Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE)

Grupo Lusófona

Status: Not yet enrolling

Conditions: Intervention; Control Group

Treatments: Behavioral: PORTiSOFIE

Study type: Interventional

Funder types: Other

Identifiers

NCT06767878

2024.03961.BD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for participants:

• 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).

Inclusion Criteria for partners:

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: PORTiSOFIE

Attention Group

Other group

Description:

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.

Treatment:

Behavioral: PORTiSOFIE