Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Positive Adjustment Coping Intervention (PACI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118219
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Maren Schick, University Hospital Heidelberg

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE July 18, 2017
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Positive Adjustment Coping Intervention
Official Title  ICMJE Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Infertility/Sterility
Intervention  ICMJE
  • Other: Positive adjustment coping intervention
    see arm description
  • Other: Brainteaser
    see arm description
    Other Name: Comparison intervention group
Study Arms  ICMJE
  • 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.
    Intervention: Other: Positive adjustment coping intervention
  • 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.
    Intervention: Other: Brainteaser
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
401
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
240
Actual Study Completion Date  ICMJE August 8, 2019
Actual Primary Completion Date June 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118219
Other Study ID Numbers  ICMJE S-074/2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maren Schick, University Hospital Heidelberg
Study Sponsor  ICMJE University Hospital Heidelberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tewes Wischmann, PD Dr. University Hospital Heidelberg
PRS Account University Hospital Heidelberg
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP