Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
30 de setembro de 2021 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
10
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Reykjavík, Islândia, 101
- University of Iceland
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
16 anos a 67 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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)).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the number of intrusive memories of trauma
Prazo: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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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.
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Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Prazo: Intervention week 2-6
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How often did you manage to play Tetris after you experienced an intrusive memory?
(11-point scale; 0 = not at all; 10 = every time).
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Intervention week 2-6
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Feasibility and acceptability ratings for using a smartphone game-play intervention
Prazo: 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.
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Post intervention up to week 7
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Feasibility and acceptability - open ended questions
Prazo: Post intervention up to week 7
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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?"
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Post intervention up to week 7
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Impact of intrusive memories on concentration, sleep and stress - ratings
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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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).
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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Rating of how long intrusive memories disrupted concentration on average
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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General impact of intrusive memories - ratings
Prazo: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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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)
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Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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Intrusion diary adherence
Prazo: Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
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Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
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The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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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.
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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The Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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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).
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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The Generalized Anxiety Disorder-7 scale (GAD-7)
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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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).
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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The Sheehan Disability Scale (SDS)
Prazo: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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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.
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Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
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Impact of intrusive memories on functioning
Prazo: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
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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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de setembro de 2020
Conclusão Primária (Real)
1 de setembro de 2021
Conclusão do estudo (Real)
1 de setembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
8 de abril de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de abril de 2020
Primeira postagem (Real)
13 de abril de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VIRMT
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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