Positive Adjustment Coping Intervention (PACI)

September 26, 2019 updated by: Maren Schick, University Hospital Heidelberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Positive adjustment coping intervention
see arm description
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.
Other: Brainteaser
see arm description
Other Names:
  • Comparison intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 2 years
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)
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Investigators

  • Study Director: Tewes Wischmann, PD Dr., University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2017

Primary Completion (ACTUAL)

June 12, 2019

Study Completion (ACTUAL)

August 8, 2019

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-074/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: Study Data can be requested per mail to Tewes Wischmann

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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