The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women

NCT ID: NCT00685282

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-02-28

Brief Summary

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The general hypothesis of the research is that stress decreases fertility and that Cognitive Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize that stress has a detrimental effect on DNA integrity and that stress reduction will reduce DNA damage in the cell.

Detailed Description

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Conditions

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Infertility Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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COGNITIVE BEHAVIORAL INTERVENTIONS

PSYCHOLOGICAL INTERVENTIONS TO INCLUDE, RELAXATION, STRESS REDUCTION, GUIDED IMAGERY, BREATHING EXERCISES

Group Type OTHER

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.

Interventions

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Cognitive Behavioral Therapy

The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* women between the ages of 18-35 without children undergoing IVF treatment

Exclusion Criteria

* undergoing treatment for a DSM-IV axis I psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eitan Lunenfeld

Head of the IVF Unit at the Soroka Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eitan Lunenfeld, PHD MD

Role: STUDY_CHAIR

Soroka UMC

Julie Cwikel, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Orly Sarid, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Iris Harvardi, PhD

Role: PRINCIPAL_INVESTIGATOR

Soroka UMC

Locations

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IVF Clinic Soroka UMC

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SOR469308CTIL

Identifier Type: -

Identifier Source: org_study_id

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