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

NCT ID: NCT05089058

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-11-04

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).

Conditions

Intrusive Memories of Traumatic Event(s)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief cognitive task (delivered digitally)

Group Type: EXPERIMENTAL

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

Intervention Type: 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 relaxation exercise task (delivered digitally)

Group Type: PLACEBO_COMPARATOR

Brief, digitally delivered relaxation task intervention, comprised of:

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: lead

Responsible Party

Andri Steinþór Björnsson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andri Björnsson

Role: PRINCIPAL_INVESTIGATOR

University of Iceland

Emily Holmes

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

University of Iceland, Sæmundargata 12

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

20-214

Identifier Type: -

Identifier Source: org_study_id