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NCT Number: NCT06767878

Internet Delivered Therapy for Social Anxiety in Adults

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Lusófona

Lisbon, Portugal

Location contact

Patrícia Pascoal, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PORTiSOFIE

Behavioral

This treatment is based on the Clark and Wells model of social phobia, and it is constituted by 9 modules:

  • Introduction of the program and overview of social anxiety disorder and symptoms
  • Negative automatic thoughts
  • Challenging negative automatic thoughts
  • Behavioral experiments
  • Exposure
  • Exposure and self-focus attention
  • Exposure and get closer to fears
  • Social skill training
  • Maintenance plan

Primary outcomes

  1. Liebowitz Social Anxiety Scale for Adults (LSAS)

    Time frame: through study completion, an average of 1 year

    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).

  2. Social Phobia Inventory (SPIN)

    Time frame: through study completion, an average of 1 year

    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.

  3. Global Measure of Relationship Satisfaction (GMREL)

    Time frame: through study completion, an average of 1 year

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

  4. Global Measure of Sexual Satisfaction (GMSEX)

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Revised Dyadic Adjustment Scale (RDAS)

    Time frame: through study completion, an average of 1 year

    3 subscales: consensus, satisfaction, cohesion. It is a 14-item measure, that asks people to rate aspects of the relationship on a 5 or 6 point scale. Total scores range between zero and 69, with higher values indicating greater adjustment.

  2. Inclusion of Other in the Self Scale (IOS)

    Time frame: through study completion, an average of 1 year

    A single-item pictorial measure, that measures how close the respondent feels with another person (in this case the amorous partner).

  3. Difficulties in Interpersonal Emotion Regulation (DIRE)

    Time frame: through study completion, an average of 1 year

    It has two subscales: venting and reassurance-seeking, constituted by a total of 24 items. Three hypothetic situations are presented, and for each one, the respondent must indicate how the situation is perceived on a scale from 0 (not at all distress) to 100 (extremely distressed). Then, for each of the scenarios, is asked the likelihood (i.e., 4-point Likert scale) of responding in 7 different presented ways. Higher scores indicate higher levels of difficulties in Interpersonal emotion regulation strategies.

  4. Personal Assessment of Intimacy in Relationships (PAIR)

    Time frame: through study completion, an average of 1 year

    is constituted by 36 items, responded in a 5-point Likert scale (from 1 "strongly disagree" to 5 "strongly agree"), with 18 items being reversed scored, so that higher values correspond to higher levels of intimacy. For the present study, only the communication subscale with 10 items will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Edna M Martins

CONTACT

[email protected]

+351918792199

Sponsors and collaborators

Lead sponsor

Grupo Lusófona

Other

Registry information

Official study title

Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE): Study Protocol for a Randomized Controlled Trial

Acronym: PORTiSOFIE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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