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Difficulty in recruiting patients.
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The primary objective of this study is to examine the effects of cognitive bias modification for interpretation (CBM-I) on prenatal anxiety in parturients. Half of the participants will receive CBM-I assignments, while the other half will receive placebo assignments.
Maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. Recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as Cognitive Bias Modification for Interpretation (CBM-I), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. Our goal is to identify patients with prenatal anxiety and evaluate the effects of CBM-I on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBM-I assignment | Experimental | Patients will receive CBM-I assignments |
|
| Placebo assignment | Placebo Comparator | Patients will receive placebo assignments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Bias Modification for Interpretation (CBM-I) | Behavioral | Patients will receive CBM-I training by reading and imaging themselves in a series of emotionally ambiguous scenarios. Each scenario ends with an incomplete final word. Patients need to complete the final word to resolve the scenario in a positive direction. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety | Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment. | 4 weeks (starting from 36-week gestation) |
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Inclusion Criteria:
Exclusion Criteria:
Parturients only
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| Name | Affiliation | Role |
|---|---|---|
| Jie Zhou, MD, MS, MBA | Harvard Medical School (HMS and HSDM) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22023278 | Background | Lester KJ, Field AP, Muris P. Experimental modification of interpretation bias about animal fear in young children: effects on cognition, avoidance behavior, anxiety vulnerability, and physiological responding. J Clin Child Adolesc Psychol. 2011;40(6):864-77. doi: 10.1080/15374416.2011.618449. | |
| 22963595 | Result |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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|
| Placebo | Behavioral | Patients will receive placebo task which uses neutral rather than emotional material. |
|
| Bowler JO, Mackintosh B, Dunn BD, Mathews A, Dalgleish T, Hoppitt L. A comparison of cognitive bias modification for interpretation and computerized cognitive behavior therapy: effects on anxiety, depression, attentional control, and interpretive bias. J Consult Clin Psychol. 2012 Dec;80(6):1021-33. doi: 10.1037/a0029932. Epub 2012 Sep 10. |
| 16084841 | Result | O'Connor TG, Ben-Shlomo Y, Heron J, Golding J, Adams D, Glover V. Prenatal anxiety predicts individual differences in cortisol in pre-adolescent children. Biol Psychiatry. 2005 Aug 1;58(3):211-7. doi: 10.1016/j.biopsych.2005.03.032. |