Social Anxiety DisorderNCT00948974
Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
A study testing Cognitive Therapy and Acceptance and Commitment Therapy in people with Social Anxiety Disorder, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Therapy and Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Therapy, Acceptance and Commitment Therapy
- Keywords
- social anxiety, treatment, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Cognitive Therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Also called CT
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).
Acceptance and Commitment TherapyBehavioural
Also called ACT
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).
| Study group | Role | What they receive |
|---|---|---|
| cognitive therapy | Active comparator | cognitive therapy and exposure Receives: Behavioral: Cognitive Therapy |
| acceptance and committment therapy | Active comparator | acceptance and commitment therapy and exposure Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
Secondary outcomes (2)
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.
Measured: baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
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.
Measured: baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Herbert, Drexel University
- Investigators
- James D. Herbert, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948974
- Sponsor's protocol ID
- 18345
- Status last verified
- Dec 2017
- First submitted
- 29 Jul 2009
- Last updated
- 5 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00948974
- Acronym / sponsor ID
- 18345
- Conditions
- Social Anxiety Disorder
- Keywords
- social anxiety, treatment, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Posted 5 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive therapy | Active comparator | Behavioral: Cognitive Therapycognitive therapy and exposure |
| acceptance and committment therapy | Active comparator | Behavioral: Acceptance and Commitment Therapyacceptance and commitment therapy and exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Pervasive developmental disability
- acute suicide potential
- inability to travel to the treatment site
- schizophrenia or other psychotic disorder
- current substance dependence
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 |
|---|---|---|
| Cognitive TherapyAlso: CTCognitive 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). | Behavioural | cognitive therapy |
| Acceptance and Commitment TherapyAlso: ACTACT 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). | Behavioural | acceptance and committment therapy |
Primary outcome
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
Time frame: 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.
2 secondary outcomes
Outcomes Questionnaire
Time frame: baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
Behavioral Assessment Test
Time frame: baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
James D. Herbert, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy and Acceptance and Commitment Therapy in people with Social Anxiety Disorder, run by Drexel University at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 5 Oct 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale (time frame: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2018.