Control GroupPORTiSOFIENCT06767878
Internet Delivered Therapy for Social Anxiety in Adults
A study testing PORTiSOFIE in people with Control Group and Intervention, run by Grupo Lusófona at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Control Group, Intervention
- What is being tested?
- PORTiSOFIE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- Age 18 years or over
- Fluency in Portuguese
- Access to a device with internet.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Universidade Lusófona
Lisbon
Patrícia Pascoal, PhD, patricia.pascoal@ulusofona.pt
About this study
Official title: Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE): Study Protocol for a Randomized Controlled Trial
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.
Read the 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
- Being tested
- PORTiSOFIE
- Keywords
- Social Anxiety, internet delivered CBT, Relationship satisfaction, Sexual satisfaction
- Medical subject headings
- Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PORTiSOFIEBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PORTiSOFIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Revised Dyadic Adjustment Scale (RDAS)
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.
Measured: through study completion, an average of 1 year
Inclusion of Other in the Self Scale (IOS)
A single-item pictorial measure, that measures how close the respondent feels with another person (in this case the amorous partner).
Measured: through study completion, an average of 1 year
Difficulties in Interpersonal Emotion Regulation (DIRE)
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.
Measured: through study completion, an average of 1 year
Personal Assessment of Intimacy in Relationships (PAIR)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Control GroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Lusófona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edna Martins, Grupo Lusófona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767878
- Sponsor's protocol ID
- 2024.03961.BD
- Acronym
- PORTiSOFIE
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators plan to share anonymized data on request
Publications
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.
PubMed 41199378
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE): Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06767878
- Acronym / sponsor ID
- PORTiSOFIE / 2024.03961.BD
- Conditions
- Control Group, Intervention
- Keywords
- Social Anxiety, internet delivered CBT, Relationship satisfaction, Sexual satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Grupo LusófonaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PORTiSOFIEParticipants 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. |
| Attention Group | Other | Behavioral: PORTiSOFIEThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PORTiSOFIEThis 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 | Behavioural | Attention Group, Intervention Group |
Primary outcome
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).
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.
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).
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.
4 secondary outcomes
Revised Dyadic Adjustment Scale (RDAS)
Time frame: through study completion, an average of 1 year
Inclusion of Other in the Self Scale (IOS)
Time frame: through study completion, an average of 1 year
Difficulties in Interpersonal Emotion Regulation (DIRE)
Time frame: through study completion, an average of 1 year
Personal Assessment of Intimacy in Relationships (PAIR)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 41199378Martins 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.
- Individual participant dataSharing planned: Yes. Investigators plan to share anonymized data on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PORTiSOFIE in people with Control Group and Intervention, run by Grupo Lusófona at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edna M Martins (+351918792199, edna.martins@ulusofona.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale for Adults (LSAS) (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.