Internet Delivered Therapy for Social Anxiety in Adults

NCT ID: NCT06767878

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-06-30

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.

Detailed Description

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 with partners and report lower levels of relationship and sexual satisfaction. Cognitive behavioral therapy (CBT) for SAD has been found to redcuce 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 the investigators 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. The project will also study the impact on relationship satisfaction and other relevant outcomes. The investigators will conduct a randomized controlled trial and divide participants in a two-arm study with parallel groups (i.e., intervention group and wait-list group). Participants will answer questionnaires to assess social anxiety symptoms and relationship outcomes at pre-treatment, posttreatment and 6-month follow up. Participants partner's will also be asked to complete questionnaires on the same periods of time, but only regarding relationship outcomes. 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. The study will contribute to increase accessibility to therapy (and better mental health) by promoting online evidence-based therapies. Plus, it will help to better understand how relationship components are affected and affect clinical symptoms and their progression within receiving treatment.

Conditions

Control Group; Intervention

Study Design

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

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

PORTiSOFIE

Intervention Type: 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

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.

Group Type: OTHER

PORTiSOFIE

Intervention Type: 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

Interventions

PORTiSOFIE

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Lusófona

OTHER

Sponsor Role: lead

Responsible Party

Edna Martins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Lusófona

Lisbon, , Portugal

Countries

Portugal

Central Contacts

Edna M Martins

Role: CONTACT

edna.martins@ulusofona.pt

+351918792199

Facility Contacts

Patrícia Pascoal, PhD

Role: primary

patricia.pascoal@ulusofona.pt

Other Identifiers

2024.03961.BD

Identifier Type: -

Identifier Source: org_study_id