Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Reykjavík, Islandia, 101
- University of Iceland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the number of intrusive memories of trauma
Periodo de tiempo: Baseline week 1; Intervention week 1-6 and 1 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.
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Baseline week 1; Intervention week 1-6 and 1 month follow-up
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Change in the number of intrusive memories of trauma from baseline to 3 month follow up
Periodo de tiempo: Baseline week 1; 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) 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-guided intervention adherence - usage of the gameplay intervention in daily life
Periodo de tiempo: 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
Periodo de tiempo: Post intervention up to week 7
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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
Periodo de tiempo: 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
Periodo de tiempo: 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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General impact of intrusive memories - ratings
Periodo de tiempo: 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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Rating of how long intrusive memories disrupted concentration on average
Periodo de tiempo: 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 (<1 minute - > 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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Intrusion diary adherence
Periodo de tiempo: Baseline phase week 1; Intervention week 1-6 and 1 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 and 1 month follow-up
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The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Periodo de tiempo: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
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The Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
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The Generalized Anxiety Disorder-7 scale (GAD-7)
Periodo de tiempo: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
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The Sheehan Disability Scale (SDS)
Periodo de tiempo: Baseline week 1; Post intervention up to week 7 and 1 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 and 1 month follow-up
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Impact of intrusive memories on functioning
Periodo de tiempo: 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: "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.)
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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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andri Björnsson, PhD, University of Iceland Sæmundargata 12 101 Reykjavík, Iceland
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UI-2019-VIRM
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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