Quality of Research
Documents Reviewed
The documents below were reviewed for Quality of Research. The research point of
contact can provide information regarding the studies reviewed and the availability
of additional materials, including those from more recent studies that may have been conducted.
Study 1Barlow, D. H., Craske, M. G., Cerny, J. A., & Klosko, J. S. (1989). Behavioral treatment of panic disorder. Behavior Therapy, 20, 261-282.
Craske, M. G., Brown, T. A., & Barlow, D. H. (1991). Behavioral treatment of panic disorder: A two-year follow-up. Behavior Therapy, 22, 289-304. Study 2Klosko, J. S., Barlow, D. H., Tassinari, R., & Cerny, J. A. (1990). A comparison of alprazolam and behavior therapy in treatment of panic disorder. Journal of Consulting and Clinical Psychology, 58(1), 77-84.  Study 3Barlow, D. H., Gorman, J. M., Shear, M. K., & Woods, S. W. (2000). Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. Journal of the American Medical Association, 283(19), 2529-2536. 
Outcomes
| Outcome 1: Severity of panic disorder |
|
Description of Measures
|
In two studies, the following measures were used to assess the severity of panic disorder:
- Clinical severity rating--Clients' level of distress and disability was rated by trained interviewers using the Anxiety Disorder Interview Schedule—Revised (ADIS-R), a diagnostic instrument used to assess for current anxiety episodes and provide a differential diagnosis among anxiety disorders according to DSM-III-R criteria. Severity ratings were on a scale of 0 (no distress or disability) to 8 (very severely disturbing/disabling). A separate severity rating was obtained for the panic symptom dyspnea (shortness of breath).
- Number of panic attacks in the past month--During the ADIS-R interview, clients recalled how many panic attacks they had in the past month as well as the number and intensity of somatic and cognitive symptoms.
- Number of panic attacks in past 2 weeks--On daily self-monitoring forms, clients rated their current levels of anxiety, depression, and pleasantness on 0-8 (low to high) scales four times per day. For any episode rated 4 or higher, clients recorded the following information: time of episode onset/offset; maximum level of anxiety experienced (0-8); whether the episode was a panic attack (versus more generalized anxiety); the duration of the panic; and whether the episode was associated with a stressful event. Data from these forms were used to calculate the following for the 2-week period prior to assessment:
- Total number of panic attacks in past 2 weeks
- Average number of anxiety episodes per week
- Average number of panic attacks per week
- Average intensity of anxiety and panic episodes
- Average daily ratings of anxiety, depression, and pleasantness
In a third study, severity was rated by trained interviewers using the Panic Disorder Severity Scale (PDSS), a scripted interview consisting of 7 items, each rated on a 0-4 scale. Items assess panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning. Total PDSS scores range from 0 to 28, with higher scores indicating greater severity of disorder.
|
|
Key Findings
|
In one study, PCT was compared with relaxation therapy, PCT plus relaxation therapy, and wait-list control. Assessments were completed at baseline and posttest (all study groups) and 6 and 24 months after posttest (active treatment groups only). Findings included the following:
- From baseline to posttest, clinical severity ratings differed significantly across the four study groups (p < .001). All three active treatment groups showed greater improvement in clinical severity ratings from baseline to posttest compared with the wait-list group (p values < .0001).
- At posttest, the PCT-only group and PCT plus relaxation group had higher proportions of clients with zero panic attacks in the past 2 weeks compared with the wait-list group (p values < .05).
- At 6-month follow-up, the PCT-only group and PCT plus relaxation group had higher proportions of clients reporting zero panic attacks in the past month compared with the relaxation-only group (p values < .05). There were no significant between-group differences in the proportion of clients reporting zero panic attacks at the 24-month follow-up.
In a second study, PCT was compared with alprazolam (a benzodiazepine), pill placebo, and wait-list control. Assessments were completed at baseline and posttest. Findings included the following (all results controlling for baseline values):
- At posttest, the PCT group and alprazolam group showed greater improvement in clinical severity ratings compared with the wait-list group (p < .01).
- At posttest, the PCT group showed a greater reduction in the number of panic symptoms endorsed in the ADIS-R interview and in the severity of cognitive and somatic symptoms compared with the wait-list group (p values < .05).
- At posttest, the PCT group showed greater improvement in the severity of dyspnea compared with the alprazolam and wait-list groups (p < .05).
- At posttest, the PCT group had a higher proportion of clients with zero panic attacks in the past 2 weeks compared with the placebo (p < .05) and wait-list (p < .01) groups.
In a third study, PCT was compared with imipramine (a tricyclic antidepressant) plus medical management, pill placebo plus medical management, PCT plus imipramine, and PCT plus placebo. Assessments were completed at baseline, after 3 months of weekly treatment (acute phase posttest), after 6 months of monthly treatment (maintenance phase posttest), and 15 months after baseline. Intent-to-treat analyses were conducted. Findings included the following:
- At the acute phase posttest, the PCT-only group (p = .02) and imipramine-only group (p = .009) had lower severity scores on the Panic Disorder Severity Scale compared with the placebo group. The combination of PCT and imipramine produced lower severity scores than PCT alone (p = .02).
- At the maintenance phase posttest, the PCT-only group (p = .05) and imipramine-only group (p = .04) had lower severity scores compared with the placebo group. The combination of PCT and imipramine produced lower severity scores than PCT alone (p = .004), imipramine alone (p = .01), and PCT plus placebo (p = .04).
- At 15-month follow-up, compared with the placebo group, the PCT-only group had a higher proportion of clients demonstrating a 40% reduction in severity scores from baseline (p = .05).
|
|
Studies Measuring Outcome
|
Study 1, Study 2, Study 3
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
2.8
(0.0-4.0 scale)
|
| Outcome 2: Anxiety symptoms |
|
Description of Measures
|
The Hamilton Anxiety Scale (HAM-A) was used to assess the severity of clients' anxiety symptoms. The HAM-A consists of 14 questions, each associated with a symptom of anxiety. Each symptom is rated on a 5-point scale from 0 (not present) to 4 (severe).
|
|
Key Findings
|
In one study, PCT was compared with relaxation therapy, PCT plus relaxation therapy, and wait-list control. Assessments were completed at baseline and posttest (all study groups) and 6 and 24 months after posttest (active treatment groups only). Findings included the following:
- From baseline to posttest, all three active treatment groups demonstrated greater improvement in anxiety symptoms compared with the wait-list group (p < .01).
- From posttest to 6-month follow-up, the PCT-only group and PCT plus relaxation group maintained treatment gains while anxiety symptoms worsened among clients receiving relaxation therapy only (p < .02).
In a second study, PCT was compared with alprazolam (a benzodiazepine), pill placebo, and wait-list control. Assessments were completed at baseline and posttest. Findings included the following:
- From baseline to posttest, the PCT group showed greater improvement in anxiety symptoms compared with the wait-list group (p < .05).
|
|
Studies Measuring Outcome
|
Study 1, Study 2
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
2.9
(0.0-4.0 scale)
|
| Outcome 3: Depression symptoms |
|
Description of Measures
|
Depression symptoms were measured using the Beck Depression Inventory (BDI), a 21-item self-report instrument. Scores range from 0 to 63, with higher scores indicating more severe symptoms. Items correspond to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, and physical symptoms such as fatigue and weight loss.
|
|
Key Findings
|
In one study, PCT was compared with relaxation therapy, PCT plus relaxation therapy, and wait-list control. Assessments were completed at baseline and posttest (all study groups) and 6 and 24 months after posttest (active treatment groups only). Findings included the following:
- From posttest to 24-month follow-up, the change in depression symptoms was significantly different between the PCT-only and relaxation-only groups (p < .05), with depression symptoms decreasing in the PCT group and increasing in the relaxation group.
|
|
Studies Measuring Outcome
|
Study 1
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
2.8
(0.0-4.0 scale)
|
| Outcome 4: Treatment response |
|
Description of Measures
|
In one study, clients' response to treatment (i.e., whether they showed meaningful improvement) was determined using a composite set of criteria. A client was considered to be a treatment responder if an improvement of 20% or greater occurred for at least three of the following measures:
- Clinical severity rating--Clients' level of distress and disability was rated by trained interviewers using the Anxiety Disorder Interview Schedule—Revised (ADIS-R), a diagnostic instrument used to assess for current anxiety episodes and provide a differential diagnosis among anxiety disorders according to DSM-III-R criteria. Severity ratings were on a scale of 0 (no distress or disability) to 8 (very severely disturbing/disabling).
- Fear Questionnaire rating--This instrument is a self-report measure of phobic distress with ratings given on a scale of 0-8, with 8 representing greatest distress.
- Average number of panic attacks per week--On daily self-monitoring forms, clients rated their current levels of anxiety, depression, and pleasantness on 0-8 (low to high) scales four times per day. For any episode rated 4 or higher, clients recorded the following information: time of episode onset/offset; maximum level of anxiety experienced on a 0-8 (low to high) scale; whether the episode was a panic attack (versus more generalized anxiety); the duration of the panic; and whether the episode was associated with a stressful event. Data from these forms were used to calculate the following for the 2-week period prior to assessment:
- Total number of panic attacks in past 2 weeks
- Average number of anxiety episodes per week
- Average number of panic attacks per week
- Average intensity of anxiety and panic episodes
- Average daily ratings of anxiety, depression, and pleasantness
- Subjective Symptom Scale total score--This instrument measures the interference of anxiety in 5 areas of daily functioning (e.g., work, leisure, home management), each area rated on a 0-8 scale for a total score ranging from 0 to 40.
In another study, treatment response was determined at posttest and follow-up using the Clinical Global Impression--Severity (CGI-S) and Clinical Global Impression--Improvement (CGI-I) scales. The CGI-S requires the interviewer to rate the severity of the client's disorder on a 1-7 scale (ranging from normal/not at all ill to extremely ill), based on the interviewer's past experience with clients with the same diagnosis. For the CGI-I, the interviewer assesses the client's level of improvement or deterioration from baseline on a 1-7 scale (ranging from very much improved to very much worse). Clients were classified as treatment responders if they attained a CGI improvement rating of 2 (much improved) or higher and had a CGI severity rating not exceeding 3 (mildly ill).
|
|
Key Findings
|
In one study, PCT was compared with relaxation therapy, PCT plus relaxation therapy, and wait-list control. Assessments were completed at baseline and posttest (all study groups) and 6 and 24 months after posttest (active treatment groups only).
- At posttest, all three active treatment groups had a higher proportion of treatment responders compared with the wait-list group (PCT: p < .05; relaxation: p < .01; PCT plus relaxation: p < .05). There were no significant differences among the active treatment groups.
In another study, PCT was compared with imipramine (a tricyclic antidepressant) with medical management, pill placebo with medical management, PCT plus imipramine, and PCT plus placebo. Assessments were completed after 3 months of weekly treatment (acute phase posttest), after 6 months of monthly treatment (maintenance phase posttest), and 15 months after baseline. Intent-to-treat analyses were conducted. Findings included the following:
- At the maintenance phase posttest, clients in the PCT-only (p = .01) and imipramine-only (p = .02) groups had a higher likelihood of being a treatment responder than those receiving placebo. The combination of PCT and imipramine was superior to imipramine alone in maximizing treatment response (p = .03).
|
|
Studies Measuring Outcome
|
Study 1, Study 3
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
2.8
(0.0-4.0 scale)
|
| Outcome 5: End-state functioning |
|
Description of Measures
|
End-state functioning refers to a client's overall level of functioning after participating in treatment. In one study, this outcome was applied only to clients classified as treatment responders. Clients were considered to have high end-state functioning at posttest if they met at least three of the following criteria:
- Clinical severity rating--Clients' level of distress and disability was rated by trained interviewers using the Anxiety Disorder Interview Schedule—Revised (ADIS-R), a diagnostic instrument used to assess for current anxiety episodes and provide a differential diagnosis among anxiety disorders according to DSM-III-R criteria. Severity ratings were on a scale of 0 (no distress or disability) to 8 (very severely disturbing/disabling).
- Fear Questionnaire rating of 2 or lower--This instrument is a self-report measure of phobic distress with ratings given on a 0-8 scale, with 8 representing greatest distress.
- Zero panic attacks per week--On daily self-monitoring forms, clients rated their current levels of anxiety, depression, and pleasantness on 0-8 (low to high) scales four times per day. For any episode rated 4 or higher, clients recorded the following information: time of episode onset/offset; maximum level of anxiety experienced on a 0-8 (low to high) scale; whether the episode was a panic attack (versus more generalized anxiety); the duration of the panic; and whether the episode was associated with a stressful event. Data from these forms were used to calculate the following for the 2-week period prior to assessment:
- Total number of panic attacks
- Average number of anxiety episodes per week
- Average number of panic attacks per week
- Average intensity of anxiety and panic episodes
- Average daily ratings of anxiety, depression, and pleasantness
- Anxiety self-rating of 2 or lower, derived from the self-monitoring records described above.
- Subjective Symptom Scale score of 10 or lower--This instrument measures the interference of anxiety in 5 areas of daily functioning, such as work, leisure, and home management, each area rated on a 0-8 scale for a total score of 0-40.
At follow-up assessments, high end-state functioning was achieved if clients met two criteria (both from the ADIS-R interview):
- Clinical severity rating of 2 or lower; and
- Zero panic attacks in the past month.
In another study, this outcome was limited to study completers. Clients were classified as having high end-state functioning if they had a clinical severity rating (from the ADIS-R interview) of less than 4 at posttest.
|
|
Key Findings
|
In one study, PCT was compared with relaxation therapy, PCT plus relaxation therapy, and wait-list control. Assessments were completed at baseline and posttest (all study groups) and 6 and 24 months after posttest (active treatment groups only). Findings included the following:
- At posttest, all three active treatment groups had a higher proportion of clients with high end-state functioning compared with the wait-list group (PCT: p < .05; relaxation: p < .05; PCT plus relaxation: p < .05). The proportions did not differ significantly among the active treatment groups.
- At 6-month follow-up, the PCT-only group and PCT plus relaxation group both had a higher proportion of clients with high end-state functioning compared with the relaxation-only group (p < .05). There were no significant between-group differences in the proportion of clients with high end-state functioning at the 24-month follow-up.
In a second study, PCT was compared with alprazolam (a benzodiazepine), pill placebo, and wait-list control. Assessments were completed at baseline and posttest. Findings from this study included the following:
- At posttest, the PCT group had a higher proportion of clients with high end-state functioning compared with the wait-list group (p < .01).
|
|
Studies Measuring Outcome
|
Study 1, Study 2
|
|
Study Designs
|
Experimental
|
|
Quality of Research Rating
|
2.5
(0.0-4.0 scale)
|
Study Populations
The following populations were identified in the studies reviewed for Quality of
Research.
|
Study
|
Age
|
Gender
|
Race/Ethnicity
|
|
Study 1
|
18-25 (Young adult) 26-55 (Adult) 55+ (Older adult)
|
76.8% Male 23.2% Female
|
100% Race/ethnicity unspecified
|
|
Study 2
|
18-25 (Young adult) 26-55 (Adult) 55+ (Older adult)
|
73.7% Female 26.3% Male
|
100% White
|
|
Study 3
|
18-25 (Young adult) 26-55 (Adult) 55+ (Older adult)
|
62.5% Female 37.5% Male
|
90.8% White 9.2% Race/ethnicity unspecified
|
Quality of Research Ratings by Criteria (0.0-4.0 scale)
External reviewers independently evaluate the Quality of Research for an intervention's
reported results using six criteria:
For more information about these criteria and the meaning of the ratings, see Quality of Research.
|
Outcome
|
Reliability
of Measures
|
Validity
of Measures
|
Fidelity
|
Missing
Data/Attrition
|
Confounding
Variables
|
Data
Analysis
|
Overall
Rating
|
|
1: Severity of panic disorder
|
3.3
|
3.3
|
2.8
|
1.9
|
2.3
|
3.0
|
2.8
|
|
2: Anxiety symptoms
|
4.0
|
4.0
|
2.8
|
1.4
|
2.3
|
3.0
|
2.9
|
|
3: Depression symptoms
|
4.0
|
4.0
|
2.8
|
1.3
|
2.0
|
3.0
|
2.8
|
|
4: Treatment response
|
3.4
|
3.6
|
2.8
|
1.6
|
2.3
|
2.9
|
2.8
|
|
5: End-state functioning
|
2.9
|
2.9
|
2.8
|
1.6
|
2.3
|
2.8
|
2.5
|
Study Strengths Many of the measures used in the studies are widely known with strong psychometric properties. Interrater agreement was examined for some of the measures in the studies and was found to be high. Fidelity was maximized through extensive training of therapists, use of a detailed manual, and weekly supervision, and samples of audiotaped sessions were rated for treatment adherence and competence. Fidelity ratings were high and comparable across the active treatment conditions. In all three studies, similarity was demonstrated between retained participants and those lost to attrition. Baseline differences between study groups were minimal, and interviewers were blind to treatment condition. Most statistical analyses were appropriate, with correction made for multiple comparisons.
Study Weaknesses No psychometric data were presented for the fidelity measurement tool. Attrition and missing data levels were generally high across studies and differed across conditions. There were a few confounds across studies. The appropriateness of the intent-to-treat analysis in the third study is questionable given the level and differential rates of attrition. In two studies, the sample size may have been too small to detect some effects.
|
|