Expressive Writing in Male Infertility - Full Text View

Purpose

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	Intervention
Infertility, Male	Behavioral: Expressive writing

MedlinePlus related topics:

Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Expressive Writing as a Therapeutic Intervention in Male Infertility

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

Scores on rating scales for perceived stress in infertility [ Time Frame: 4 weeks and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores on rating scales for personality dimensions and coping [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Sperm parameters [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A 1: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385346

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

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. No abstract available.

Responsible Party:	University of Bonn ( Prof. Dr. R. Liedtke, Department of Psychosomatic Medicine and Psychotherapy )
Study ID Numbers:	Lfd.Nr.068/06
First Received:	October 5, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00385346
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:

Expressive writing

Male infertility

Study placed in the following topic categories:

Genital Diseases, Female

Infertility

Infertility, Male

Genital Diseases, Male

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	University Hospital, Bonn
Information provided by:	University Hospital, Bonn
ClinicalTrials.gov Identifier:	NCT00385346