Trial Outcomes & Findings for Interpretation Modification Program for Social Phobia (NCT NCT00684541)
NCT ID: NCT00684541
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
49 participants
Primary outcome timeframe
Pre, Post (6 weeks), Followup (3 months after post-assessment)
Results posted on
2014-05-01
Participant Flow
Participant milestones
| Measure |
Interpretation Modification Program (IMP)
The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard \& Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
|
Interpretation Control Condition (ICC)
The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
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|---|---|---|
|
Overall Study
STARTED
|
23
|
26
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interpretation Modification Program for Social Phobia
Baseline characteristics by cohort
| Measure |
Interpretation Modification Program
n=23 Participants
The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard \& Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
|
Interpretation Control Condition
n=26 Participants
The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
|
Total
n=49 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
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre, Post (6 weeks), Followup (3 months after post-assessment)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 |
Interpretation Modification Program
n=20 Participants
The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard \& Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
|
Interpretation Control Condition
n=23 Participants
The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
|
|---|---|---|
|
Liebowitz Social Anxiety Scale (LSAS)
follow-up
|
40.8 units on a scale
Standard Deviation 21.6
|
NA units on a scale
Standard Deviation NA
Data not collected for ICC at follow-up.
|
|
Liebowitz Social Anxiety Scale (LSAS)
pre-tx
|
82.0 units on a scale
Standard Deviation 18.4
|
77.7 units on a scale
Standard Deviation 18.6
|
|
Liebowitz Social Anxiety Scale (LSAS)
post
|
50.2 units on a scale
Standard Deviation 19.3
|
67.6 units on a scale
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Pre, Post (6 weeks), Followup (3 months after post-assessment)Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, \& Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.
Outcome measures
| Measure |
Interpretation Modification Program
n=23 Participants
The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard \& Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
|
Interpretation Control Condition
n=26 Participants
The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
|
|---|---|---|
|
Social Phobia and Agoraphobia Inventory
pre-tx
|
145.0 units on a scale
Standard Deviation 26.8
|
146.1 units on a scale
Standard Deviation 21.8
|
|
Social Phobia and Agoraphobia Inventory
post-tx
|
112.0 units on a scale
Standard Deviation 34.4
|
118.1 units on a scale
Standard Deviation 43.7
|
|
Social Phobia and Agoraphobia Inventory
follow-up
|
94.7 units on a scale
Standard Deviation 37.7
|
NA units on a scale
Standard Deviation NA
Data not collected from ICC group at follow-up
|
Adverse Events
Interpretation Modification Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interpretation Control Condition
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place