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

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)

Interventions

BEHAVIORAL

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

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.

BEHAVIORAL

Brief, digitally delivered relaxation task intervention, comprised of:

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.

Sponsors & Collaborators

• Uppsala University

  collaborator OTHER

• University of Iceland

  lead OTHER

Principal Investigators

• Andri Björnsson · University of Iceland

• Emily Holmes · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2022-06-23

Completion

2022-11-04

Countries

• Iceland

Study Locations