Trial Outcomes & Findings for Clinical Management of Anxiety and Access to Health Care (NCT NCT02081365)
NCT ID: NCT02081365
Last Updated: 2017-01-27
Results Overview
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.
COMPLETED
NA
151 participants
Change from one week before dentist appointment to 1 month after dentist appointment
2017-01-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
77
|
|
Overall Study
Received Allocated Intervention
|
46
|
59
|
|
Overall Study
COMPLETED
|
44
|
54
|
|
Overall Study
NOT COMPLETED
|
30
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Management of Anxiety and Access to Health Care
Baseline characteristics by cohort
| Measure |
Immediate Treatment
n=74 Participants
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.
|
Waiting List Control
n=77 Participants
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.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
44.6 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
44.7 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Gender
Female
|
52 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Gender
Male
|
22 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
34 participants
n=99 Participants
|
44 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not reported/missing
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
MDAS Baseline Score
|
19.5 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
ADIS Specific Phobia Fear Rating
|
5.6 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.4 • n=107 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
ADIS Specific Phobia Avoidance Rating
|
4.6 units on a scale
STANDARD_DEVIATION 2.2 • n=99 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
ADIS Specific Phobia Clinical Severity Rating
|
5.3 units on a scale
STANDARD_DEVIATION 1.4 • n=99 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.6 • n=107 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Change from one week before dentist appointment to 1 month after dentist appointmentThe 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.
Outcome measures
| Measure |
Immediate Treatment
n=74 Participants
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.
|
Waiting List Control
n=77 Participants
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.
|
|---|---|---|
|
Change in Modified Dental Anxiety Scale
Baseline
|
19.5 units on a scale
Standard Error 0.34
|
19.6 units on a scale
Standard Error 0.30
|
|
Change in Modified Dental Anxiety Scale
One month follow up
|
15.4 units on a scale
Standard Error 0.74
|
17.6 units on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Change from one week before dental appointment to one-month after dental appointmentThe 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.
Outcome measures
| Measure |
Immediate Treatment
n=52 Participants
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.
|
Waiting List Control
n=63 Participants
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.
|
|---|---|---|
|
Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Baseline
|
5.3 units on a scale
Standard Error 0.19
|
4.8 units on a scale
Standard Error 0.20
|
|
Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
One month follow up
|
3.4 units on a scale
Standard Error 0.27
|
4.0 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Change from one week before appointment to one month after appointmentThe 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.
Outcome measures
| Measure |
Immediate Treatment
n=52 Participants
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.
|
Waiting List Control
n=63 Participants
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.
|
|---|---|---|
|
Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Baseline
|
5.6 units on a scale
Standard Error 0.17
|
5.2 units on a scale
Standard Error 0.17
|
|
Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
One month follow up
|
3.8 units on a scale
Standard Error 0.26
|
4.8 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Change from one week before appointment to one month after appointmentThe 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.
Outcome measures
| Measure |
Immediate Treatment
n=52 Participants
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.
|
Waiting List Control
n=63 Participants
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.
|
|---|---|---|
|
Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
Baseline
|
4.6 units on a scale
Standard Error 0.31
|
3.9 units on a scale
Standard Error 0.32
|
|
Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV
One month follow up
|
1.3 units on a scale
Standard Error 0.31
|
1.0 units on a scale
Standard Error 0.29
|
Adverse Events
Immediate Treatment
Waiting List Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marisol Tellez M. BDS, MPH, Ph.D
Maurice H. Kornberg School of Dentistry, Temple University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place