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Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

14 lutego 2022 zaktualizowane przez: Andri Steinþór Björnsson, University of Iceland
This research study 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, we will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Participants will attend 3-8 sessions with the researcher. 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, participants complete questionnaires and monitor the frequency of intrusive memories for one week in the daily diary.

The previous version of the CTR incorrectly stated that at the 3 month time point the measure of intrusions will be: 'Questions about the frequency of intrusive memories for the past day/week (for each intrusive memory, to be tallied to arrive at a mean frequency for the memories for the previous day and for the week)'. We changed this measure at the study start to using the same diary as we used for the earlier time points (i.e., daily diary with the same level of detail as the ones used at e.g. at 1 month), but failed to update this in the CTR. The measure has been updated retrospectively in the CTR for this timepoint, and should be interpreted with caution accordingly.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

5

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Islandia
      • Reykjavík, Islandia, 101
        • University of Iceland

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 69 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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)).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Behawioralne: Visuospatial interference
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the number of intrusive memories of trauma
Ramy czasowe: Baseline week 1; Intervention week 1-6 and 1 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.
Baseline week 1; Intervention week 1-6 and 1 month follow-up
Change in the number of intrusive memories of trauma from baseline to 3 month follow up
Ramy czasowe: Baseline week 1; 3 month follow-up

Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) per week during the baseline phase and during one week at three month follow-up.

Note that the way this outcome was measured had been specified incorrectly in the previous versions of this CTR (as using questions about frequency) and was therefore updated retrospectively after the end of data collection to the same diary as the previous time points.
Baseline week 1; 3 month follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
General impact of intrusive memories - ratings
Ramy czasowe: 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
Rating of how long intrusive memories disrupted concentration on average
Ramy czasowe: 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 (<1 minute - > 60 minutes)
Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Intrusion diary adherence
Ramy czasowe: Baseline phase week 1; Intervention week 1-6 and 1 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 and 1 month follow-up
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Ramy czasowe: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
The Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
The Generalized Anxiety Disorder-7 scale (GAD-7)
Ramy czasowe: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
The Sheehan Disability Scale (SDS)
Ramy czasowe: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
Impact of intrusive memories on functioning
Ramy czasowe: 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: "How have the intrusive memories affected your ability to function in your daily life in the past week?" 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Iceland

Śledczy

  • Główny śledczy: Andri Björnsson, PhD, University of Iceland Sæmundargata 12 101 Reykjavík, Iceland

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 stycznia 2020

Zakończenie podstawowe (Rzeczywisty)

20 sierpnia 2020

Ukończenie studiów (Rzeczywisty)

20 sierpnia 2020

Daty rejestracji na studia

Pierwszy przesłany

6 grudnia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 grudnia 2019

Pierwszy wysłany (Rzeczywisty)

24 grudnia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 marca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lutego 2022

Ostatnia weryfikacja

1 lutego 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UI-2019-VIRM

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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