Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Reykjavík、アイスランド、101
- University of Iceland
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the number of intrusive memories of trauma
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-guided intervention adherence - usage of the gameplay intervention in daily life
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Andri Björnsson, PhD、University of Iceland Sæmundargata 12 101 Reykjavík, Iceland
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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