Body Dysmorphic Disorder
Conditions
Keywords
CBT, BDD
Brief summary
The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD is more effective than a credible non-specific form of CBT for treating BDD and its delusional variant in adults aged 17 or over. This will be done in a single centre randomised controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks. The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1 month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. A secondary aim is to explore whether delusionality (insight) as measured by the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.
Interventions
This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
Sponsors
Study design
Eligibility
Inclusion criteria
* BDD is the main psychological problem. We will use DSMIV criteria as BDD does not exist as a separate diagnosis in ICD10. They may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective. * They must have a total of 24 or more on the twelve-item YBOCS modified for BDD (Phillips et al., 1997). * They may be of either gender but must be 17 years or above. * They are willing to travel to the treatment centre for weekly sessions. * They are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning. * They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose.
Exclusion criteria
* They have a current or past diagnosis of schizophrenia, bipolar affective disorder. * They have current suicidal intent or severe self-neglect that requires hospitalisation. * They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right. * They are currently receiving any other form of psychotherapy, * They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond. * They cannot speak sufficient English for CBT. (Assistance will be provided for those who speak English but are unable to read questionnaires).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) | 12 weeks, 1 month post treatment | This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). | 12 weeks, 1 month post treatment | MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating 'normal' or 'no difficulties') to 6, and the range is 0-60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of \>31 as severe. |
| Appearance Anxiety Inventory (AAI) | 12 weeks, 1 month post treatment | The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 ('not at all') to 4 ('all the time'), and the range of the total scores is 0-40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach's α of 0.86. |
| Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) | 12 weeks, 1 month post treatment | BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. 'I am as ugly as the Elephant man'); each item is rated from 0 ('non-delusional belief, or least pathological') to 4 ('delusional belief, or most pathological') and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate. |
| Generalised Anxiety Disorder (GAD)-7 | 12 weeks,1 month post treatment | The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach's α for the measure is 0.92. |
| Body Image Quality of Life Inventory (BIQLI) | 12 weeks, 1 month post treatment | The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from -3 ('very negative effect') to +3 ('very positive effect'); Cronbach's α for the scale is 0.95. |
| Patient Health Questionnaire (PHQ)-9 | 12 weeks, 1 month post treatment | The PHQ is a 9-item self-report measure of depression; each item is scored from 0 ('not at all') to 3 ('nearly every day'),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach's α for the scale is 0.89. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment: April 2009-March 2012. Single location: outpatient clinic at the Centre for Anxiety Disorders and Trauma at the Maudsley Hospital, London. Follow-ups: December 2009- September 2012. The trial ended when all participants had completed the follow-up. Last participant was recruited March 2012;last follow up was completed Sept 2012.
Pre-assignment details
It was initially decided that 42 participants would be enrolled in the study (21 in each group), however in order to anticipate potential future drop outs, 46 participants were randomised into the 2 groups.
Participants by arm
| Arm | Count |
|---|---|
| CBT Specific for BDD This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears. | 21 |
| Non Specific CBT Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations. | 25 |
| Total | 46 |
Baseline characteristics
| Characteristic | CBT Specific for BDD | Non Specific CBT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 25 Participants | 46 Participants |
| Age, Continuous | 30.0 years | 29.0 years | 30.0 years |
| Appearance Anxiety Inventory (AAI) | 26.89 units on a scale STANDARD_DEVIATION 6.62 | 27.78 units on a scale STANDARD_DEVIATION 7.03 | 27.335 units on a scale STANDARD_DEVIATION 6.83 |
| Body Image Quality of Life Inventory (BIQLI) | -1.97 units on a scale STANDARD_DEVIATION 0.56 | -1.68 units on a scale STANDARD_DEVIATION 1.04 | -1.83 units on a scale STANDARD_DEVIATION 0.8 |
| Brown Assessment of Beliefs Scale (BABS) | 18.24 units on a scale STANDARD_DEVIATION 4.68 | 18.96 units on a scale STANDARD_DEVIATION 4.14 | 18.60 units on a scale STANDARD_DEVIATION 4.41 |
| Generalised Anxiety Disorder (GAD)-7 | 11.33 units on a scale STANDARD_DEVIATION 6.32 | 13.09 units on a scale STANDARD_DEVIATION 5.24 | 12.21 units on a scale STANDARD_DEVIATION 5.78 |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 28.57 units on a scale STANDARD_DEVIATION 10.69 | 30.04 units on a scale STANDARD_DEVIATION 9.62 | 29.31 units on a scale STANDARD_DEVIATION 10.16 |
| Patient Health Questionnaire (PHQ)-9 | 13.10 units on a scale STANDARD_DEVIATION 6.5 | 13.60 units on a scale STANDARD_DEVIATION 5.44 | 13.35 units on a scale STANDARD_DEVIATION 5.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 21 Participants | 37 Participants |
| Region of Enrollment United Kingdom | 21 participants | 25 participants | 46 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
| Yale-Brown Obsessive Compulsive Scale modified for BDD (BDD-YBOCS) | 35.48 units on a scale STANDARD_DEVIATION 6.61 | 37.68 units on a scale STANDARD_DEVIATION 4.77 | 36.58 units on a scale STANDARD_DEVIATION 5.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)
This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) | 12 weeks | 23.47 units on a scale | Standard Deviation 11.23 |
| CBT Specific for BDD | Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) | 1 month | 21.37 units on a scale | Standard Deviation 12.42 |
| Non Specific CBT | Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) | 12 weeks | 32.87 units on a scale | Standard Deviation 7.45 |
| Non Specific CBT | Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) | 1 month | 33.30 units on a scale | Standard Deviation 8.72 |
Appearance Anxiety Inventory (AAI)
The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 ('not at all') to 4 ('all the time'), and the range of the total scores is 0-40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach's α of 0.86.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Appearance Anxiety Inventory (AAI) | 12 week | 14.61 units on a scale | Standard Deviation 9.2 |
| CBT Specific for BDD | Appearance Anxiety Inventory (AAI) | 1 month | 14.16 units on a scale | Standard Deviation 9.53 |
| Non Specific CBT | Appearance Anxiety Inventory (AAI) | 12 week | 23.37 units on a scale | Standard Deviation 8.29 |
| Non Specific CBT | Appearance Anxiety Inventory (AAI) | 1 month | 23.21 units on a scale | Standard Deviation 8.86 |
Body Image Quality of Life Inventory (BIQLI)
The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from -3 ('very negative effect') to +3 ('very positive effect'); Cronbach's α for the scale is 0.95.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Body Image Quality of Life Inventory (BIQLI) | 12 week | -1.43 units on a scale | Standard Deviation 0.85 |
| CBT Specific for BDD | Body Image Quality of Life Inventory (BIQLI) | 1 month | -1.29 units on a scale | Standard Deviation 0.92 |
| Non Specific CBT | Body Image Quality of Life Inventory (BIQLI) | 12 week | -2.04 units on a scale | Standard Deviation 0.71 |
| Non Specific CBT | Body Image Quality of Life Inventory (BIQLI) | 1 month | -1.95 units on a scale | Standard Deviation 0.81 |
Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)
BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. 'I am as ugly as the Elephant man'); each item is rated from 0 ('non-delusional belief, or least pathological') to 4 ('delusional belief, or most pathological') and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) | 12 week | 12.75 units on a scale | Standard Deviation 8.11 |
| CBT Specific for BDD | Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) | 1 month | 10.28 units on a scale | Standard Deviation 7.41 |
| Non Specific CBT | Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) | 12 week | 17.92 units on a scale | Standard Deviation 5.42 |
| Non Specific CBT | Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) | 1 month | 18.88 units on a scale | Standard Deviation 4.62 |
Generalised Anxiety Disorder (GAD)-7
The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach's α for the measure is 0.92.
Time frame: 12 weeks,1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Generalised Anxiety Disorder (GAD)-7 | 12 week | 7.00 units on a scale | Standard Deviation 6.02 |
| CBT Specific for BDD | Generalised Anxiety Disorder (GAD)-7 | 1 month | 8.53 units on a scale | Standard Deviation 6.6 |
| Non Specific CBT | Generalised Anxiety Disorder (GAD)-7 | 12 week | 11.59 units on a scale | Standard Deviation 5.89 |
| Non Specific CBT | Generalised Anxiety Disorder (GAD)-7 | 1 month | 13.22 units on a scale | Standard Deviation 5.45 |
Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).
MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating 'normal' or 'no difficulties') to 6, and the range is 0-60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of \>31 as severe.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). | 12 week | 21.71 units on a scale | Standard Deviation 11.2 |
| CBT Specific for BDD | Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). | 1 month | 20.40 units on a scale | Standard Deviation 13.14 |
| Non Specific CBT | Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). | 12 week | 25.98 units on a scale | Standard Deviation 10.8 |
| Non Specific CBT | Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). | 1 month | 28.63 units on a scale | Standard Deviation 13.32 |
Patient Health Questionnaire (PHQ)-9
The PHQ is a 9-item self-report measure of depression; each item is scored from 0 ('not at all') to 3 ('nearly every day'),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach's α for the scale is 0.89.
Time frame: 12 weeks, 1 month post treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT Specific for BDD | Patient Health Questionnaire (PHQ)-9 | 12 week | 9.12 units on a scale | Standard Deviation 7.01 |
| CBT Specific for BDD | Patient Health Questionnaire (PHQ)-9 | 1 month | 9.41 units on a scale | Standard Deviation 6.67 |
| Non Specific CBT | Patient Health Questionnaire (PHQ)-9 | 12 week | 13.28 units on a scale | Standard Deviation 7.18 |
| Non Specific CBT | Patient Health Questionnaire (PHQ)-9 | 1 month | 15.79 units on a scale | Standard Deviation 7.05 |