Clinical trial NCT03118219: Positive Adjustment Coping Intervention
Official title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility/Sterility
Keywords: assisted reproductive technology
embryo transfer
online intervention
rct
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 401
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.

Detailed description: About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in Germany, which is experienced as "roller coaster of emotions". The positive effect of "face-to-face" counseling for couples with a desire for children has been proven. However, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling.

In this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design.

For this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention. In the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.In addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques.

Sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported.

No adverse effects or other risks are expected for the study participants.

Eligibility criteria: Inclusion Criteria:

All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have

* agreed to participate in the study
* indicated their mobile phone number
* sufficient knowledge of German language.

If one partner is refusing to participate, the other person may be admitted as an individual.

Exclusion Criteria:

* denial of participation
* non-existent smartphone
* insufficient knowledge of German language

Primary outcomes:
measure: Differences in the Screen IVF questionaire between the intervention groups
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Quantitative evaluation of participants' opinion about the intervention
timeFrame: through study completion, an average of 2 years
measure: Qualitative evaluation of participants' opinion about the intervention
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Tewes Wischmann, PD Dr.
role: STUDY_DIRECTOR
References:
citation: Lancastle D, Boivin J. A feasibility study of a brief coping intervention (PRCI) for the waiting period before a pregnancy test during fertility treatment. Hum Reprod. 2008 Oct;23(10):2299-307. doi: 10.1093/humrep/den257. Epub 2008 Jul 15.
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
citation: Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol. BMJ Open. 2019 Jul 9;9(7):e025288. doi: 10.1136/bmjopen-2018-025288.