Trial Outcomes & Findings for Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1) (NCT NCT01551199)

Results Overview

The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

1-week post-treatment (approximately week 14)

Results posted on

2017-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Multiple Channel Exosure Therapy (MCET-V) MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Overall Study STARTED	7
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multiple Channel Exposure Therapy (MCET) n=7 Participants MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Age, Continuous	37 years STANDARD_DEVIATION 6.9 • n=5 Participants
Gender Female	4 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Beck Anxiety Inventory	40.6 units on a scale STANDARD_DEVIATION 9.93 • n=5 Participants
Beck Depression Inventory	36.4 units on a scale STANDARD_DEVIATION 8.11 • n=5 Participants

PRIMARY outcome

Timeframe: 1-week post-treatment (approximately week 14)

The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

Outcome measures

Outcome measures
Measure	MCET-V n=2 Participants MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Clinician Administered PTSD Scale (CAPS)	29.5 units on a scale Standard Deviation 23.3

PRIMARY outcome

Timeframe: 3-month follow-up (approximately week 26)

The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

Outcome measures

Outcome measures
Measure	MCET-V n=2 Participants MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Clinician Administered PTSD Scale (CAPS)	17 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 3 Months

The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.

Outcome measures

Outcome measures
Measure	MCET-V n=2 Participants MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) Participants without panic disorder	100 percentage of participants
Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) Participants with panic disorder	0 percentage of participants

Adverse Events

Arm 1

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

Dr. Ellen Teng

Michael E. DeBakey VA Medical Center

Phone: (713) 791-1414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place