Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
2021년 9월 30일 업데이트: Andri Steinþór Björnsson, University of Iceland
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
This research study is an extension on a study already preregistered NCT04209283 and is designed to investigate the use of a simple cognitive task (a memory cue followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland.
This is a single case series using a within subject multiple baseline AB design.
Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue using the technique self-guided in subsequent weeks.
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 intrusive memories during the intervention phase than during the preceding baseline phase and that 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 has an impact on function and/or PTSD, depressive or anxiety symptoms.
연구 개요
상세 설명
Participants will attend 3-8 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect).
In session one, the intrusive memories will be logged for monitoring their frequency in a daily diary for the following weeks.
Baseline assessment questionnaires will also administered.
In the second session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation) followed by monitoring the frequency of both the targeted and non-targeted intrusive memories.
Participants will also complete self-rated questions concerning the impact of their intrusive memories.
The intervention session will be repeated for other intrusive memories (maximum 6 intervention sessions).
In the last intervention session, participants will be asked to complete questionnaires and self-rated questions assessing the impact of their intrusive memories.
Participants will be asked to complete measures at 1 month follow-up and at 3 month follow-up.
In the 1 month follow-up and the 3 month follow-up, participants complete questionnaires and monitor the frequency of intrusive memories for one week.
The investigators note that the intended timeframes (e.g.
one-week for baseline and one-week for intervention phase) may differ slightly across participants depending on availability and the practicalities of remote delivery.
연구 유형
중재적
등록 (실제)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Reykjavík, 아이슬란드, 101
- University of Iceland
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
14년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Having experienced at least one criterion A trauma according to the DSM-5
- Having at least one intrusive memory that occurs at least three times per week in the past four weeks
- Being able to attend 3-8 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)).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Trauma exposed women
No Intervention: Baseline phase ('A'): Measurements collected in a daily diary four times a day (morning, afternoon, evening and night) over one week for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. Experimental: Intervention phase ('B'): A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game-play with mental rotation) followed by instructions to engage in the task self-guided over the subsequent week. Measurements collected in a daily diary four times a day following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Intervention: Behavioral: Brief cognitive intervention |
Behavioral: Brief cognitive intervention.
A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in the number of intrusive memories of trauma
기간: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and each week during the intervention phase (week 1-6) and during one week at one month follow-up and three month follow-up.
|
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-guided intervention adherence - usage of the gameplay intervention in daily life
기간: Intervention week 2-6
|
How often did you manage to play Tetris after you experienced an intrusive memory?
(11-point scale; 0 = not at all; 10 = every time).
|
Intervention week 2-6
|
|
Feasibility and acceptability ratings for using a smartphone game-play intervention
기간: Post intervention up to week 7
|
Feasibility and Acceptability of the intervention assessed with two self-rated items, "Would you recommend playing Tetris to a friend?" and "Do you consider gameplay to be an acceptable way to reduce the daily frequency of intrusive memories?".
Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility.
|
Post intervention up to week 7
|
|
Feasibility and acceptability - open ended questions
기간: Post intervention up to week 7
|
Two open-ended questions: 1. "How did you feel about playing Tetris after you had an intrusive memory?" 2. "Did you find the intervention helpful?
If yes, how?"
|
Post intervention up to week 7
|
|
Impact of intrusive memories on concentration, sleep and stress - ratings
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
Six self-rated items to assess the impact of intrusive memories on concentration, sleep, and stress in the past week.
2 items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties).
2 items assessing sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
Rating of how long intrusive memories disrupted concentration on average
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
General impact of intrusive memories - ratings
기간: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Two items both rated on an 11-point scale: 1. "During the last week, how distressing were your intrusive memories (0 = not at all; 10 = very distressing).
2. During the last week, how vivid were your intrusive memories (0 = not at all; 10= very vivid)
|
Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
|
Intrusion diary adherence
기간: Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
|
Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
|
|
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The PCL-5 is a short 20-item self-report scale used to assess the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD.
Symptoms are rated from 0-4.
Higher scores indicate greater severity.
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
The Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The PHQ-9 is a 9-item self-report measure of depression symptoms and the severity of those symptoms.
Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
The Generalized Anxiety Disorder-7 scale (GAD-7)
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The GAD-7 is a brief self-report questionnaire designed as a screening tool for symptoms of general anxiety disorder and their severity.
Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
The Sheehan Disability Scale (SDS)
기간: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
The SDS is a self-report questionnaire which is designed to assess functional impairment across three domains: (1) Work/school, (2) social, and (3) family life.
These domains are measured on an 11-point scale which ranges from 0 (i.e., not at all) to 10 (i.e., extremely).
The scale will be adjusted to assess impairment associated with intrusive memories.
|
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
|
|
Impact of intrusive memories on functioning
기간: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
|
Two questions assessing the impact intrusive memories have on functioning in daily life.
One question is open-ended: "Have the intrusive memories affected your ability to function in your daily life in the past week?
If yes, how?" and one question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" (11-point scale, higher score indicate greater impact on functioning.)
|
Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 9월 8일
기본 완료 (실제)
2021년 9월 1일
연구 완료 (실제)
2021년 9월 1일
연구 등록 날짜
최초 제출
2020년 4월 8일
QC 기준을 충족하는 최초 제출
2020년 4월 10일
처음 게시됨 (실제)
2020년 4월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 30일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .