NCT00385346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 30, 2010

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

October 5, 2006

Last Update Submit

June 29, 2010

Conditions

Infertility, Male

Keywords

Expressive writingMale infertility

Outcome Measures

Primary Outcomes (1)

  • Scores on rating scale for perceived stress in infertility

    3 months

Secondary Outcomes (3)

  • Scores on rating scale for personality dimensions

    3 months

  • Sperm parameters

    3-12 months

  • Score on rating scale for coping

    3 months

Study Arms (1)

A 1

EXPERIMENTAL

Expressive writing

Behavioral: Expressive writing

Interventions

Expressive writingBEHAVIORAL

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.

A 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn, Department of Psychosomatic Medicine

Bonn, 53105, Germany

Location

Related Publications (8)

  • 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.

    PMID: 12552631BACKGROUND

  • 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.

    PMID: 12433015BACKGROUND

  • 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.

    PMID: 15039514BACKGROUND

  • 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.

    PMID: 11227757BACKGROUND

  • 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.

    PMID: 10740948BACKGROUND

  • 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.

    PMID: 9866186BACKGROUND

  • 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.

    PMID: 7593871BACKGROUND

  • 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.

    PMID: 3372832BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Reinhard Liedtke, MD

    University of Bonn, Department of Psychosomatic Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 9, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

February 1, 2009

Last Updated

June 30, 2010

Record last verified: 2009-09

Locations

DE(1)