Internet-based treatment for vulvodynia (EMBLA) - Study protocol for a randomised controlled study.
ACT, Acceptance and commitment therapy
Acceptance and commitment therapy
BAI, Beck Anxiety Inventory
CBT, Cognitive Behavioural therapy
CPAQ, Chronic Pain Acceptance questionnaire
EQ5-D, EuroQol-5-dimension questionnaire
ESSI, ENRICHD Social Support Instrument
FSDS-R, Female Sexual Distress Scale – Revised
FSFI, Female Sexual Function Index
Internet-based
LOCF, last observation carried forward
MADRS-S, Montgomery-Åsberg Depression Rating Scale
Randomised controlled trial
SWLS, Satisfaction with Life Scale
Vulvodynia
rDAS, Revised Dyadic Adjustment Scale
Journal
Internet interventions
ISSN: 2214-7829
Titre abrégé: Internet Interv
Pays: Netherlands
ID NLM: 101631612
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
25
06
2020
revised:
10
04
2021
accepted:
12
04
2021
entrez:
17
5
2021
pubmed:
18
5
2021
medline:
18
5
2021
Statut:
epublish
Résumé
Vulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment. We will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively. As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies. NCT02809612.
Sections du résumé
BACKGROUND
BACKGROUND
Vulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment.
METHODS
METHODS
We will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively.
DISCUSSION
CONCLUSIONS
As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies.
TRIAL REGISTRATION NUMBER
BACKGROUND
NCT02809612.
Identifiants
pubmed: 33996511
doi: 10.1016/j.invent.2021.100396
pii: S2214-7829(21)00036-1
pmc: PMC8091887
doi:
Banques de données
ClinicalTrials.gov
['NCT02809612']
Types de publication
Journal Article
Langues
eng
Pagination
100396Informations de copyright
© 2021 The Author(s).
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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