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Behavioral Intervention
ACT for Infertility
N/A
Recruiting
Led By Rhonda Merwin, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up gad-2: weeks 2 (session 2), 3 (session 3), 4 (session 4), 5 (session 5), 7 (session 7), 8 (session 8), 9 (session 9), 10 (session 10), and 11 (session 11).
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if Acceptance and Commitment Therapy (ACT) can help infertility patients experiencing distress. Up to 10 patients will receive 12 therapy sessions. The study will look at how
Who is the study for?
This trial is for up to 10 individuals experiencing infertility and related psychological distress, such as depression or anxiety. Participants will engage in a therapy program called Acceptance and Commitment Therapy (ACT) for 12 sessions to see if it helps improve their emotional well-being.
What is being tested?
The study tests the effectiveness of Acceptance and Commitment Therapy (ACT), which includes 12 therapy sessions aimed at reducing psychological distress in people dealing with infertility. The goal is to assess whether ACT can enhance mood, reduce stress, and increase psychological flexibility.
What are the potential side effects?
As this trial involves psychological therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or increased awareness of distressing thoughts during the process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phq-2: weeks 2 (session 2), 3 (session 3), 4 (session 4), 5 (session 5), 7 (session 7), 8 (session 8), 9 (session 9), 10 (session 10), and 11 (session 11).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phq-2: weeks 2 (session 2), 3 (session 3), 4 (session 4), 5 (session 5), 7 (session 7), 8 (session 8), 9 (session 9), 10 (session 10), and 11 (session 11).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of the Intervention
Secondary study objectives
Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)
Change in Fertility Problem Inventory (FPI)
Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Acceptance and Commitment TherapyExperimental Treatment1 Intervention
For those that enroll in the study, the therapist will see patients for 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. The therapist will offer both in-person and virtual sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,542 Total Patients Enrolled
3 Trials studying Infertility
462 Patients Enrolled for Infertility
Rhonda Merwin, PhDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
313 Total Patients Enrolled
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