Trial Outcomes & Findings for Adaptive Disclosure: A Combat-Specific PTSD Treatment (NCT NCT01628718)

Last Updated: 2020-04-09

Results Overview

Proportion of patients recovered (meets Reliable Change Index (RCI) threshold and has change of at least 2SD from baseline to post-treatment), improved (meets positive RCI threshold), unchanged (does not meet RCI threshold) or deteriorated (meets negative RCI threshold) based on change in the CAPS-IV.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

Pre-treatment (baseline), post-treatment (8-12 weeks)

Results posted on

2020-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	CPT-C Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.	Adaptive Disclosure (AD) Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
Overall Study STARTED	60	62
Overall Study COMPLETED	33	37
Overall Study NOT COMPLETED	27	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adaptive Disclosure: A Combat-Specific PTSD Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPT-C n=60 Participants Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.	Adaptive Disclosure (AD) n=62 Participants Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.	Total n=122 Participants Total of all reporting groups
Age, Continuous	29.29 years STANDARD_DEVIATION 6.38 • n=5 Participants	30.30 years STANDARD_DEVIATION 6.43 • n=7 Participants	29.80 years STANDARD_DEVIATION 6.39 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	56 Participants n=7 Participants	110 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Other Race/Ethnicity	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	62 participants n=7 Participants	122 participants n=5 Participants
PTSD severity as measured by the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)	76.53 units on a scale STANDARD_DEVIATION 18.43 • n=5 Participants	74.58 units on a scale STANDARD_DEVIATION 19.25 • n=7 Participants	75.54 units on a scale STANDARD_DEVIATION 18.80 • n=5 Participants
PTSD severity as measures by the PTSD Checklist, military version (PCL-M)	62.47 units on a scale STANDARD_DEVIATION 11.06 • n=5 Participants	63.00 units on a scale STANDARD_DEVIATION 11.45 • n=7 Participants	62.74 units on a scale STANDARD_DEVIATION 11.22 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment (baseline), post-treatment (8-12 weeks)

Population: Intent to treat

Outcome measures

Outcome measures
Measure	CPT-C n=60 Participants Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.	Adaptive Disclosure (AD) n=62 Participants Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) Recovered	8 Participants	11 Participants
Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) Improved	7 Participants	4 Participants
Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) Unchanged	45 Participants	47 Participants
Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) Deteriorated	0 Participants	0 Participants

Adverse Events

CPT-C

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Adaptive Disclosure (AD)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CPT-C n=60 participants at risk Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.	Adaptive Disclosure (AD) n=62 participants at risk Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
Psychiatric disorders Alcohol poisoning	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	0.00% 0/62 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Psychiatric disorders Dissociative episode	0.00% 0/60 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	1.6% 1/62 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Psychiatric disorders Suicide attempt	0.00% 0/60 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	1.6% 1/62 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.

Other adverse events

Other adverse events
Measure	CPT-C n=60 participants at risk Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. Cognitive Processing Therapy, cognitive version only (CPT-C): Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.	Adaptive Disclosure (AD) n=62 participants at risk Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. Adaptive Disclosure (AD): Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor	0.00% 0/60 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	1.6% 1/62 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Gastrointestinal disorders Upset stomach	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	0.00% 0/62 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Nervous system disorders Lightheadedness	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	0.00% 0/62 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Renal and urinary disorders Urinary tract infection	0.00% 0/60 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	1.6% 1/62 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Psychiatric disorders Increased psychiatric symptoms	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	8.1% 5/62 • Number of events 5 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Psychiatric disorders Suicidal ideation	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	3.2% 2/62 • Number of events 2 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Nervous system disorders Migraine	1.7% 1/60 • Number of events 1 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	3.2% 2/62 • Number of events 2 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
Skin and subcutaneous tissue disorders Allergic reaction	3.3% 2/60 • Number of events 2 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.	0.00% 0/62 • Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.

Additional Information

Brett T. Litz, PhD

Massachusetts Veterans Epidemiological Research and Information Center

Phone: 617-584-9314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place