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

University of Iceland

Status

Completed

Conditions

Intrusive Memories of Traumatic Event(s)

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05089058

20-214

Details and patient eligibility

About

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).

Full 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).

Enrollment

13 patients

Sex

Female

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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