Expressive Writing in Male Infertility

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine whether expressive writing can be effective in improving the well-being and sperm quality in patients with male infertility.

Condition or disease	Intervention/treatment	Phase
Infertility, Male	Behavioral: Expressive writing	Not Applicable

Detailed Description:

Expressive writing is a therapeutic intervention designed by the psychologist James W. Pennebaker. Individuals write on three days for about 20 minutes about particularly stressful experiences in their life. Several studies showed that expressive writing can have beneficial effects on the frequency of health care utilization and well-being. Particularly in patients with rheumatism, kidney cancer and posttraumatic stress disorder expressive writing showed an positive effect on subjective well-being. Furthermore, in several studies expressive writing showed a positive effect on immune parameters.

As many studies suggest an important negative effect of stress on well-being and sperm parameters in male infertility, we want to investigate the effect of expressive writing in male infertility.The expressive writing condition is compared to a non emotional writing condition, in which individuals write about mainly non emotional topics such as time management. In this randomized-controlled trial subjects were allocated sequentially by block wise randomization (block size of 4). For randomization a computer generated random list was used. The allocation was concealed in a series of numbered sealed envelopes. The envelope was opened immediately before the first writing session.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Expressive Writing as a Therapeutic Intervention in Male Infertility
Study Start Date :	November 2006
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	February 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: A 1; Expressive writing	Behavioral: Expressive writing; Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Scores on rating scale for perceived stress in infertility [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Scores on rating scale for personality dimensions [ Time Frame: 3 months ]
2. Sperm parameters [ Time Frame: 3-12 months ]
3. Score on rating scale for coping [ Time Frame: 3 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male infertile patients with a pathological spermiogram according to WHO criteria

Exclusion Criteria:

• Drugs affecting sperm quality
• Patients with chromosomal anomalies affecting sperm quality (e.g. Klinefelter- Syndrome)
• Severe Psychiatric disorder defined as psychotic disorder (schizophrenia, bipolar disorder) or substance-related disorder
• Patients currently in psychotherapeutic or psychiatric therapy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
University of Bonn, Department of Psychosomatic Medicine
Bonn, Germany, 53105

Sponsors and Collaborators

University Hospital, Bonn

Investigators

Study Chair:	Reinhard Liedtke, MD	University of Bonn, Department of Psychosomatic Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Smyth J, Helm R. Focused expressive writing as self-help for stress and trauma. J Clin Psychol. 2003 Feb;59(2):227-35. Review.

de Moor C, Sterner J, Hall M, Warneke C, Gilani Z, Amato R, Cohen L. A pilot study of the effects of expressive writing on psychological and behavioral adjustment in patients enrolled in a Phase II trial of vaccine therapy for metastatic renal cell carcinoma. Health Psychol. 2002 Nov;21(6):615-9.

Petrie KJ, Fontanilla I, Thomas MG, Booth RJ, Pennebaker JW. Effect of written emotional expression on immune function in patients with human immunodeficiency virus infection: a randomized trial. Psychosom Med. 2004 Mar-Apr;66(2):272-5.

Pennebaker JW. The effects of traumatic disclosure on physical and mental health: the values of writing and talking about upsetting events. Int J Emerg Ment Health. 1999 Winter;1(1):9-18. Review.

Richards JM, Beal WE, Seagal JD, Pennebaker JW. Effects of disclosure of traumatic events on illness behavior among psychiatric prison inmates. J Abnorm Psychol. 2000 Feb;109(1):156-60.

Petrie KJ, Booth RJ, Pennebaker JW. The immunological effects of thought suppression. J Pers Soc Psychol. 1998 Nov;75(5):1264-72.

Petrie KJ, Booth RJ, Pennebaker JW, Davison KP, Thomas MG. Disclosure of trauma and immune response to a hepatitis B vaccination program. J Consult Clin Psychol. 1995 Oct;63(5):787-92.

Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988 Apr;56(2):239-45.

Responsible Party:	Prof. Dr. R. Liedtke, Department of Psychosomatic Medicine and Psychotherapy, University of Bonn
ClinicalTrials.gov Identifier:	NCT00385346 History of Changes
Other Study ID Numbers:	Lfd.Nr.068/06
First Posted:	October 9, 2006
Last Update Posted:	June 30, 2010
Last Verified:	September 2009

Keywords provided by University Hospital, Bonn:

Expressive writing; Male infertility

Additional relevant MeSH terms:

Infertility; Infertility, Male; Genital Diseases, Male; Genital Diseases, Female