Internet Delivered Therapy for Social Anxiety in Adults (PORTiSOFIE): Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale for Adults (LSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Liebowitz Social Anxiety Scale for Adults (LSAS)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Revised Dyadic Adjustment Scale (RDAS)(through study completion, an average of 1 year)
- Inclusion of Other in the Self Scale (IOS)(through study completion, an average of 1 year)
- Difficulties in Interpersonal Emotion Regulation (DIRE)(through study completion, an average of 1 year)
- Personal Assessment of Intimacy in Relationships (PAIR)(through study completion, an average of 1 year)
研究者
Edna Martins
Principal Investigator
Grupo Lusófona