Internet-based therapy for social anxiety in adults in Portugal (PORTiSOFIE) and its impact on sexual and relationship satisfaction: study protocol for a randomized controlled trial.
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| Titel: | Internet-based therapy for social anxiety in adults in Portugal (PORTiSOFIE) and its impact on sexual and relationship satisfaction: study protocol for a randomized controlled trial. |
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| Autoren: | Martins EM; HEI-Lab: Digital Human-Environment Interaction Labs, Lusófona University, Lisbon, Portugal., Pascoal PM; HEI-Lab: Digital Human-Environment Interaction Labs, Lusófona University, Lisbon, Portugal.; Clínica Universitária de Psiquiatria e Psicologia Médica, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.; PSYLAB, Instituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal., Pereira M; Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden., Andersson G; HEI-Lab: Digital Human-Environment Interaction Labs, Lusófona University, Lisbon, Portugal. Gerhard.Andersson@liu.se.; Center for Research in Neuropsychology and Cognitive and Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal. Gerhard.Andersson@liu.se. |
| Quelle: | Trials [Trials] 2025 Nov 06; Vol. 26 (1), pp. 476. Date of Electronic Publication: 2025 Nov 06. |
| Publikationsart: | Journal Article; Clinical Trial Protocol |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| MeSH-Schlagworte: | Cognitive Behavioral Therapy*/methods , Phobia, Social*/therapy , Phobia, Social*/psychology , Phobia, Social*/diagnosis , Internet-Based Intervention* , Sexual Behavior*/psychology , Personal Satisfaction* , Interpersonal Relations*, Humans ; Portugal ; Randomized Controlled Trials as Topic ; Adult ; Treatment Outcome ; Male ; Female ; Young Adult ; Internet |
| Abstract: | Competing Interests: Declarations. Ethics approval and consent to participate {24}: The study was submitted for ethical approval to the Ethics and Deontology Committee for Scientific Research (CEDIC) of the School of Psychology and Life Sciences of Lusófona University. Ref. CEDIC-2024-16-17. Consent for publication {32}: Not applicable. Competing interests {28}: The authors declare that they have no competing interests. Background: Social anxiety disorder (SAD) is a common condition that affects intrapersonal (e.g., distress and impairment) and interpersonal functioning (e.g., difficulties in amorous relationships). People with SAD tend to have difficulties in communicating feelings to partners and report lower levels of sexual and relationship satisfaction. Cognitive behavioral therapy (CBT) for SAD has been found to reduce symptoms of social anxiety, but less is known about its impact on relationship functioning. Internet-based CBT (iCBT) has gained attention for its primary advantage: bridging distances and saving time for the patient. In the planned study, we aim to translate and culturally adapt an iCBT program for social anxiety for use in Portugal (PORTiSOFIE) and measure the effects of the program on social anxiety symptoms. We will also study the impact on sexual and relationship satisfaction, as well as other relationship- relevant outcomes. Methods: We will conduct a randomized controlled trial and divide participants in a two-arm study with parallel groups (i.e., intervention group and attention group). After allocation, the intervention group will receive treatment, while the control group (i.e., attention group) will receive treatment 9 weeks later. The treatment is based on the Clark and Wells model of social phobia and consists of nine modules, with one module completed each week. Participants will answer questionnaires to assess social anxiety symptoms and relationship outcomes at pre-treatment, post-treatment, and 6-month follow-up. Participants' partners will also be asked to complete questionnaires on the same periods of time, but only regarding relationship outcomes. Discussion: iCBT for SAD in adults has not yet been tested in Portugal, and overall, there is a gap in the literature regarding the role of partners in iCBT for SAD. We hope our study contributes to increasing accessibility to therapy (and better mental health) by promoting online evidence-based therapies. In addition, we hope it helps to better understand how relationship components are affected and affect clinical symptoms and their progression within receiving treatment. Trial Registration: ClinicalTrials.gov NCT06767878. Registered on January 10, 2025. (© 2025. The Author(s).) |
| References: | Internet Interv. 2018 May 31;13:24-29. (PMID: 30206515) J Anxiety Disord. 2018 Apr;55:70-78. (PMID: 29422409) N Engl J Med. 2017 Jun 8;376(23):2255-2264. (PMID: 28591542) Curr Psychiatry Rep. 2015 Jan;17(1):531. (PMID: 25413637) Cogn Behav Ther. 2018 Jan;47(1):1-18. (PMID: 29215315) J Consult Clin Psychol. 2015 Dec;83(6):1108-22. (PMID: 26302248) World Psychiatry. 2023 Jun;22(2):305-314. (PMID: 37159350) PLoS One. 2015 May 04;10(5):e0123997. (PMID: 25938241) Br J Psychiatry. 2000 Apr;176:379-86. (PMID: 10827888) Front Psychol. 2023 Jan 10;13:915677. (PMID: 36755977) JMIR Ment Health. 2020 Apr 6;7(4):e16817. (PMID: 32250273) J Clin Psychol. 2014 Jun;70(6):546-61. (PMID: 24122480) Lancet Psychiatry. 2014 Oct;1(5):368-76. (PMID: 26361000) Arch Sex Behav. 2013 Jan;42(1):81-91. (PMID: 22476519) Clin Psychol Psychother. 2021 May;28(3):656-668. (PMID: 33142004) |
| Contributed Indexing: | Keywords: Internet-based intervention; Relationship satisfaction; Sexual satisfaction; Social anxiety |
| Molecular Sequence: | ClinicalTrials.gov NCT06767878 |
| Entry Date(s): | Date Created: 20251106 Date Completed: 20251107 Latest Revision: 20251110 |
| Update Code: | 20251110 |
| PubMed Central ID: | PMC12590898 |
| DOI: | 10.1186/s13063-025-09103-2 |
| PMID: | 41199378 |
| Datenbank: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Declarations. Ethics approval and consent to participate {24}: The study was submitted for ethical approval to the Ethics and Deontology Committee for Scientific Research (CEDIC) of the School of Psychology and Life Sciences of Lusófona University. Ref. CEDIC-2024-16-17. Consent for publication {32}: Not applicable. Competing interests {28}: The authors declare that they have no competing interests.<br />Background: Social anxiety disorder (SAD) is a common condition that affects intrapersonal (e.g., distress and impairment) and interpersonal functioning (e.g., difficulties in amorous relationships). People with SAD tend to have difficulties in communicating feelings to partners and report lower levels of sexual and relationship satisfaction. Cognitive behavioral therapy (CBT) for SAD has been found to reduce symptoms of social anxiety, but less is known about its impact on relationship functioning. Internet-based CBT (iCBT) has gained attention for its primary advantage: bridging distances and saving time for the patient. In the planned study, we aim to translate and culturally adapt an iCBT program for social anxiety for use in Portugal (PORTiSOFIE) and measure the effects of the program on social anxiety symptoms. We will also study the impact on sexual and relationship satisfaction, as well as other relationship- relevant outcomes.<br />Methods: We will conduct a randomized controlled trial and divide participants in a two-arm study with parallel groups (i.e., intervention group and attention group). After allocation, the intervention group will receive treatment, while the control group (i.e., attention group) will receive treatment 9 weeks later. The treatment is based on the Clark and Wells model of social phobia and consists of nine modules, with one module completed each week. Participants will answer questionnaires to assess social anxiety symptoms and relationship outcomes at pre-treatment, post-treatment, and 6-month follow-up. Participants' partners will also be asked to complete questionnaires on the same periods of time, but only regarding relationship outcomes.<br />Discussion: iCBT for SAD in adults has not yet been tested in Portugal, and overall, there is a gap in the literature regarding the role of partners in iCBT for SAD. We hope our study contributes to increasing accessibility to therapy (and better mental health) by promoting online evidence-based therapies. In addition, we hope it helps to better understand how relationship components are affected and affect clinical symptoms and their progression within receiving treatment.<br />Trial Registration: ClinicalTrials.gov NCT06767878. Registered on January 10, 2025.<br /> (© 2025. The Author(s).) |
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| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-025-09103-2 |