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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that could be easily implemented in dental healthcare settings.
A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).
Analyses of covariance (ANCOVAs) based on intention to treat analyses were used to compare the two groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Anxiety Computerized Dental Anxiety Treatment | Experimental | Computer based CBT intervention before the scheduled dental appoinment (1.5 hours) |
|
| High Anxiety Wailist Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Dental Anxiety Treatment | Behavioral | The Computerized Dental Anxiety Treatment Program consists of treatment modules that are be delivered through a computer. The modules use Cognitive Behavioral Therapy (CBT) to assist the participant in preparing a personal plan for managing his/her dental anxiety. The program incorporates a range of CBT techniques, including cognitive restructuring, exposure, and motivational interviewing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Dental Anxiety Scale | The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, "If you went to your dentist for treatment tomorrow, how would you feel?" and "If you were about to have your tooth drilled, how would you feel?" Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety. | Change from one week before dentist appointment to 1 month after dentist appointment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisol Tellez, Ph.D. | Temple University Kornberg School or Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Kornberg School of Dentistry | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26202996 | Derived | Tellez M, Potter CM, Kinner DG, Jensen D, Waldron E, Heimberg RG, Myers Virtue S, Zhao H, Ismail AI. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):174S-80S. doi: 10.1177/0022034515598134. Epub 2015 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment | Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT). The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
| FG001 | Waiting List Control | Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients were between 18 and 70 years, fluent in English, had scheduled a dental treatment appointment at the clinic, were willing and able to give informed written consent, met criteria for high dental anxiety based on the Modified Dental Anxiety Scale, and endorsed at least some oral-health related impairment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment | Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT). The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Modified Dental Anxiety Scale | The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, "If you went to your dentist for treatment tomorrow, how would you feel?" and "If you were about to have your tooth drilled, how would you feel?" Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety. | Posted | Mean | Standard Error | units on a scale | Change from one week before dentist appointment to 1 month after dentist appointment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Treatment | Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT). The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marisol Tellez M. BDS, MPH, Ph.D | Maurice H. Kornberg School of Dentistry, Temple University | 215-707-1773 | marisol@temple.edu |
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|
| Change from one week before dental appointment to one-month after dental appointment |
| Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Change from one week before appointment to one month after appointment |
| Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Change from one week before appointment to one month after appointment |
| BG001 | Waiting List Control | Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| MDAS Baseline Score | Modified Dental Anxiety Scale Baseline Score (0-25 scale). We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety. | Mean | Standard Deviation | units on a scale |
|
| ADIS Specific Phobia Fear Rating | Anxiety Disorders Interview Schedule for DSM-IV Specific Phobia Module Fear Rating 0 (none) to 8 (very severe). | Mean | Standard Deviation | units on a scale |
|
| ADIS Specific Phobia Avoidance Rating | Anxiety Disorders Interview Schedule for DSM-IV Specific Phobia Module Avoidance Rating (0-8 scale). 0 (none) to 8 (very severe). | Mean | Standard Deviation | units on a scale |
|
| ADIS Specific Phobia Clinical Severity Rating | Anxiety Disorders Interview Schedule for DSM-IV Specific Phobia Module Clinical Severity Rating (0-8 scale) 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Waiting List Control | Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. |
|
|
|
| Secondary | Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Posted | Mean | Standard Error | units on a scale | Change from one week before dental appointment to one-month after dental appointment |
|
|
|
|
| Secondary | Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Posted | Mean | Standard Error | units on a scale | Change from one week before appointment to one month after appointment |
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|
| Secondary | Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV | The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia. | Posted | Mean | Standard Error | units on a scale | Change from one week before appointment to one month after appointment |
|
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Waiting List Control | Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments. One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments. | 0 | 77 | 0 | 77 |
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