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

30 septembre 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Islande
      • Reykjavík, Islande, 101
        • University of Iceland

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

16 ans à 67 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Comportemental: Visiospatial 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in the number of intrusive memories of trauma
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Iceland

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 septembre 2020

Achèvement primaire (Réel)

1 septembre 2021

Achèvement de l'étude (Réel)

1 septembre 2021

Dates d'inscription aux études

Première soumission

8 avril 2020

Première soumission répondant aux critères de contrôle qualité

10 avril 2020

Première publication (Réel)

13 avril 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2021

Dernière vérification

1 septembre 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VIRMT

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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