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The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Participants will receive placebo augmented cognitive behavioral therapy |
|
| D-Cycloserine | Experimental | Participants will receive D-Cycloserine augmented cognitive behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Cognitive Behavioral Therapy (CBT) | Behavioral | The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT. |
| Measure | Description | Time Frame |
|---|---|---|
| Acrophobia Questionnaire With Avoidance (AAVQ) | Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes Towards Heights Questionnaire (ATHQ) | Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0-10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasper Smits, Ph.D. | Southern Methodist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Methodist University | Dallas | Texas | 75206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332511 | Derived | Smits JA, Rosenfield D, Otto MW, Powers MB, Hofmann SG, Telch MJ, Pollack MH, Tart CD. D-cycloserine enhancement of fear extinction is specific to successful exposure sessions: evidence from the treatment of height phobia. Biol Psychiatry. 2013 Jun 1;73(11):1054-8. doi: 10.1016/j.biopsych.2012.12.009. Epub 2013 Jan 16. | |
| 23098672 |
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76 individuals were assessed for eligibility, of which 47 were excluded due to not having a diagnosis of acrophobia (n=37) or declining participation (n=10). 29 individuals were randomized and no participants were excluded after enrollment but prior to group assignment.
Participants (N = 29; Mean age = 33.38) with acrophobia were recruited from Southern Methodist University and the greater Dallas area from 2009 to 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Participants will receive sugar pill placebo augmented cognitive behavioral therapy |
| FG001 | D-Cycloserine | Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Post-Treatment |
|
| ||||||||||||||||||
| Post to Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Participants will receive sugar pill placebo augmented cognitive behavioral therapy |
| BG001 | D-Cycloserine | Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Acrophobia Questionnaire With Avoidance (AAVQ) | Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
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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 | DCS+CBT | CBT augmented with DCS (50mg) |
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Sample may not have been severe enough to see an effect of DCS; there may have been a ceiling effect; there was no pre-session pill administration; assessors were blind but not independent; only one dose of DCS was examined
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jasper Smits | Southern Methodist University | 214-768-4125 | jsmits@smu.edu |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| C000719188 | Acrophobia |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D-Cycloserine | Drug | D-Cycloserine |
|
| Placebo | Drug | Sugar Pill |
|
| 2 months |
| Clinical Global Improvement Scale (CGI) | Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either "very much improved" or "much improved" on CGI-I (score ≤ 2). Remission was defined as either "normal" or "minimally ill" on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome. | 2 months |
| Behavioral Avoidance Test (BAT) | During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0-100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome. | 2 months |
| Tart CD, Handelsman PR, Deboer LB, Rosenfield D, Pollack MH, Hofmann SG, Powers MB, Otto MW, Smits JA. Augmentation of exposure therapy with post-session administration of D-cycloserine. J Psychiatr Res. 2013 Feb;47(2):168-74. doi: 10.1016/j.jpsychires.2012.09.024. Epub 2012 Oct 23. |
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|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants receiving PL augmented CBT |
|
|
| Secondary | Attitudes Towards Heights Questionnaire (ATHQ) | Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0-10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Clinical Global Improvement Scale (CGI) | Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either "very much improved" or "much improved" on CGI-I (score ≤ 2). Remission was defined as either "normal" or "minimally ill" on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| Secondary | Behavioral Avoidance Test (BAT) | During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0-100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Pill Placebo + CBT | CBT augmented with sugar pill placebo | 0 | 29 | 0 | 29 |
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |