brief, digitally delivered relaxation task intervention, comprised of:

Interventions

Brief, digitally delivered imagery-competing task intervention package, comprised of: BEHAVIORAL

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.

Brief cognitive task (delivered digitally)

Brief, digitally delivered relaxation task intervention, comprised of: BEHAVIORAL

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.

Brief relaxation exercise task (delivered digitally)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iceland: lead
• Uppsala University: collaborator

Study Sites (1)

University of Iceland, Sæmundargata 12

Reykjavik, 102, Iceland

Location

Study Officials

• Andri Björnsson

  University of Iceland

  PRINCIPAL INVESTIGATOR

• Emily Holmes

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: June 23, 2022
• Study Completion: November 4, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

IC (1)