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Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial.
Hum Reprod. 2019 07 08; 34(7):1235-1248.HR

Abstract

STUDY QUESTION

What is the effect of two guided self-administered interventions on psychological distress in women undergoing IVF or ICSI?

SUMMARY ANSWER

A brief mindfulness intervention significantly reduced depression and improved sleep quality, while the gratitude journal intervention showed no significant effect on any outcome variables.

WHAT IS KNOWN ALREADY

Mindfulness and gratitude journal interventions have been found to be beneficial in reducing negative affect and improving well-being. However, there are very few mental health professionals who implement such interventions in low- and middle-income countries. Therefore, two guided self-administered interventions for women with infertility were designed to help them cope with their psychological distress.

STUDY DESIGN, SIZE, DURATION

A three-armed, randomized controlled trial was designed to evaluate the mindfulness and gratitude journal interventions for women undergoing IVF/ICSI. Between May 2016 and November 2017, at the reproductive center in a public hospital, 234 women were randomly assigned to the brief mindfulness group (BMG, n = 78), gratitude journal group (GJG, n = 78) or control group (CG, n = 78). The inclusion criteria were being a woman undergoing her first cycle of IVF, having at least junior middle school education and having no biological or adopted children.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Female infertility patients (n = 346) were approached, and 112 did not meet the inclusion criteria. All three randomized groups completed questionnaires on the day of down-regulation (T1), the day before embryo(s) transfer (T2), and 3 days before the pregnancy test (T3). The BMG completed four sessions and listened to a 20-minute audio daily, including guided mindfulness breathing and body scan. The GJG completed four sessions and wrote three gratitude journals daily. The CG received routine care. A generalized estimating equation was used in an intention-to-treat analysis. The primary outcome was depression. Secondary outcomes were anxiety, sleep quality, infertility-related stress, mindfulness and gratitude.

MAIN RESULTS AND THE ROLE OF CHANCE

Participants of the BMG showed decreased depression (mean difference (MD) = -1.69, [-3.01, -0.37], d = 0.44) and improved sleep quality (MD = -1.24, [-1.95, -0.39], d = 0.43) compared to the CG, but the effect was not significant for anxiety, Fertility Problem Inventory totals, mindfulness, gratitude scores or pregnancy rates. The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3. There were no significant effects on any of the variables for the GJG.

LIMITATIONS, REASONS FOR CAUTION

The inclusion criteria may result in bias because some participants with low education were excluded and only women with infertility were included. A low compliance rate occurred in the gratitude journals group. Moreover, men were not included in this study. Further research should consider including spouses of the target population.

WIDER IMPLICATIONS OF THE FINDINGS

The brief mindfulness intervention was beneficial in decreasing depression and improving sleep quality. Implementation of guided self-administered mindfulness could make the psychological counseling service more accessible for patients with infertility in resource-poor settings. The efficiency and feasibility of the gratitude journal intervention needs to be investigated further.

STUDY FUNDING/COMPETING INTEREST(S)

This study was funded by the National Social Science Foundation (17BSH054). The authors have no conflicts of interest.

TRIAL REGISTRATION NUMBER

ChiCTR-IOR-16008452.

TRIAL REGISTRATION DATE

9 May 2016.

DATE OF FIRST PATIENT’S ENROLMENT

15 May 2016.

Authors+Show Affiliations

School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China. School of Nursing, Ningxia Medical University, 1160 Sheng Li Street, Yinchuan 750004, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.Reproductive Medicine Center, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.Nursing Department, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.School of Health Care Management, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.Reproductive Medicine Center, General Hospital of Ningxia Medical University, 804 Sheng Li Street, Yinchuan 750004, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.School of Nursing, Shandong University, No. 44 Wenhua Xi Road, Jinan 250012, China.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31242506

Citation

Bai, Cai-Feng, et al. "Effectiveness of Two Guided Self-administered Interventions for Psychological Distress Among Women With Infertility: a Three-armed, Randomized Controlled Trial." Human Reproduction (Oxford, England), vol. 34, no. 7, 2019, pp. 1235-1248.
Bai CF, Cui NX, Xu X, et al. Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial. Hum Reprod. 2019;34(7):1235-1248.
Bai, C. F., Cui, N. X., Xu, X., Mi, G. L., Sun, J. W., Shao, D., Li, J., Jiang, Y. Z., Yang, Q. Q., Zhang, X., & Cao, F. L. (2019). Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial. Human Reproduction (Oxford, England), 34(7), 1235-1248. https://doi.org/10.1093/humrep/dez066
Bai CF, et al. Effectiveness of Two Guided Self-administered Interventions for Psychological Distress Among Women With Infertility: a Three-armed, Randomized Controlled Trial. Hum Reprod. 2019 07 8;34(7):1235-1248. PubMed PMID: 31242506.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial. AU - Bai,Cai-Feng, AU - Cui,Nai-Xue, AU - Xu,Xian, AU - Mi,Guang-Li, AU - Sun,Ji-Wei, AU - Shao,Di, AU - Li,Jie, AU - Jiang,Yin-Zhi, AU - Yang,Qian-Qian, AU - Zhang,Xuan, AU - Cao,Feng-Lin, PY - 2018/11/25/received PY - 2019/04/03/revised PY - 2019/6/27/pubmed PY - 2020/7/21/medline PY - 2019/6/27/entrez KW - depression KW - gratitude KW - infertility KW - mindfulness KW - randomized controlled trial KW - sleep quality SP - 1235 EP - 1248 JF - Human reproduction (Oxford, England) JO - Hum Reprod VL - 34 IS - 7 N2 - STUDY QUESTION: What is the effect of two guided self-administered interventions on psychological distress in women undergoing IVF or ICSI? SUMMARY ANSWER: A brief mindfulness intervention significantly reduced depression and improved sleep quality, while the gratitude journal intervention showed no significant effect on any outcome variables. WHAT IS KNOWN ALREADY: Mindfulness and gratitude journal interventions have been found to be beneficial in reducing negative affect and improving well-being. However, there are very few mental health professionals who implement such interventions in low- and middle-income countries. Therefore, two guided self-administered interventions for women with infertility were designed to help them cope with their psychological distress. STUDY DESIGN, SIZE, DURATION: A three-armed, randomized controlled trial was designed to evaluate the mindfulness and gratitude journal interventions for women undergoing IVF/ICSI. Between May 2016 and November 2017, at the reproductive center in a public hospital, 234 women were randomly assigned to the brief mindfulness group (BMG, n = 78), gratitude journal group (GJG, n = 78) or control group (CG, n = 78). The inclusion criteria were being a woman undergoing her first cycle of IVF, having at least junior middle school education and having no biological or adopted children. PARTICIPANTS/MATERIALS, SETTING, METHODS: Female infertility patients (n = 346) were approached, and 112 did not meet the inclusion criteria. All three randomized groups completed questionnaires on the day of down-regulation (T1), the day before embryo(s) transfer (T2), and 3 days before the pregnancy test (T3). The BMG completed four sessions and listened to a 20-minute audio daily, including guided mindfulness breathing and body scan. The GJG completed four sessions and wrote three gratitude journals daily. The CG received routine care. A generalized estimating equation was used in an intention-to-treat analysis. The primary outcome was depression. Secondary outcomes were anxiety, sleep quality, infertility-related stress, mindfulness and gratitude. MAIN RESULTS AND THE ROLE OF CHANCE: Participants of the BMG showed decreased depression (mean difference (MD) = -1.69, [-3.01, -0.37], d = 0.44) and improved sleep quality (MD = -1.24, [-1.95, -0.39], d = 0.43) compared to the CG, but the effect was not significant for anxiety, Fertility Problem Inventory totals, mindfulness, gratitude scores or pregnancy rates. The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3. There were no significant effects on any of the variables for the GJG. LIMITATIONS, REASONS FOR CAUTION: The inclusion criteria may result in bias because some participants with low education were excluded and only women with infertility were included. A low compliance rate occurred in the gratitude journals group. Moreover, men were not included in this study. Further research should consider including spouses of the target population. WIDER IMPLICATIONS OF THE FINDINGS: The brief mindfulness intervention was beneficial in decreasing depression and improving sleep quality. Implementation of guided self-administered mindfulness could make the psychological counseling service more accessible for patients with infertility in resource-poor settings. The efficiency and feasibility of the gratitude journal intervention needs to be investigated further. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by the National Social Science Foundation (17BSH054). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16008452. TRIAL REGISTRATION DATE: 9 May 2016. DATE OF FIRST PATIENT’S ENROLMENT: 15 May 2016. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/31242506/Effectiveness_of_two_guided_self_administered_interventions_for_psychological_distress_among_women_with_infertility:_a_three_armed_randomized_controlled_trial_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dez066 DB - PRIME DP - Unbound Medicine ER -