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Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial.

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.