Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) |
A 7 item self-report instrument designed to assess the frequency of disruptive nocturnal behaviors (e.g. acting out dreams, episodes of terror or screaming) common in PTSD. Participants are asked to report symptoms over the past month on a four-point Likert scale, ranging between 0 (never in the past month) and 3 (three or more times each week). The total score ranges from 0 to 21. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| Other |
Self-rated health rating (SRHR) |
A single item measuring perceived health status on a seven-point scale (from very good to very bad). Higher scores indicate better health. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| Other |
Sleep Condition Indicator (SCI-02) |
Two self-rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5-point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (0 - 4) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| Other |
Sick leave |
Two bespoke items measuring the total number and the number of full work days of sick leave the participant has taken over the past 4 weeks. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| Other |
The Time Perspective Questionnaire (TPQ) |
8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| Other |
The Future Self Questionnaire - shortened version (FSQ) |
A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity. |
3-month follow-up |
|
| Other |
Self-guided intervention adherence - usage of the gameplay intervention in daily life |
Two self-report items: "How many times did you manage to play Tetris after you experienced an intrusive memory?" (12-point scale: 0-10 or more than 10). If 1 or more is selected, participant is also asked: "Which of your intrusive memories did you target when you played on your own?" (open-ended question) |
Week 1, 1-month and 3-month follow-ups |
|
| Other |
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 (Week -1), Weeks 0-5, 3-month follow-up |
|
| Other |
Feasibility and acceptability - ratings |
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. |
1-month follow-up |
|
| Other |
Feasibility and acceptability - open-ended questions |
Feasibility and acceptability of the intervention assessed with 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?" |
1-month follow-up |
|
| Other |
Credibility/expectancy scale |
Prior to completing the intervention, participants provide 5 ratings of treatment expectancy as well as the degree to which they found the rationale for treatment credible; wording adapted to fit the current study. |
Week 0 |
|
| Primary |
Change in the total number of intrusive memories of trauma |
Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the fifth week after the second intervention session (Week 5), compared to in the baseline week (Week -1). |
Week 5 compared to Baseline (Week -1) |
|
| Secondary |
Change in the total number of intrusive memories of trauma |
Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the week of receiving the first two intervention sessions (Week 0), the subsequent four weeks (Weeks 1-4) and a 3-month follow-up, compared to in the baseline week (Week -1). |
Weeks 0-4 and 3-month follow-up compared to Baseline (Week -1) |
|
| Secondary |
Unwanted Memories of Trauma (UMT) |
6 self-rated items measuring the frequency of unwanted memories of the trauma in the previous week on a 7-point scale (from never to many times a day) and the level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the unwanted memories of the trauma on a 11-point scale (from 0 to 100). High scores indicate more unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and more different triggers. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| 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), Week 1, 1-month and 3-month follow-ups |
|
| 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 is scored from 0 (i.e., not at all) to 3 (i.e., nearly every day). |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| 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 is scored from 0 (i.e., not at all) to 3 (i.e., nearly every day). |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| 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), Week 1, 1-month and 3-month follow-ups |
|
| Secondary |
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
The WHODAS 2.0 is a 12-item self-rated questionnaire measuring difficulties due to health conditions, including mental or emotional problems (with reference to study event). Scores range from 1 ("none") to 5 ("extremely/cannot do"). The maximum score of the WHODAS is 60; lower scores indicate better functioning. |
Baseline (Week -1), Week 1, 1-month and 3-month follow-ups |
|
| 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), Week 1, 1-month and 3-month follow-ups |
|
| Secondary |
Rating of how long intrusive memories disrupted concentration on average |
One 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), Week 1, 1-month and 3-month follow-ups |
|
| 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), Week 1, 1-month and 3-month follow-ups |
|
| 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). Administered as part of the intrusive memory diary. |
Baseline (Week -1), Weeks 0-5, 3-month follow-up |
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