NCT03118219

Positive Adjustment Coping Intervention

Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility/Sterility

Interventions

Type	Name	Description
OTHER	Positive adjustment coping intervention	see arm description
OTHER	Brainteaser	see arm description

Timeline

• Start date: 2017-07-18
• Primary completion: 2019-06-12
• Completion: 2019-08-08
• First posted: 2017-04-18
• Last updated: 2019-09-30

Locations

1 site across 1 country: Germany