Trial Outcomes & Findings for Social Phobia Intervention Study of Mannheim (NCT NCT00434759)
NCT ID: NCT00434759
Last Updated: 2012-11-28
Results Overview
This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.
COMPLETED
NA
89 participants
baseline to post-treatment (on average 24 weeks)
2012-11-28
Participant Flow
Participant milestones
| Measure |
Stepped Care Program
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
|
Standardtherapy
standard therapy (therapist-guided intervention only)
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
43
|
|
Overall Study
COMPLETED
|
22
|
38
|
|
Overall Study
NOT COMPLETED
|
24
|
5
|
Reasons for withdrawal
| Measure |
Stepped Care Program
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
|
Standardtherapy
standard therapy (therapist-guided intervention only)
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
17
|
1
|
|
Overall Study
family affairs
|
2
|
0
|
Baseline Characteristics
Social Phobia Intervention Study of Mannheim
Baseline characteristics by cohort
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only)
|
Total
n=89 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
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.26 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
38.47 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
37.84 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
46 participants
n=5 Participants
|
43 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to post-treatment (on average 24 weeks)Population: Intention-to-Treat
This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.
Outcome measures
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only; 16 sessions)
|
|---|---|---|
|
Change From Baseline in Social Interaction Anxiety Scale (SIAS)
baseline
|
43.13 units on a scale
Standard Deviation 14.26
|
48.94 units on a scale
Standard Deviation 11.00
|
|
Change From Baseline in Social Interaction Anxiety Scale (SIAS)
post-treatment
|
34.85 units on a scale
Standard Deviation 14.86
|
33.35 units on a scale
Standard Deviation 16.90
|
PRIMARY outcome
Timeframe: baseline to post-treatment (on average 24 weeks)Population: Intention-to-Treat
The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.
Outcome measures
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only; 16 sessions)
|
|---|---|---|
|
Change From Baseline in Social Phobia Scale (SPS)
baseline
|
35.85 units on a scale
Standard Deviation 14.97
|
33.95 units on a scale
Standard Deviation 13.12
|
|
Change From Baseline in Social Phobia Scale (SPS)
post-treatment
|
24.89 units on a scale
Standard Deviation 17.41
|
17.58 units on a scale
Standard Deviation 13.36
|
PRIMARY outcome
Timeframe: baseline to post-treatment (on average 24 weeks)Population: Intention-to-Treat
The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.
Outcome measures
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only; 16 sessions)
|
|---|---|---|
|
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)
baseline
|
57.46 units on a scale
Standard Deviation 23.61
|
60.58 units on a scale
Standard Deviation 19.37
|
|
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)
post-treatment
|
41.22 units on a scale
Standard Deviation 23.49
|
31.84 units on a scale
Standard Deviation 21.57
|
SECONDARY outcome
Timeframe: baseline to post-treatment (on average 24 weeks)Population: Intention-to-Treat
The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.
Outcome measures
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only; 16 sessions)
|
|---|---|---|
|
Change From Baseline in Brief Symptom Inventory (BSI)
baseline
|
1.00 units on a scale
Standard Deviation 0.59
|
0.90 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline in Brief Symptom Inventory (BSI)
post-treatment
|
0.71 units on a scale
Standard Deviation 0.51
|
0.51 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: baseline to post-treatment (on average 24 weeks)Population: Intention-to-Treat
The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.
Outcome measures
| Measure |
Stepped Care Program
n=46 Participants
stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
|
Standardtherapy
n=43 Participants
standard therapy (therapist-guided intervention only; 16 sessions)
|
|---|---|---|
|
Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
baseline
|
21.48 units on a scale
Standard Deviation 9.97
|
21.47 units on a scale
Standard Deviation 11.04
|
|
Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
post-treatment
|
16.20 units on a scale
Standard Deviation 10.26
|
14.28 units on a scale
Standard Deviation 9.93
|
Adverse Events
Stepped Care Program
Standardtherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Martin Bohus
Central Institute of Mental Health, Mannheim, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place