Expressive Writing in Male Infertility - Full Text View

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Expressive Writing as a Therapeutic Intervention in Male Infertility

Resource links provided by NLM:

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility sensorineural deafness and male infertility Y chromosome infertility

MedlinePlus related topics: Infertility Male Infertility

U.S. FDA Resources

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	56
Study Start Date:	November 2006
Study Completion Date:	February 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

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:	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
Study First Received:	October 5, 2006
Last Updated:	June 29, 2010
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:

Expressive writing
Male infertility

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 09, 2012