Internet Delivered Therapy for Social Anxiety in Adults

NCT06767878 | Not Yet Recruiting DMC

• 1 other identifier: 2024.03961.BD
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an internet-delivered CBT protocol for social anxiety in adults (PORTiSOFIE) is effective in Portugal. It will also learn about the impact that PORTiSOFIE may have on relationship dimensions of these individuals. The main questions it aims to answer are: Does PORTiSOFIE is effective? What impact PORTiSOFIE has in relationship dimensions? Participants will: Be assigned to experimental group and receive intervention briefly after screening is complete; Or control group and only receive intervention after the experimental group finishes.

Conditions

Control Group; Intervention

Keywords

Social Anxiety; internet delivered CBT; Relationship satisfaction; Sexual satisfaction

Outcome Measures

Primary Outcomes (4)

• Liebowitz Social Anxiety Scale for Adults (LSAS)

  It has 24 items, responded in a 4-point scale. Each item is rated regarding anxiety and avoidance, and so the total score of the scale ranges between 0 and 144, with higher scores indicating higher levels of social anxiety (i.e., below 40 - no discomfort; 40-55 - Mild social discomfort; 55-65 - Moderate social phobia; 65-80 - Marked social phobia; 80-95 - Severe social phobia; Above 95 - Very severe social phobia).

  through study completion, an average of 1 year

• Social Phobia Inventory (SPIN)

  Is composed by three subscales: fear, avoidance, and physical discomfort. There are 17 items in total (16 in the Portuguese version), assessing the symptoms of the previous. The scale is responded on a 4-point scale, and total score is between zero and 68, with higher scores indicating higher levels of social anxiety.

  through study completion, an average of 1 year

• Global Measure of Relationship Satisfaction (GMREL)

  Is constituted by 5 items responded in a 7-point Likert scale. Scores range between 5 (low relationship satisfaction) and 35 (high relationship satisfaction).

  through study completion, an average of 1 year

• Global Measure of Sexual Satisfaction (GMSEX)

  It has 5 items responded in a 7-point Likert scale, with total scores ranging from 5 to 25, with higher values indicating greater sexual satisfaction.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Revised Dyadic Adjustment Scale (RDAS)

  through study completion, an average of 1 year

• Inclusion of Other in the Self Scale (IOS)

  through study completion, an average of 1 year

• Difficulties in Interpersonal Emotion Regulation (DIRE)

  through study completion, an average of 1 year

• Personal Assessment of Intimacy in Relationships (PAIR)

  through study completion, an average of 1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will have access to the treatment (PORTiSOFIE). They will have a logg in for entering the platform and acess the modules, and the measures that need to be filled throughout the study.

Behavioral: PORTiSOFIE

Attention Group

OTHER

The control group will not receive the intervention while the experimental group goes through the protocol. Instead, they will have a weekly checkup with the therapists via the platform to monitor how they are feeling. After the experimental group finishes the intervention, if the PORTiSOFIE demonstrates preliminary indicators of effectiveness, investigators will offer it to the attention group.

Behavioral: PORTiSOFIE

Interventions

PORTiSOFIE BEHAVIORAL

This treatment is based on the Clark and Wells model of social phobia, and it is constituted by 9 modules: 1. Introduction of the program and overview of social anxiety disorder and symptoms 2. Negative automatic thoughts 3. Challenging negative automatic thoughts 4. Behavioral experiments 5. Exposure 6. Exposure and self-focus attention 7. Exposure and get closer to fears 8. Social skill training 9. Maintenance plan

Attention Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scores on the screening questionnaires indicating at least moderate levels of social anxiety.
• Age 18 years or over
• Fluency in Portuguese
• Access to a device with internet
• Be in a monogamous amorous relationship (regardless of sexual orientation)
• Not be receiving any ongoing treatment for social anxiety (e.g., stable antidepressants).
• Age 18 years or over
• Fluency in Portuguese
• Access to a device with internet.

You may not qualify if:

• Self-reported severe psychiatric disorders such as psychosis or personality disorder.
• Planned or ongoing medical treatments (e.g., surgery) and other personal circumstances that will interfere with the treatment (e.g., planned travel abroad).

Sponsors & Collaborators

• Grupo Lusófona: lead

Study Sites (1)

Universidade Lusófona

Lisbon, Portugal

Location

Related Publications (1)

• Martins EM, Pascoal PM, Pereira M, Andersson G. 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. Trials. 2025 Nov 6;26(1):476. doi: 10.1186/s13063-025-09103-2.

  PMID: 41199378 DERIVED

MeSH Terms

Conditions

Orgasm

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Central Study Contacts

Edna M Martins

CONTACT

+351918792199; edna.martins@ulusofona.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)