Trial Outcomes & Findings for Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD (NCT NCT03702166)
NCT ID: NCT03702166
Last Updated: 2021-05-26
Results Overview
The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total scores range from 0-80 with a lower score indicating less symptoms of PTSD. Subscales were not utilized in analyses.
COMPLETED
NA
10 participants
Baseline and Week 15
2021-05-26
Participant Flow
Participant milestones
| Measure |
Interventional CPT
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Interventional CPT
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Baseline characteristics by cohort
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
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Age, Continuous
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45.3 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 15Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total scores range from 0-80 with a lower score indicating less symptoms of PTSD. Subscales were not utilized in analyses.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
Pre-treatment at baseline
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33.10 score on a scale
Standard Deviation 7.50
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Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
Post-treatment at 15 weeks
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16.13 score on a scale
Standard Deviation 14.49
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PRIMARY outcome
Timeframe: Baseline and Week 15Population: Baseline at pre-treatment included 10 subjects, post-treatment included only 8 subjects who completed the study.
The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past month (for baseline and follow up assessments) as a result of a specific life event. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely). Possible total score range is 0-80, with a lower score indicating less PTSD symptoms. Subscales were not utilized in analyses.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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|---|---|
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Change in Score on the PTSD Check List-5 (PCL-5)
Pre-treatment at baseline
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42.7 score on a scale
Standard Deviation 12.25
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Change in Score on the PTSD Check List-5 (PCL-5)
Post-treatment at 15 weeks
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17.75 score on a scale
Standard Deviation 18.91
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PRIMARY outcome
Timeframe: Baseline and Week 15Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
The TFI has 25 items that are used to calculate eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress related to tinnitus. The same 25 items are used to calculate the total score, which was used for the purpose of this study. For the total score, the 25 scale items are scored 0-10 (those scored as a percentage are converted to a score of 1-10). Scores are totaled giving a potential range of 0-250 with a higher score indicating that tinnitus interferes more with the subject. The total score is then divided by the number of questions answered to give a mean score. The mean score is multiplied by 10 to provide an overall TFI score within a 0-100 range, where a lower score indicates that the tinnitus does not interfere with the subjects well-being as much.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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Change in Score on the Tinnitus Functional Index (TFI)
Pre-treatment at baseline
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65.16 score on a scale
Standard Deviation 15.97
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Change in Score on the Tinnitus Functional Index (TFI)
Post-treatment at week 15
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41.95 score on a scale
Standard Deviation 24.42
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PRIMARY outcome
Timeframe: Baseline and Week 15Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
The TAQ captures the extent to which individuals accept their tinnitus, and attempts to avoid or control tinnitus, as well as a patient's ability to pursue valued life activities and meaningful goals regardless of tinnitus. 12 questions are scored from 0 = Never true to 6= Always true. Total scores on the TAQ range from 0-72, with a lower score indicating higher acceptance of symptoms.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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Tinnitus Acceptance Questionnaire (TAQ)
Pre-treatment at baseline
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35.10 score on a scale
Standard Deviation 8.28
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Tinnitus Acceptance Questionnaire (TAQ)
Post-treatment at 15 weeks
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46.88 score on a scale
Standard Deviation 13.65
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SECONDARY outcome
Timeframe: Baseline and Week 15Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
The DSI-SS will be used to assess current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Each item is rated on a 4 point scale, and the scores totaled for a potential range of 4-16, where a higher score indicates more severe degrees of suicide ideation.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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Depression Symptom Index Suicide Subscale (DSI-SS)
Post-treatment at 15 weeks
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7.38 score on a scale
Standard Deviation 4.98
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Depression Symptom Index Suicide Subscale (DSI-SS)
Pre-treatment at baseline
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14.10 score on a scale
Standard Deviation 6.59
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SECONDARY outcome
Timeframe: Baseline and Week 15Population: Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders that correspond to the diagnostic criteria for Major Depressive Disorder, outlined by the Diagnostic and Statistical Manual of Mental Disorders- 5th Edition (DSM-V, 2013). Each question is rated with a score of 0-3: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are the total for the nine questions with a possible range of 0-27, where a lower score indicates minimal depression and a higher score indicates severe depression.
Outcome measures
| Measure |
Interventional CPT
n=10 Participants
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions . CPT is delivered in three phases: education, processing, and challenging.
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Patient Health Questionnaire-9 (PHQ-9)
Pre-treatment at baseline
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14.10 score on a scale
Standard Deviation 6.59
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Patient Health Questionnaire-9 (PHQ-9)
Post-treatment at 15 weeks
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7.38 score on a scale
Standard Deviation 4.98
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Adverse Events
Interventional CPT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional CPT
n=10 participants at risk
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) for the alleviation of PTSD and tinnitus-related distress among individuals with co-morbid PTSD and tinnitus.
Cognitive Processing Therapy (CPT): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
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Psychiatric disorders
Increased irritablilty
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20.0%
2/10 • Number of events 2 • Baseline to 15 weeks
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Psychiatric disorders
Nightmares
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20.0%
2/10 • Number of events 2 • Baseline to 15 weeks
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Psychiatric disorders
Adverse memories triggered
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10.0%
1/10 • Number of events 1 • Baseline to 15 weeks
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Psychiatric disorders
Sadness
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10.0%
1/10 • Number of events 1 • Baseline to 15 weeks
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Psychiatric disorders
Anxiety
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10.0%
1/10 • Number of events 2 • Baseline to 15 weeks
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General disorders
Sleeplessness
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10.0%
1/10 • Number of events 1 • Baseline to 15 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place