Social Anxiety Disorder
Conditions
Keywords
social anxiety, treatment, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Cognitive Therapy
Brief summary
The purpose of this study is to compare the efficacy of two variants of cognitive behavioral therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the treatment of generalized social anxiety disorder.
Detailed description
We are recruiting a clinical sample of patients who meet diagnostic criteria (per DSM-5) for the generalized subtype of social anxiety disorder. Participants are randomly assigned to the two active intervention conditions; no placebo or sham treatments will be employed. Assessments take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-months follow-up; participants also complete a brief weekly assessment of functioning. Treatment is administered individually by trained graduate students in clinical psychology, directly trained and supervised by the PI and Co-PI. Participants receive 12 weekly 1-hour long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed factorial design.
Interventions
BEHAVIORALCognitive Therapy
Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005).
BEHAVIORALAcceptance and Commitment Therapy
ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009).
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria) * aged 18-65 * working fluency in English * residence in the greater Philadelphia area.
Exclusion criteria
* Pervasive developmental disability * acute suicide potential * inability to travel to the treatment site * schizophrenia or other psychotic disorder * current substance dependence * Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale | baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks) | The SPAI social phobia assess symptoms of social anxiety in the presence of (a) strangers, (b) authority figures, (c) members of the opposite sex, and (d) people in general. The subscale ranges from 32 to 192, where higher scores reflect more severe symptoms of social anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcomes Questionnaire | baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks) | The Outcomes Questionnaire is a 45-item measure that assesses functioning and is comprised of three subscales: symptom distress, interpersonal relationships, and social role performance, that are combined to create a total score. Scores range from 45 to 180, where higher scores reflect greater levels of dysfunction. |
| Behavioral Assessment Test | baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks) | The assessment consists of two role-played interpersonal interactions and an impromptu speech. The role-plays were video recorded for subsequent rating by two independent assessors. Using a 5-point Likert scale (1 = poor and 5 = excellent), assessors rated global social skills, which were comprised of assessments of verbal content (e.g., amount of speech during task and degree to which speech was relevant and appropriate), nonverbal skills (e.g., degree of fidgeting and eye contact; appropriateness of gestures and posture), and paralinguistic skills (e.g., appropriateness of tone, enunciation, inflection, and rate). Prior research has employed this behavioral assessment protocol (Glassman et al., 2016; Herbert et al., 2005). These results reflect global social skills, which reflect the sum of ratings of verbal, nonverbal, and paralinguistic skills. Scores range from 3 to 15 with higher scores reflecting better social skills. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Therapy cognitive therapy and exposure
Cognitive Therapy: Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., if I attempt to initiate a conversation I'll humiliate myself), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005). | 40 |
| Acceptance and Committment Therapy acceptance and commitment therapy and exposure
Acceptance and Commitment Therapy: ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, & Emmelkamp, 2009). | 48 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 20 |
Baseline characteristics
| Characteristic | Acceptance and Committment Therapy | Total | Cognitive Therapy |
|---|---|---|---|
| Age, Continuous | 29.90 years STANDARD_DEVIATION 11.66 | 29.97 years STANDARD_DEVIATION 10.98 | 30.05 years STANDARD_DEVIATION 10.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 43 Participants | 22 Participants |
| Sex: Female, Male Female | 27 Participants | 45 Participants | 18 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 48 |
| other Total, other adverse events | 0 / 40 | 0 / 48 |
| serious Total, serious adverse events | 0 / 40 | 0 / 48 |
Outcome results
Primary
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
The SPAI social phobia assess symptoms of social anxiety in the presence of (a) strangers, (b) authority figures, (c) members of the opposite sex, and (d) people in general. The subscale ranges from 32 to 192, where higher scores reflect more severe symptoms of social anxiety.
Time frame: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy | Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale | Pre-Treatment | 131.66 units on a scale | Standard Deviation 19.63 |
| Cognitive Therapy | Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale | Post-Treatment | 75.47 units on a scale | Standard Deviation 27.99 |
| Acceptance and Committment Therapy | Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale | Pre-Treatment | 130.17 units on a scale | Standard Deviation 17.48 |
| Acceptance and Committment Therapy | Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale | Post-Treatment | 103.9 units on a scale | Standard Deviation 28.72 |
Secondary
Behavioral Assessment Test
The assessment consists of two role-played interpersonal interactions and an impromptu speech. The role-plays were video recorded for subsequent rating by two independent assessors. Using a 5-point Likert scale (1 = poor and 5 = excellent), assessors rated global social skills, which were comprised of assessments of verbal content (e.g., amount of speech during task and degree to which speech was relevant and appropriate), nonverbal skills (e.g., degree of fidgeting and eye contact; appropriateness of gestures and posture), and paralinguistic skills (e.g., appropriateness of tone, enunciation, inflection, and rate). Prior research has employed this behavioral assessment protocol (Glassman et al., 2016; Herbert et al., 2005). These results reflect global social skills, which reflect the sum of ratings of verbal, nonverbal, and paralinguistic skills. Scores range from 3 to 15 with higher scores reflecting better social skills.
Time frame: baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
Population: A subset of randomized participants (n = 12 for ACT and n = 11 for tCBT) completed this behavioral assessment task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy | Behavioral Assessment Test | Pre-Treatment | 9.12 units on a scale | Standard Deviation 2.02 |
| Cognitive Therapy | Behavioral Assessment Test | Post-Treatment | 10.2 units on a scale | Standard Deviation 2.16 |
| Acceptance and Committment Therapy | Behavioral Assessment Test | Pre-Treatment | 8.33 units on a scale | Standard Deviation 1.31 |
| Acceptance and Committment Therapy | Behavioral Assessment Test | Post-Treatment | 10.64 units on a scale | Standard Deviation 1.37 |
Secondary
Outcomes Questionnaire
The Outcomes Questionnaire is a 45-item measure that assesses functioning and is comprised of three subscales: symptom distress, interpersonal relationships, and social role performance, that are combined to create a total score. Scores range from 45 to 180, where higher scores reflect greater levels of dysfunction.
Time frame: baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Therapy | Outcomes Questionnaire | Pre-Treatment | 120.06 units on a scale | Standard Deviation 18.4 |
| Cognitive Therapy | Outcomes Questionnaire | Post-Treatment | 91.34 units on a scale | Standard Deviation 24.51 |
| Acceptance and Committment Therapy | Outcomes Questionnaire | Pre-Treatment | 118.36 units on a scale | Standard Deviation 25.21 |
| Acceptance and Committment Therapy | Outcomes Questionnaire | Post-Treatment | 105.54 units on a scale | Standard Deviation 24.39 |