Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
30 сентября 2021 г. обновлено: 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.
Обзор исследования
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
10
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Reykjavík, Исландия, 101
- University of Iceland
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 16 лет до 67 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
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)).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in the number of intrusive memories of trauma
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
8 сентября 2020 г.
Первичное завершение (Действительный)
1 сентября 2021 г.
Завершение исследования (Действительный)
1 сентября 2021 г.
Даты регистрации исследования
Первый отправленный
8 апреля 2020 г.
Впервые представлено, что соответствует критериям контроля качества
10 апреля 2020 г.
Первый опубликованный (Действительный)
13 апреля 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 октября 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
30 сентября 2021 г.
Последняя проверка
1 сентября 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- VIRMT
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .