Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol

Abstract

IntroductionInfertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting period following embryo transfer, which couples say is the most stressful period during treatment. However, at this specific phase, psychosocial counselling is not always available on the spot. The aim of this randomised controlled trial (RCT) study was to test the Positive Adjustment Coping Intervention (PACI), a low-dose, smartphone-supported psychological intervention for women and men undergoing fertility treatment.Methods and analysisThe effectiveness of PACI is tested by means of a prospective two-arm RCT. During the 14-day waiting period between oocyte puncture/oocyte thawing and pregnancy test, participants are randomly assigned to one of the two groups, and both women and men receive daily text messages on their smartphones. One group receives text messages with statements reflecting positive-adjustment coping attitudes, the other group messages containing cognitive distractions. The primary outcome of this study is the reduction of psychosocial burden during the waiting period of reproductive treatment. Furthermore, we want to assess whether there are differences between the interventions in a pre-post assessment. The secondary outcomes are information on perceived effectiveness and practicability of the intervention one month after the waiting period.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Heidelberg University Faculty of Medicine (S-074/2017). Study findings are planned for dissemination via peer-reviewed journal articles and at national and international conferences.Trial registration numberNCT03118219; Pre-results.Protocol versionVersion 2.0 dated 18/02/2019.

Development and evaluation of couple-based coping strategies with infertility: a protocol for a mixed-methods study

“…One study evaluated the effect of Positive Adjustment Coping Intervention using a smartphone to provide psychological support to women undergoing infertility treatment and found that the program was associated with a reduction in women’s psychological burden during treatment [ 25 ]. Moreover, the positive effect of cognitive-behavioral interventions on stress reduction in women undergoing assisted reproductive technology has been reported [ 24 ].…”

Supporting the treatment of infertility using psychological methods

“…Therefore, psychological interventions for self-administration have been developed, which have many advantages. These interventions are easily available and do not require time and financial outlays [48].…”

Predictors for the Early Termination of a Psychological Intervention During Treatment with Assisted Reproductive Technologies

“…Nach vorgenommener Randomisierung der Paare und dem Beginn des reproduktionsmedizinischen Behandlungszyklus begann parallel der computergestützte 13-tägige SMS-Versand. Die IG erhielt die oben beschriebene "Technik der positiven Ausrichtung" (PAKI) [2,29]. Diese ProbandInnen erhielten ab der Eizellpunktion jeden Mittag einen Satz auf ihr Smartphone geschickt, der eine positive Ausrichtung der Gedanken erzeugen sollte, bspw.…”

“…Die Studie wurde durch die Ethikkommission der Medizinischen Fakultät Heidelberg geprüft und genehmigt (Studie S-074/ 2017). Alle Studiendetails können auf clinicaltrials.org unter NCT03118219 eingesehen werden und in [29].…”