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This is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.
Women who have experienced an early pregnancy loss (miscarriage or ectopic pregnancy) will be randomly allocated to either a brief cognitive intervention or a placebo activity. Participants will be followed up at week 1, 1 month and 3 months following the intervention. It is hypothesised that those allocated to receive the brief cognitive task-based intervention will develop fever intrusive memories, less severe mental health symptoms and better day to day functioning when compared to women allocated to the placebo activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A brief cognitive task-based based intervention | Experimental | Participants will engage in a brief cognitive task including: a memory reminder procedure, playing the computer game, Tetris, on a smart-device using mental rotation +/- Booster. |
|
| Placebo activity | Placebo Comparator | Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief cognitive task-based intervention | Behavioral | Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation +/- Boosters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of intrusive memories of early pregnancy loss | Number of intrusive memories during the first week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days. | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intrusive memories of early pregnancy loss | Number of intrusive memories during the fifth week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days. | Week 5 |
| Character of intrusive memories |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between number of intrusive memories of early pregnancy loss and 1. Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the number of intrusive memories of early pregnancy loss and 1. Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Bourne | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial college healthcare NHS trust | London | United Kingdom |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000022 | Abortion, Spontaneous |
| D011271 | Pregnancy, Ectopic |
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011248 | Pregnancy Complications |
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Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.
| Placebo activity | Behavioral | Listening to a pod-cast on a smart-device for approximately 15 minutes. |
|
Character of intrusive memories measured using a numeric scale out of 10 (minimum 1 maximum 10) to rate how vivid and how distressing the intrusive memories were during the first and fifth week following early pregnancy loss |
| Week 1 and week 5 |
| Severity of PTSD symptoms | Severity of PTSD measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) 1 and 3 months following early pregnancy loss. Score range is 0-80 with a higher score representing more severe symptoms. | 1 month and 3 months |
| Frequency and Severity of Functional Impairment | Functional impairment measured using the Work and Social Adjustment Scale (WSAS) measured 1 and 3 months following early pregnancy loss. Scores range from 0-40 with the higher score representing worse impairment. | 1 month and 3 months |
| Severity of re-experiencing symptoms cluster | Severity of re-experiencing symptoms cluster measured using the re-experincing symptom sub-scale of the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 and 3 month following early pregnancy loss. Minimum score 0 maximum score 20 with the higher score being worse. | 1 month and 3 months |
| Number of women meeting the diagnostic threshold for PTSD diagnosis | Number of women meeting the diagnostic threshold for PTSD diagnosis measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 month and 3 months following early pregnancy loss. | 1 month and 3 months |
| Severity of Anxiety symptoms | Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe | 1 month and 3 months |
| Severity of Depressions Symptoms | Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe. | 1 month and 3 months |
| Number of women meeting the diagnostic threshold for moderate/severe anxiety | Number of women meeting the diagnostic threshold for moderate/severe anxiety measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe | 1 month and 3 months |
| Number of women meeting the diagnostic threshold for moderate/severe depression | Number of women meeting the diagnostic threshold for moderate/severe depression measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe | 1 month and 3 months |
| Week 1 , week 5, 1 month and 3 months |
| The relationship between the severity of PTSD symptoms and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the severity of PTSD symptoms measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | 1 month and 3 months |
| The relationship between the number of women who reach PTSD diagnostic thresholds and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the number of women who reach PTSD diagnostic threshold at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | 1 and 3 months |
| The relationship between the severity of functional impairment measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the severity of functional impairment measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | 1 and 3 months |
| The relationship between the severity of symptoms of anxiety and depression, and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the severity of symptoms of anxiety and depression, and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | 1 and 3 months |
| The relationship between the number of women who meet anxiety or depression diagnostic thresholds and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | The relationship between the number of women who meet diagnostic thresholds for moderate/severe anxiety or depression and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy. | 1 and 3 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |