Depression Clinical Trial
— YiNOfficial title:
Yoga in the NICU for Parents (YiN): a Clinical Pilot Study
Verified date | May 2024 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this proposal is to test the efficacy of yoga as a mind and body intervention to decrease stress, anxiety, and depression in parents of critically ill neonates hospitalized in the Seattle Children's and University of Washington neonatal intensive care units (NICUs).
Status | Completed |
Enrollment | 51 |
Est. completion date | January 31, 2024 |
Est. primary completion date | October 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - NICU inpatients born <32 weeks gestation at birth and/or <1500g, OR estimated length of stay =6 weeks - Parents of current NICU inpatients born <32 weeks gestation at birth and/or <1500g OR estimated length of stay =6 weeks - Parents with any level of experience with yoga (none to regular practitioner) - Child has been admitted to the NICU for at least 10 days - Parent age =18 years - Parent speaks and reads in either English or Spanish Exclusion Criteria: - Expected length of stay of NICU inpatient <6 weeks - Parent does not speak or read in English only speaks or reads in a language other than English or Spanish - Parent plans to relinquish child - Child or parents are too unstable as assessed by the Attending Physician |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Hospital | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | University of Washington |
United States,
Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4. — View Citation
Cramer H, Anheyer D, Lauche R, Dobos G. A systematic review of yoga for major depressive disorder. J Affect Disord. 2017 Apr 15;213:70-77. doi: 10.1016/j.jad.2017.02.006. Epub 2017 Feb 7. — View Citation
Cramer H, Anheyer D, Saha FJ, Dobos G. Yoga for posttraumatic stress disorder - a systematic review and meta-analysis. BMC Psychiatry. 2018 Mar 22;18(1):72. doi: 10.1186/s12888-018-1650-x. — View Citation
Cramer H, Lauche R, Anheyer D, Pilkington K, de Manincor M, Dobos G, Ward L. Yoga for anxiety: A systematic review and meta-analysis of randomized controlled trials. Depress Anxiety. 2018 Sep;35(9):830-843. doi: 10.1002/da.22762. Epub 2018 Apr 26. — View Citation
de Cock ESA, Henrichs J, Klimstra TA, Janneke B M Maas A, Vreeswijk CMJM, Meeus WHJ, van Bakel HJA. Longitudinal Associations Between Parental Bonding, Parenting Stress, and Executive Functioning in Toddlerhood. J Child Fam Stud. 2017;26(6):1723-1733. doi: 10.1007/s10826-017-0679-7. Epub 2017 Feb 27. — View Citation
Kerstis B, Aarts C, Tillman C, Persson H, Engstrom G, Edlund B, Ohrvik J, Sylven S, Skalkidou A. Association between parental depressive symptoms and impaired bonding with the infant. Arch Womens Ment Health. 2016 Feb;19(1):87-94. doi: 10.1007/s00737-015-0522-3. Epub 2015 Apr 10. — View Citation
Matthey S, Barnett B, Kavanagh DJ, Howie P. Validation of the Edinburgh Postnatal Depression Scale for men, and comparison of item endorsement with their partners. J Affect Disord. 2001 May;64(2-3):175-84. doi: 10.1016/s0165-0327(00)00236-6. — View Citation
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Pace CC, Spittle AJ, Molesworth CM, Lee KJ, Northam EA, Cheong JL, Davis PG, Doyle LW, Treyvaud K, Anderson PJ. Evolution of Depression and Anxiety Symptoms in Parents of Very Preterm Infants During the Newborn Period. JAMA Pediatr. 2016 Sep 1;170(9):863-70. doi: 10.1001/jamapediatrics.2016.0810. — View Citation
Treyvaud K, Anderson VA, Howard K, Bear M, Hunt RW, Doyle LW, Inder TE, Woodward L, Anderson PJ. Parenting behavior is associated with the early neurobehavioral development of very preterm children. Pediatrics. 2009 Feb;123(2):555-61. doi: 10.1542/peds.2008-0477. — View Citation
Treyvaud K, Anderson VA, Lee KJ, Woodward LJ, Newnham C, Inder TE, Doyle LW, Anderson PJ. Parental mental health and early social-emotional development of children born very preterm. J Pediatr Psychol. 2010 Aug;35(7):768-77. doi: 10.1093/jpepsy/jsp109. Epub 2009 Dec 2. — View Citation
Treyvaud K, Spittle A, Anderson PJ, O'Brien K. A multilayered approach is needed in the NICU to support parents after the preterm birth of their infant. Early Hum Dev. 2019 Dec;139:104838. doi: 10.1016/j.earlhumdev.2019.104838. Epub 2019 Aug 27. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in parental depression, anxiety and stress score over time | The depression, anxiety & stress scale (DASS-21) is validated in English and Spanish and is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three sub scales (depression, anxiety and stress) contain 7 questions with answers valued on a scale of 0-3. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Each sub scale score is multiplied by 2 and totaled to generate a DASS 21 score. Analysis will include mean/SD and median of total score and comparison of median DASS 21 score between pre and post-intervention. A high score on the DASS 21 means worse depression, anxiety and stress. | Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study | |
Primary | Measure of NICU parent stress | The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) is a 26-item self-report scale designed to measure the degree of stress experienced by parents during hospitalization. This scale has been validated in multiple languages including English and Spanish. Analysis will assess parents' overall level of stress engendered by the NICU environment. All individuals receive a score on each item, with those not having the experience (e.g N/A) receiving a "1" indicating no stress was experienced. Score will be generated by a total sum of: sub scale 1: Sights and Sounds (sum/5)+ sub scale 2: Infant behavior and appearance (sum/14)+ sub scale 3: Parental Role Alteration (sum/7). Analysis to include: mean/SD for each sub scale and mean/SD for total score for each participant. Mean scores on the PSS:NICU will be compared across the three time-points and between parents in each arm (intervention and control). A higher score on the PSS:NICU means higher NICU parent stress. | Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study | |
Primary | Measure of parent-child bonding | Postpartum Bonding Questionnaire (PBQ) was developed to detect mother-infant bonding disturbances in the postnatal period. Participants rate how often they agree with statements on a 6-point Likert scale ranging from always (score 0) to never (score 5) with low scores denoting good bonding. We plan to use 2 of the four sub scales (19-item self-report scale). A score of >/= 12 on scale 1 and >/= 13 on scale 2 indicates worse parent-child bonding. | Once after 6-weeks at the conclusion of the study | |
Secondary | Infant Length of Stay | Length of stay (days) from admission to discharge home or transfer to other institution, as documented on the discharge or transfer summary. | From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks. | |
Secondary | Length of assisted ventilation (days) | Length of time (days) that infant required either invasive or non-invasive ventilation, as documented on the discharge or transfer summary. | From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks. | |
Secondary | Breastfeeding at discharge | Documentation of whether infant is doing any breastfeeding at discharge (yes/no) as documented on the discharge summary. | At the date of discharge to home, up to a maximum of 32 weeks. | |
Secondary | Yoga class participation | Participation in the yoga intervention will be tracked on the study website to assess number of sessions started (n) | From randomization through the conclusion of the 6-week study period | |
Secondary | Duration of participation in yoga classes | Participation in the yoga intervention will be tracked on the study website to assess duration of participation (minutes). | From randomization through the conclusion of the 6-week study period | |
Secondary | Postpartum Depression | The Edinburgh Postnatal Depression Scale (EPDS) has been validated in both women and men, and consists of 10 questions. The total score is determined by adding together the scores for each of the 10 items. Cut-off scores ranged from 9 to13 points with higher scores indicating worse post-partum depression. EPDS is administered to mothers by the NICU social worker between day 10-14 of admission. Participating fathers will fill out an EPDS survey as part of enrollment in this study. | Up to 4 weeks after admission | |
Secondary | Parent Satisfaction with Yoga Intervention | Course completion study filled out by all participants at the conclusion of the study. There will be specific questions geared to the intervention group to qualitatively assess parent satisfaction with the yoga intervention. | Once after 6-weeks at the conclusion of the study |
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