Trial Outcomes & Findings for Comparison of Psychotherapy Programs to Treat Panic Disorder (NCT NCT00353470)
NCT ID: NCT00353470
Last Updated: 2022-12-23
Results Overview
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
201 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-12-23
Participant Flow
Participant milestones
| Measure |
PFPP
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
39
|
|
Overall Study
COMPLETED
|
61
|
61
|
23
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Psychotherapy Programs to Treat Panic Disorder
Baseline characteristics by cohort
| Measure |
PFPP
n=81 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=81 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=39 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
Total
n=201 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
36 years
STANDARD_DEVIATION 12 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
81 participants
n=7 Participants
|
39 participants
n=5 Participants
|
201 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: one subject was eliminated from analyses with DSMB consent as they lied about symptoms at intake and did not meet inclusion criteria
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
Outcome measures
| Measure |
PFPP
n=80 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=81 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=39 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Panic Disorder Severity Scale
|
6.72 score on a scale
Standard Deviation 4.49
|
5.78 score on a scale
Standard Deviation 3.48
|
7 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Outcome measures
| Measure |
PFPP
n=78 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=79 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=38 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Sheehan Disability Scale
|
6.4 score on a scale
Standard Deviation 6.74
|
6.28 score on a scale
Standard Deviation 5.89
|
6.9 score on a scale
Standard Deviation 4.43
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Outcome measures
| Measure |
PFPP
n=79 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=77 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=38 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Clinical Global Impressions Scale
|
2.17 units on a scale
Standard Deviation 1.28
|
2.16 units on a scale
Standard Deviation 0.90
|
2.38 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Outcome measures
| Measure |
PFPP
n=79 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=81 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=39 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale
|
11.37 units on a scale
Interval 0.0 to 81.0
|
10.18 units on a scale
Interval 0.0 to 81.0
|
11.55 units on a scale
Interval 0.0 to 81.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
level of state anxiety. 0=symptom free, 56 most severe
Outcome measures
| Measure |
PFPP
n=79 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=81 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=39 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Hamilton Anxiety Rating Scale
|
7.97 units on a scale
Standard Deviation 6.13
|
7.87 units on a scale
Standard Deviation 5.89
|
6.30 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety
Outcome measures
| Measure |
PFPP
n=79 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=77 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=38 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Anxiety Disorder Sensitivity Index
|
27.07 score on a scale
Standard Deviation 12.77
|
17.71 score on a scale
Standard Deviation 9.87
|
19.09 score on a scale
Standard Deviation 12.28
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
The BBSIQ measures how physically sensitive the person is to physical symptoms of anxiety; (scores range 0-63) 0= no anxiety; 63= highest levels of physical anxiety
Outcome measures
| Measure |
PFPP
n=73 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=79 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=37 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)
|
1.80 score on a scale
Standard Deviation 0.39
|
1.62 score on a scale
Standard Deviation 0.31
|
1.70 score on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data is presented for those subjects from whom data was collected for this measure.
Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
Outcome measures
| Measure |
PFPP
n=79 Participants
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=78 Participants
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=38 Participants
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Panic-Specific Reflective Function
|
4.67 units on a scale
Standard Deviation 1.11
|
3.67 units on a scale
Standard Deviation 1.15
|
3.20 units on a scale
Standard Deviation 1.03
|
Adverse Events
PFPP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C.B.T.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A.R.T.
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PFPP
n=81 participants at risk
Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
Panic focused psychodynamic psychotherapy (PFPP): PFPP will include 19 to 24 sessions over 12 weeks.
|
C.B.T.
n=81 participants at risk
Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Cognitive behavioral therapy: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.
|
A.R.T.
n=39 participants at risk
Participants will receive applied relaxation training for 12 weeks
Applied relaxation training (ART): ART with exposure protocol will include 19 to 24 sessions over 12 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
hospitalization
|
0.00%
0/81 • Subjects assessed for AEs for three months of therapy, 3 months of crossover (if eligible) and 12 months of follow-up; 15-18 months
|
0.00%
0/81 • Subjects assessed for AEs for three months of therapy, 3 months of crossover (if eligible) and 12 months of follow-up; 15-18 months
|
100.0%
2/2 • Number of events 2 • Subjects assessed for AEs for three months of therapy, 3 months of crossover (if eligible) and 12 months of follow-up; 15-18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Barbara Milrod, M.D., PI
Albert Einstein College of Medicine
Phone: 212-595-0806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place