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
Condition: Intrusive Memories of Traumatic Event(s)
Study type: Interventional

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).
    

Intervention name(s): Brief, digitally delivered imagery-competing task intervention package, comprised of:; Brief, digitally delivered relaxation task intervention, comprised of:
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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, 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment