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

30 september 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • IJsland
      • Reykjavík, IJsland, 101
        • University of Iceland

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 67 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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)).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the number of intrusive memories of trauma
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Iceland

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 september 2020

Primaire voltooiing (Werkelijk)

1 september 2021

Studie voltooiing (Werkelijk)

1 september 2021

Studieregistratiedata

Eerst ingediend

8 april 2020

Eerst ingediend dat voldeed aan de QC-criteria

10 april 2020

Eerst geplaatst (Werkelijk)

13 april 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

30 september 2021

Laatst geverifieerd

1 september 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VIRMT

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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