An Internet-based Information Platform for Vulvodynia Patients

NCT ID: NCT02809612

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-09-30

Brief Summary

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.

Conditions

Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based intervention

Patients randomized to the internet-based intervention will be given access to the information in the internet-based platform directly after randomization. During the first 6 weeks, information will be offered in a structured way, with a "theme" changing weekly. After this time-point, the patients will have the possibility to navigate through all information. The platform encompasses internet-based training including information on the disorder, psycho-education and information of simple self-implemented intervention strategies cope with vulvodynia and ameliorate dyspareunia. The platform will also include videos where team members will describe their role in treating patients with the disorder, but also short videos from former patients willing to share their individual stories.

Group Type: EXPERIMENTAL

Internet-based platform

Intervention Type: BEHAVIORAL

Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients

Control group

Patients randomized to the control group through the platform will immediately be informed about the fact that there is available information and resources on the internet and that they will be called for a visit to the physiotherapist-midwife at due time, according to the present guidelines of care followed in the respective clinic (Uppsala, Falun, Gävle).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based platform

Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study

Exclusion Criteria

• inability to read and understand Swedish
• severe mental illness
• currently in treatment for vulvodynia

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alkistis Skalkidou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Women's and Children's Health, Uppsala University

Locations

Gynecological Department, Akademiska Hospital

Uppsala, , Sweden

Countries

Sweden

References

Haefner HK. Report of the International Society for the Study of Vulvovaginal Disease terminology and classification of vulvodynia. J Low Genit Tract Dis. 2007 Jan;11(1):48-9. doi: 10.1097/01.lgt.0000225898.37090.04. No abstract available.

Reference Type: BACKGROUND

PMID: 17194952 (View on PubMed)

Arnold LD, Bachmann GA, Rosen R, Rhoads GG. Assessment of vulvodynia symptoms in a sample of US women: a prevalence survey with a nested case control study. Am J Obstet Gynecol. 2007 Feb;196(2):128.e1-6. doi: 10.1016/j.ajog.2006.07.047.

Reference Type: BACKGROUND

PMID: 17306651 (View on PubMed)

Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8.

Reference Type: BACKGROUND

PMID: 12744420 (View on PubMed)

Haefner HK, Collins ME, Davis GD, Edwards L, Foster DC, Hartmann ED, Kaufman RH, Lynch PJ, Margesson LJ, Moyal-Barracco M, Piper CK, Reed BD, Stewart EG, Wilkinson EJ. The vulvodynia guideline. J Low Genit Tract Dis. 2005 Jan;9(1):40-51. doi: 10.1097/00128360-200501000-00009.

Reference Type: BACKGROUND

PMID: 15870521 (View on PubMed)

Amstadter AB, Broman-Fulks J, Zinzow H, Ruggiero KJ, Cercone J. Internet-based interventions for traumatic stress-related mental health problems: a review and suggestion for future research. Clin Psychol Rev. 2009 Jul;29(5):410-20. doi: 10.1016/j.cpr.2009.04.001. Epub 2009 Apr 7.

Reference Type: BACKGROUND

PMID: 19403215 (View on PubMed)

Tursi MF, Baes Cv, Camacho FR, Tofoli SM, Juruena MF. Effectiveness of psychoeducation for depression: a systematic review. Aust N Z J Psychiatry. 2013 Nov;47(11):1019-31. doi: 10.1177/0004867413491154. Epub 2013 Jun 5.

Reference Type: BACKGROUND

PMID: 23739312 (View on PubMed)

Backman H, Widenbrant M, Bohm-Starke N, Dahlof LG. Combined physical and psychosexual therapy for provoked vestibulodynia-an evaluation of a multidisciplinary treatment model. J Sex Res. 2008 Oct-Dec;45(4):378-85. doi: 10.1080/00224490802398365.

Reference Type: BACKGROUND

PMID: 18937129 (View on PubMed)

Bohm-Starke N. Medical and physical predictors of localized provoked vulvodynia. Acta Obstet Gynecol Scand. 2010 Dec;89(12):1504-10. doi: 10.3109/00016349.2010.528368.

Reference Type: BACKGROUND

PMID: 21080898 (View on PubMed)

Heddini U, Bohm-Starke N, Nilsson KW, Johannesson U. Provoked vestibulodynia--medical factors and comorbidity associated with treatment outcome. J Sex Med. 2012 May;9(5):1400-6. doi: 10.1111/j.1743-6109.2012.02665.x. Epub 2012 Feb 29.

Reference Type: BACKGROUND

PMID: 22376009 (View on PubMed)

Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Provoked vestibulodynia: psychological predictors of topical and cognitive-behavioral treatment outcome. Behav Res Ther. 2010 Feb;48(2):106-15. doi: 10.1016/j.brat.2009.09.014. Epub 2009 Oct 7.

Reference Type: BACKGROUND

PMID: 19879555 (View on PubMed)

Wijma B, Wijma K. A Cognitive Behavioral Treatment Model of Vaginismus. Scand J Behav Ther 1997;26:147-156.

Reference Type: BACKGROUND

Palm A, Danielsson I. SFOGs ARG-rapport för tonårsgynekologi. Sexuell och reproduktiv hälsa hos ungdomar 2013:73-76.

Reference Type: BACKGROUND

Chapple CR, Zimmern PE, Brubaker L, Smith ARB, Bo K. Multidisciplinary Management of Female Pelvic Floor Disorders. Philadelphia: Churchill Livingstone Elsevier; 2006.

Reference Type: BACKGROUND

Hess Engstrom AH, Kullinger M, Jawad I, Hesselman S, Buhrman M, Hogberg U, Skalkidou A. Internet-based treatment for vulvodynia (EMBLA) - Study protocol for a randomised controlled study. Internet Interv. 2021 Apr 20;25:100396. doi: 10.1016/j.invent.2021.100396. eCollection 2021 Sep.

Reference Type: DERIVED

PMID: 33996511 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

EMBLA

Identifier Type: -

Identifier Source: org_study_id