Expressive Writing in Male Infertility

Infertility, Male Clinical Trial

Official title:

Expressive Writing as a Therapeutic Intervention in Male Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385346
• Other study ID #: Lfd.Nr.068/06
• Status: Completed
• Phase: N/A
• First received: October 5, 2006
• Last updated: June 29, 2010
• Start date: November 2006
• Est. completion date: February 2009

Study information

• Verified date: September 2009
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Bonn, Department of Psychosomatic Medicine	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on rating scale for perceived stress in infertility		3 months	No
Secondary	Scores on rating scale for personality dimensions		3 months	No
Secondary	Sperm parameters		3-12 months	No
Secondary	Score on rating scale for coping		3 months	No