Trial Outcomes & Findings for Variations of Cognitive Behavior Therapy for Social Anxiety Disorder (NCT NCT00948974)

Last Updated: 2018-10-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)

Results posted on

2018-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	40	48
Overall Study COMPLETED	17	28
Overall Study NOT COMPLETED	23	20

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Lost to Follow-up	23	20

Baseline Characteristics

Variations of Cognitive Behavior Therapy for Social Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Therapy n=40 Participants 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).	Acceptance and Committment Therapy n=48 Participants 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).	Total n=88 Participants Total of all reporting groups
Age, Continuous	30.05 years STANDARD_DEVIATION 10.25 • n=5 Participants	29.90 years STANDARD_DEVIATION 11.66 • n=7 Participants	29.97 years STANDARD_DEVIATION 10.98 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)

Outcome measures

Outcome measures
Measure	Cognitive Therapy n=17 Participants 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).	Acceptance and Committment Therapy n=28 Participants 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).
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale Pre-Treatment	131.66 units on a scale Standard Deviation 19.63	130.17 units on a scale Standard Deviation 17.48
Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale Post-Treatment	75.47 units on a scale Standard Deviation 27.99	103.9 units on a scale Standard Deviation 28.72

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive Therapy n=17 Participants 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).	Acceptance and Committment Therapy n=28 Participants 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).
Outcomes Questionnaire Pre-Treatment	120.06 units on a scale Standard Deviation 18.4	118.36 units on a scale Standard Deviation 25.21
Outcomes Questionnaire Post-Treatment	91.34 units on a scale Standard Deviation 24.51	105.54 units on a scale Standard Deviation 24.39

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cognitive Therapy n=11 Participants 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).	Acceptance and Committment Therapy n=12 Participants 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).
Behavioral Assessment Test Pre-Treatment	9.12 units on a scale Standard Deviation 2.02	8.33 units on a scale Standard Deviation 1.31
Behavioral Assessment Test Post-Treatment	10.2 units on a scale Standard Deviation 2.16	10.64 units on a scale Standard Deviation 1.37

Adverse Events

Cognitive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acceptance and Committment Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Evan Forman

Drexel University

Phone: 215.553.7113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place