Prevention of Postpartum Traumatic Stress (PTSD) in Mothers With Preterm Infants.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stanford University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01307293
First received: February 28, 2011
Last updated: May 10, 2011
Last verified: May 2011
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Purpose
The purpose of the study includes:
- To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU).
- To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention.
We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention offered to parents of NICU infants can prevent or minimize the development of symptoms of psychological distress in parents, including symptoms of anxiety and depression and posttraumatic stress disorder (PTSD).
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic |
Behavioral: Cognitive behavior therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants. |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Davidson Trauma Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- BDI-II [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- NCAST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cognitive Behavior Therapy
6-12 sessions of Cognitive Behavior Therapy to address PTSD symptoms and parenting issues related to premature infants.
|
Behavioral: Cognitive behavior therapy
6 or 12 sessions of cognitive behavior therapy.
|
|
No Intervention: Placebo comparison
Education regarding NICU parenting issues.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
English and Spanish-speaking mothers greater than 18 years of age of infants in the LPCH NICU >=26 weeks of gestation are eligible for screening.
Exclusion Criteria:
- Mothers of children awaiting cardiac surgery, those who have congenital abnormities and those who are unlikely to survive, will be excluded.
- Mothers of NICU infants who are found on their routine clinical psychosocial evaluation to be at high psychiatric risk (i.e., those with either psychotic symptoms or suicidal or infanticidal ideation) will also be excluded. These parents, however, will be referred for and receive appropriate mental health intervention.
- Mothers who do not speak English or Spanish, or who do not have the ability to understand the questionnaires will be excluded.
- Mothers who have active and current symptoms of suicidal ideation, or psychotic symptoms (delusions or hallucinations) as identified by self report or following a diagnostic interview will be excluded from the study, but will also be referred for emergency psychiatric evaluation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307293
Contacts
| Contact: Richard J Shaw, MD | (650) 723-5457 | rjshaw@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Richard J Shaw, MD 650-723-5457 rjshaw@stanford.edu | |
| Principal Investigator: Sarah McCue Horwitz | |
| Principal Investigator: Richard J Shaw | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Richard J Shaw | Stanford University |
| Principal Investigator: | Sarah McCue Horwitz | Stanford University |
More Information
No publications provided
| Responsible Party: | Richard J Shaw, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01307293 History of Changes |
| Other Study ID Numbers: | SU-02172011-7504 |
| Study First Received: | February 28, 2011 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013