Clinical trial NCT00385346: Expressive Writing in Male Infertility
Official title: Expressive Writing as a Therapeutic Intervention in Male Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Keywords: Expressive writing
Male infertility
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2006-10-09
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Scores on rating scale for perceived stress in infertility
timeFrame: 3 months
Secondary outcomes:
measure: Scores on rating scale for personality dimensions
timeFrame: 3 months
measure: Sperm parameters
timeFrame: 3-12 months
measure: Score on rating scale for coping
timeFrame: 3 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Department of Psychosomatic Medicine
Study officials:
affiliation: University of Bonn, Department of Psychosomatic Medicine
name: Reinhard Liedtke, MD
role: STUDY_CHAIR
References:
citation: Smyth J, Helm R. Focused expressive writing as self-help for stress and trauma. J Clin Psychol. 2003 Feb;59(2):227-35. doi: 10.1002/jclp.10144.
citation: 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. doi: 10.1037//0278-6133.21.6.615.
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. doi: 10.1097/01.psy.0000116782.49850.d3.
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.
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. doi: 10.1037//0021-843x.109.1.156.
citation: Petrie KJ, Booth RJ, Pennebaker JW. The immunological effects of thought suppression. J Pers Soc Psychol. 1998 Nov;75(5):1264-72. doi: 10.1037//0022-3514.75.5.1264.
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. doi: 10.1037//0022-006x.63.5.787.
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. doi: 10.1037//0022-006x.56.2.239. No abstract available.