Positive Adjustment Coping Intervention

Overview

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.

Full Title of Study: “Positive Adjustment in Case of Involuntary Childlessness – a Smartphone-supported Intervention Study as RCT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 12, 2019

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.

Interventions

  • Other: Positive adjustment coping intervention
    • see arm description
  • Other: Brainteaser
    • see arm description

Arms, Groups and Cohorts

  • Experimental: Positive adjustment coping intervention
    • All persons allocated to the intervention group will receive daily text messages (SMS) to their smartphones with sentences for positive adjustment over two weeks starting from the day of the egg-cell punctuation.
  • Other: Brainteaser
    • All persons allocated to the comparison intervention group will receive daily text messages (SMS) to their smartphones with brainteasers over two weeks starting from the day of the egg-cell punctuation.

Clinical Trial Outcome Measures

Primary Measures

  • Differences in the Screen IVF questionaire between the intervention groups
    • Time Frame: through study completion, an average of 2 years
    • Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers

Secondary Measures

  • Quantitative evaluation of participants’ opinion about the intervention
    • Time Frame: through study completion, an average of 2 years
    • Participants will be questioned about the perceived effectiveness and practicability of the intervention techniques with quantitative items (Rating scales).
  • Qualitative evaluation of participants’ opinion about the intervention
    • Time Frame: through study completion, an average of 2 years
    • Participants will be questioned about the recommendations to others concerning the intervention techniques (open questions)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Heidelberg
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maren Schick, Principal Investigator – University Hospital Heidelberg
  • Overall Official(s)
    • Tewes Wischmann, PD Dr., Study Director, University Hospital Heidelberg

References

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.

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