Clinical trial NCT04709822: Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories of Trauma
Official title: Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Intrusive memories
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2021-01-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. The current study is an extension on two studies already preregistered (NCT04209283 and NCT04342416) that included some aspects of in-person recruitment and/or intervention delivery (rather than fully remote as we aim for here). The intervention is a simple cognitive task (a memory cue followed by playing the computer game "Tetris") with accompanying information. A within-subjects multiple baseline AB design is used, in that the length of baseline ('A'; no intervention) and intervention ('B') phases vary within-subjects across individual intrusive trauma memories. Participants will aim to complete at least one week of the baseline ('A') phase followed by at least two intervention sessions with a researcher remotely (via telephone or secure video platform). Intervention sessions comprise the simple cognitive task alongside accompanying information presented in the form of brief animated videos (e.g., explaining the target symptom). Participants are instructed that they may continue using the technique self-guided in subsequent weeks, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary. It is predicted that participants will report fewer total intrusive memories in the fifth week after the second intervention session (primary outcome) compared to in the first baseline week. The investigators will also explore whether the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, the investigators will explore whether having fewer intrusive memories is related to functioning and/or PTSD, depressive or anxiety symptoms.

Detailed description: Participants complete a total of 3-9 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect). In the baseline session, questionnaires are administered and the individual intrusive trauma memories will be logged for monitoring their frequency in a daily diary. Participants will record their intrusive memories in the daily diary for at least one week (Week -1) before commencing the intervention. In the first intervention session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation). We aim to deliver a second intervention session soon after the first (within approx. one week), targeting the same or a different intrusive memory. Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). Participants continue to monitor the frequency of both targeted and non-targeted intrusive memories in the daily diary throughout Weeks 0-5. Follow-up questionnaires are completed at Week 1, 1-month, and 3-months after the second intervention session. The primary outcome is change in total number of intrusive memories from the baseline week (Week -1) to the fifth week after the second intervention session (Week 5). Participants will also monitor the frequency of their intrusive memories for one week at the 3-month follow-up. The investigators note that the intended time-frames may differ slightly across participants depending on availability and the practicalities of remote delivery.

Eligibility criteria: Inclusion Criteria:

* Having experienced at least one criterion A trauma according to the DSM-5
* Having at least two intrusive memories over the previous week
* Reporting being bothered by intrusive memories over the past month (scoring at least a moderate or higher score on PCL-5 item 1)
* Being able and willing to complete 3-9 sessions with researcher
* Being willing to monitor intrusive memories in daily life
* Having access to a smartphone
* Being able to speak Icelandic and read study materials in Icelandic

Exclusion Criteria:

* Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI))
* Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI))
* Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI))

Primary outcomes:
measure: Change in the total number of intrusive memories of trauma
timeFrame: Week 5 compared to Baseline (Week -1)
Secondary outcomes:
measure: Change in the total number of intrusive memories of trauma
timeFrame: Weeks 0-4 and 3-month follow-up compared to Baseline (Week -1)
measure: Unwanted Memories of Trauma (UMT)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Sheehan Disability Scale (SDS)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Impact of intrusive memories on concentration, sleep and stress - ratings
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Rating of how long intrusive memories disrupted concentration on average
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Impact of intrusive memories on functioning
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: General impact of intrusive memories - ratings
timeFrame: Baseline (Week -1), Weeks 0-5, 3-month follow-up
Other outcomes:
measure: The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Self-rated health rating (SRHR)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Sleep Condition Indicator (SCI-02)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: Sick leave
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Time Perspective Questionnaire (TPQ)
timeFrame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
measure: The Future Self Questionnaire - shortened version (FSQ)
timeFrame: 3-month follow-up
measure: Self-guided intervention adherence - usage of the gameplay intervention in daily life
timeFrame: Week 1, 1-month and 3-month follow-ups
measure: Intrusion diary adherence
timeFrame: Baseline (Week -1), Weeks 0-5, 3-month follow-up
measure: Feasibility and acceptability - ratings
timeFrame: 1-month follow-up
measure: Feasibility and acceptability - open-ended questions
timeFrame: 1-month follow-up
measure: Credibility/expectancy scale
timeFrame: Week 0
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland
Study officials:
affiliation: University of Iceland
name: Andri Björnsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: