- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04342416
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Přehled studie
Detailní popis
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Reykjavík, Island, 101
- University of Iceland
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in the number of intrusive memories of trauma
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.)
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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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