Trial Outcomes & Findings for Attention Disengagement Training for Social Phobia (NCT NCT00684320)
NCT ID: NCT00684320
Last Updated: 2014-05-01
Results Overview
Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Pre-Treatment, Post-Treatment (6 weeks)
Results posted on
2014-05-01
Participant Flow
Participant milestones
| Measure |
2 Placebo Condition (PC)
The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
|
1 Attention Disengagement Training (ADT)
Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
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|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attention Disengagement Training for Social Phobia
Baseline characteristics by cohort
| Measure |
2 Placebo Condition (PC)
n=26 Participants
The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
|
1 Attention Disengagement Training (ADT)
n=22 Participants
Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
male
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Sex/Gender, Customized
female
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Sex/Gender, Customized
unreported
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Treatment, Post-Treatment (6 weeks)Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms
Outcome measures
| Measure |
2 Placebo Condition (PC)
n=22 Participants
The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
|
1 Attention Disengagement Training (ADT)
n=22 Participants
Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
|
|---|---|---|
|
Liebowitz Social Anxiety Scale (LSAS)
Pre-Treatment
|
68.1 units on a scale
Standard Deviation 16.7
|
74.5 units on a scale
Standard Deviation 16.6
|
|
Liebowitz Social Anxiety Scale (LSAS)
Post-Treatment
|
60.0 units on a scale
Standard Deviation 18.2
|
46.1 units on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Pre-Treatment, Post-Treatment (after 4 weeks of treatment)Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, \& Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).
Outcome measures
| Measure |
2 Placebo Condition (PC)
n=22 Participants
The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.
Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe.
|
1 Attention Disengagement Training (ADT)
n=22 Participants
Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
|
|---|---|---|
|
Social Phobia and Anxiety Inventory
Pre-Treatment
|
126.7 units on a scale
Standard Deviation 20.9
|
132.3 units on a scale
Standard Deviation 17.3
|
|
Social Phobia and Anxiety Inventory
Post-Treatment
|
109.0 units on a scale
Standard Deviation 30.9
|
99.1 units on a scale
Standard Deviation 30.8
|
Adverse Events
2 Placebo Condition (PC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 Attention Disengagement Training (ADT)
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
Dr. Nader Amir
San Diego State University/University of California Joint Doctoral Program in Clinical Psychology
Phone: (619) 229-3740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place