Internet Delivered Therapy for Social Anxiety in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrupo Lusófona
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
PORTiSOFIE
BehavioralThis 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
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Attention GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
through study completion, an average of 1 year2
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.
Time frame
through study completion, an average of 1 year3
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).
Time frame
through study completion, an average of 1 year4
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
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).
Time frame
through study completion, an average of 1 year3
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.
Time frame
through study completion, an average of 1 year4
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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