Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in the number of intrusive memories of trauma |
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 |
|
| Secondary |
Self-guided intervention adherence - usage of the gameplay intervention in daily life |
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 |
|
| Secondary |
Feasibility and acceptability ratings for using a smartphone game-play intervention |
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 |
|
| Secondary |
Feasibility and acceptability - open ended questions |
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 |
|
| Secondary |
Impact of intrusive memories on concentration, sleep and stress - ratings |
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 |
|
| Secondary |
Rating of how long intrusive memories disrupted concentration on average |
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 |
|
| Secondary |
General impact of intrusive memories - ratings |
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 |
|
| Secondary |
Intrusion diary adherence |
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 |
|
| Secondary |
The Posttraumatic Stress Disorder Checklist 5 (PCL-5) |
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 |
|
| Secondary |
The Patient Health Questionnaire-9 (PHQ-9) |
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 |
|
| Secondary |
The Generalized Anxiety Disorder-7 scale (GAD-7) |
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 |
|
| Secondary |
The Sheehan Disability Scale (SDS) |
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 |
|
| Secondary |
Impact of intrusive memories on functioning |
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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