Body Dysmorphic Disorder
Conditions
Keywords
Body Dysmorphic Disorder, SRIs, Cognitive Behavioral Therapy
Brief summary
The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment
Detailed description
In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).
Interventions
BEHAVIORALCognitive Behavioral Therapy
standard psychiatric evaluation
DRUGVenlafaxine
start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 16-65 * A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic type) * Ability to communicate meaningfully with the investigators * Competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months * Parental consent, if under 18 years old * For phase two: must be on a stable therapeutic dose of one of the following SRI medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline.
Exclusion criteria
* current or lifetime diagnosis of any DSM\_IV psychotic disorder not attributable to delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder, * current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse, * recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization, * need for inpatient or partial hospital treatment, * use of any medication prescribed for the treatment of BDD other than SRIs, including tricyclic antidepressants, buspirone, or neuroleptics, * presence of any significant and/or unstable medical condition, * females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Dysmorphic Disorder Examination | baseline and up to 16 weeks | Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180. |
| Yale Brown Obsessive Scale | baseline and up to 16 weeks | Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content. |
| Body Dysmorphic Disorder Clinical Global Impressions Scale | baseline and up to 16 weeks | The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brown Assessment of Beliefs Scale | Baseline and up to 16 weeks | The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24. |
| Beck Depression Inventory II | Baseline and up to 16 weeks | The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms. |
| Beck Anxiety Inventory | Baseline and up to 16 weeks | The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by advertising and other media and by referral from outside clinicians.
Participants by arm
| Arm | Count |
|---|---|
| Body Dysmorphic Disorder Participants with body dysmorphic disorder | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Pregnancy | 1 |
| Overall Study | side effects | 2 |
Baseline characteristics
| Characteristic | Body Dysmorphic Disorder |
|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 8.4 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 2 Participants |
| SSRI history prior failed SSRI trials | 10 Participants |
| SSRI history SSRI naive | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Body Dysmorphic Disorder Clinical Global Impressions Scale
The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: baseline and up to 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Body Dysmorphic Disorder Clinical Global Impressions Scale | Psychiatrist's Ratings | 2.73 units on a scale | Standard Deviation 0.91 |
| Baseline | Body Dysmorphic Disorder Clinical Global Impressions Scale | Psychologist's Ratings | 3.00 units on a scale | Standard Deviation 1 |
Primary
Body Dysmorphic Disorder Examination
Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.
Time frame: baseline and up to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Body Dysmorphic Disorder Examination | 113.91 units on a scale | Standard Deviation 27.41 |
| Endpoint | Body Dysmorphic Disorder Examination | 107.73 units on a scale | Standard Deviation 39.93 |
Primary
Yale Brown Obsessive Scale
Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.
Time frame: baseline and up to 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Total | 34.64 units on a scale | Standard Deviation 5.09 |
| Baseline | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Obsessions | 14.73 units on a scale | Standard Deviation 2.2 |
| Baseline | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Compulsions | 14.82 units on a scale | Standard Deviation 1.2 |
| Baseline | Yale Brown Obsessive Scale | Psychologist's Ratings for Total | 35.91 units on a scale | Standard Deviation 4.21 |
| Baseline | Yale Brown Obsessive Scale | Psychologist's Ratings for Obsessions | 14.45 units on a scale | Standard Deviation 4.57 |
| Baseline | Yale Brown Obsessive Scale | Psychologist's Ratings for Compulsions | 16.09 units on a scale | Standard Deviation 2.3 |
| Endpoint | Yale Brown Obsessive Scale | Psychologist's Ratings for Obsessions | 12.09 units on a scale | Standard Deviation 4.72 |
| Endpoint | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Total | 26.55 units on a scale | Standard Deviation 11.28 |
| Endpoint | Yale Brown Obsessive Scale | Psychologist's Ratings for Total | 28.27 units on a scale | Standard Deviation 9.49 |
| Endpoint | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Obsessions | 11.45 units on a scale | Standard Deviation 5.03 |
| Endpoint | Yale Brown Obsessive Scale | Psychologist's Ratings for Compulsions | 12.18 units on a scale | Standard Deviation 3.84 |
| Endpoint | Yale Brown Obsessive Scale | Psychiatrist's Ratings for Compulsions | 11.55 units on a scale | Standard Deviation 4.93 |
Secondary
Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.
Time frame: Baseline and up to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Beck Anxiety Inventory | 16.90 units on a scale | Standard Deviation 8.23 |
| Endpoint | Beck Anxiety Inventory | 12.55 units on a scale | Standard Deviation 10.86 |
Secondary
Beck Depression Inventory II
The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Time frame: Baseline and up to 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Beck Depression Inventory II | 28.77 units on a scale | Standard Deviation 11.49 |
| Endpoint | Beck Depression Inventory II | 22.18 units on a scale | Standard Deviation 15.3 |
Secondary
Brown Assessment of Beliefs Scale
The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.
Time frame: Baseline and up to 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Brown Assessment of Beliefs Scale | Psychiatrist's Ratings | 15.82 units on a scale | Standard Deviation 5.19 |
| Baseline | Brown Assessment of Beliefs Scale | Psychologist's Ratings | 15.91 units on a scale | Standard Deviation 6.47 |
| Endpoint | Brown Assessment of Beliefs Scale | Psychiatrist's Ratings | 16.91 units on a scale | Standard Deviation 4.7 |
| Endpoint | Brown Assessment of Beliefs Scale | Psychologist's Ratings | 14.82 units on a scale | Standard Deviation 6.46 |