Comparison of Psychotherapy Programs to Treat Panic Disorder

Dynamic Treatment vs. CBT for Panic Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353470

Enrollment

201

Registered

2006-07-18

Start date

2006-09-30

Completion date

2012-09-30

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agoraphobia, Anxiety Disorders, Panic Disorder

Keywords

PD, CBT, PFPP

Brief summary

This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.

Detailed description

Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD. Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.

Interventions

BEHAVIORALCognitive behavioral therapy

CBT for panic disorder will include 19 to 24 sessions over 12 weeks.

BEHAVIORALApplied relaxation training (ART)

ART with exposure protocol will include 19 to 24 sessions over 12 weeks.

BEHAVIORALPanic focused psychodynamic psychotherapy (PFPP)

PFPP will include 19 to 24 sessions over 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia * History of at least one spontaneous panic attack per week within the month prior to study entry

Exclusion criteria

* Active substance dependence within 6 months prior to study entry * Lifetime history of any psychotic disorder, including bipolar disorder * Acutely suicidal

Design outcomes

Primary

Measure	Time frame	Description
Panic Disorder Severity Scale	12 weeks	A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Secondary

Measure	Time frame	Description
Clinical Global Impressions Scale	12 weeks	Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Hamilton Depression Rating Scale	12 weeks	Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Hamilton Anxiety Rating Scale	12 weeks	level of state anxiety. 0=symptom free, 56 most severe
Sheehan Disability Scale	12 weeks	Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)	12 weeks	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
Panic-Specific Reflective Function	12 weeks	Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
Anxiety Disorder Sensitivity Index	12 weeks	Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	81
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.	81
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.	39
Total	201

Baseline characteristics

Characteristic	C.B.T.	A.R.T.	PFPP	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	81 Participants	39 Participants	81 Participants	201 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 12.9	36 years STANDARD_DEVIATION 12	39.8 years STANDARD_DEVIATION 13.2	38.8 years STANDARD_DEVIATION 13.2
Region of Enrollment United States	81 participants	39 participants	81 participants	201 participants
Sex: Female, Male Female	46 Participants	32 Participants	58 Participants	136 Participants
Sex: Female, Male Male	35 Participants	7 Participants	23 Participants	65 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 81	0 / 81	0 / 39
other Total, other adverse events	0 / 81	0 / 81	0 / 39
serious Total, serious adverse events	0 / 81	0 / 81	2 / 39

Outcome results

Primary

Panic Disorder Severity Scale

A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Time frame: 12 weeks

Population: one subject was eliminated from analyses with DSMB consent as they lied about symptoms at intake and did not meet inclusion criteria

Arm	Measure	Value (MEAN)	Dispersion
PFPP	Panic Disorder Severity Scale	6.72 score on a scale	Standard Deviation 4.49
C.B.T.	Panic Disorder Severity Scale	5.78 score on a scale	Standard Deviation 3.48
A.R.T.	Panic Disorder Severity Scale	7 score on a scale	Standard Deviation 2.94

Comparison: Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.p-value: >0.16Chi-squared

p-value: <0.05Mixed Models Analysis

Secondary

Anxiety Disorder Sensitivity Index

Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety

Time frame: 12 weeks