Clinical trial NCT06767878: Internet Delivered Therapy for Social Anxiety in Adults
Official title: Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE): Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Control Group
Intervention
Keywords: Social Anxiety
internet delivered CBT
Relationship satisfaction
Sexual satisfaction
Lead sponsor: Grupo Lusófona
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Liebowitz Social Anxiety Scale for Adults (LSAS)
timeFrame: through study completion, an average of 1 year
measure: Social Phobia Inventory (SPIN)
timeFrame: through study completion, an average of 1 year
measure: Global Measure of Relationship Satisfaction (GMREL)
timeFrame: through study completion, an average of 1 year
measure: Global Measure of Sexual Satisfaction (GMSEX)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Revised Dyadic Adjustment Scale (RDAS)
timeFrame: through study completion, an average of 1 year
measure: Inclusion of Other in the Self Scale (IOS)
timeFrame: through study completion, an average of 1 year
measure: Difficulties in Interpersonal Emotion Regulation (DIRE)
timeFrame: through study completion, an average of 1 year
measure: Personal Assessment of Intimacy in Relationships (PAIR)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Universidade Lusófona
Study officials:
References: