Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Completed
• CT.gov ID: NCT03702166
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Evaluation of the overlap between tinnitus-related distress and symptoms of Post Traumatic Stress Disorder (PTSD), to identify functional covariance among resting-state networks among individuals with tinnitus and PTSD

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic; Tinnitus	Behavioral: Cognitive Processing Therapy (CPT)	N/A

Detailed Description

The purpose of this study is to characterize tinnitus and PTSD symptomatically, neurobiologically, and causally, applying causal modeling to psychometric and neurofunctional data. We will enroll 30 individuals with both tinnitus and PTSD. Participants will be asked to complete baseline assessments of subjective tinnitus distress, PTSD, depression, and resting-state fMRI at baseline. Individuals with comorbid tinnitus and PTSD who are eligible for the study will receive 12 sessions of Cognitive Processing Therapy (CPT) over a 6- to 15-week period. CPT is a trauma-focused treatment for PTSD that guides individuals on how to recognize and challenge thoughts that are erroneous and dysfunctional. One-month follow-up assessments of tinnitus-related distress, PTSD, depression, and anxiety will be conducted, along with resting-state functional magnetic resonance imaging (fMRI).

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
• Actual Study Start Date: Jan 4, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Aug 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Behavioral: 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.; Other Names: CPT

Outcome Measures

Primary Outcome Measures

1. Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) [Baseline and Week 15]

   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.

2. Change in Score on the PTSD Check List-5 (PCL-5) [Baseline and Week 15]

   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.

3. Change in Score on the Tinnitus Functional Index (TFI) [Baseline and Week 15]

   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.

4. Tinnitus Acceptance Questionnaire (TAQ) [Baseline and Week 15]

   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.

Secondary Outcome Measures

1. Depression Symptom Index Suicide Subscale (DSI-SS) [Baseline and Week 15]

   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.

2. Patient Health Questionnaire-9 (PHQ-9) [Baseline and Week 15]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult military Veterans (age 18-60) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD and/or tinnitus

• Diagnosis of PTSD determined by the Clinician-Administered PTSD Scale - Interview - Version 5 (CAPS-5)

• Ability to speak and read English

• Meets criteria for tinnitus and considers their tinnitus bothersome, as defined by a score on the Tinnitus Functional Index of 32 or greater

Exclusion Criteria:

• Currently receiving evidence based treatment for PTSD

• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index- Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider

• Psychiatric hospitalization in the last 12 months

• Current and severe alcohol use warranting immediate intervention based on clinical judgment

• Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the manic and psychosis modules of the MINI)

• Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)

• Neurobiological disorders

• Meniere's disease, temporomandibular joint disorders

• History of seizures

• History of penetrating head trauma or neurosurgery

• Metal objects implanted in the head, ferrous metal filings in the eye

• Inflammation of the brain

• Cardiac pacemaker

• Implanted medical pump or cardiac lines

• Heart disease

• Currently taking certain types of medication for depression or seizures (tricyclic antidepressants or neuroleptics which lower seizure threshold)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: John C Moring, PhD, UT Health San Antonio

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2020

More Information

Publications

None provided.

• Responsible Party: John Moring, John Moring, PhD, The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT03702166
• Other Study ID Numbers: HSC20180524H; 1KL2TR002646-01
• First Posted: Oct 10, 2018
• Last Update Posted: May 26, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tinnitus; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	8
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Overall Participants	10
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.3 (9.75)
Sex: Female, Male (Count of Participants)
Female	1 10%
Male	9 90%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 50%
Not Hispanic or Latino	5 50%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Change in Score on Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	33.10 (7.50)
Post-treatment at 15 weeks	16.13 (14.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interventional CPT
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	t-test, 1 sided
	Comments	Multiple t-tests with Bonferroni corrections for multiple comparisons

2. Primary Outcome

Title	Change in Score on the PTSD Check List-5 (PCL-5)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline at pre-treatment included 10 subjects, post-treatment included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	42.7 (12.25)
Post-treatment at 15 weeks	17.75 (18.91)

3. Primary Outcome

Title	Change in Score on the Tinnitus Functional Index (TFI)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	65.16 (15.97)
Post-treatment at week 15	41.95 (24.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interventional CPT
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments
	Method	t-test, 1 sided
	Comments	Multiple t-tests, with Bonferroni corrections for multiple comparisons,

4. Primary Outcome

Title	Tinnitus Acceptance Questionnaire (TAQ)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	35.10 (8.28)
Post-treatment at 15 weeks	46.88 (13.65)

5. Secondary Outcome

Title	Depression Symptom Index Suicide Subscale (DSI-SS)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	14.10 (6.59)
Post-treatment at 15 weeks	7.38 (4.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interventional CPT
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments	Multiple t-tests, with Bonferroni corrections for multiple comparisons
	Method	t-test, 1 sided
	Comments

6. Secondary Outcome

Title	Patient Health Questionnaire-9 (PHQ-9)
Description	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.
Time Frame	Baseline and Week 15

Outcome Measure Data

Analysis Population Description

Baseline scores pre-treatment included 10 subjects, post-treatment scores included only 8 subjects who completed the study.

Arm/Group Title	Interventional CPT
Arm/Group Description	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.
Measure Participants	10
Pre-treatment at baseline	14.10 (6.59)
Post-treatment at 15 weeks	7.38 (4.98)

Adverse Events

Time Frame	Baseline to 15 weeks
Arm/Group Title	Interventional CPT
Arm/Group Description	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.
All Cause Mortality
	Interventional CPT
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Interventional CPT
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Interventional CPT
	Affected / at Risk (%)	# Events
Total	5/10 (50%)
General disorders
Sleeplessness	1/10 (10%)	1
Psychiatric disorders
Increased irritablilty	2/10 (20%)	2
Nightmares	2/10 (20%)	2
Adverse memories triggered	1/10 (10%)	1
Sadness	1/10 (10%)	1
Anxiety	1/10 (10%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.