Trial Outcomes & Findings for Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD) (NCT NCT00871143)
NCT ID: NCT00871143
Last Updated: 2015-10-06
Results Overview
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.
COMPLETED
NA
46 participants
12 weeks, 1 month post treatment
2015-10-06
Participant Flow
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.
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.
Participant milestones
| Measure |
CBT Specific for BDD
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Baseline characteristics by cohort
| Measure |
CBT Specific for BDD
n=21 Participants
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.
|
Non Specific CBT
n=25 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.0 years
n=5 Participants
|
29.0 years
n=7 Participants
|
30.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Yale-Brown Obsessive Compulsive Scale modified for BDD (BDD-YBOCS)
|
35.48 units on a scale
STANDARD_DEVIATION 6.61 • n=5 Participants
|
37.68 units on a scale
STANDARD_DEVIATION 4.77 • n=7 Participants
|
36.58 units on a scale
STANDARD_DEVIATION 5.69 • n=5 Participants
|
|
Brown Assessment of Beliefs Scale (BABS)
|
18.24 units on a scale
STANDARD_DEVIATION 4.68 • n=5 Participants
|
18.96 units on a scale
STANDARD_DEVIATION 4.14 • n=7 Participants
|
18.60 units on a scale
STANDARD_DEVIATION 4.41 • n=5 Participants
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
|
28.57 units on a scale
STANDARD_DEVIATION 10.69 • n=5 Participants
|
30.04 units on a scale
STANDARD_DEVIATION 9.62 • n=7 Participants
|
29.31 units on a scale
STANDARD_DEVIATION 10.16 • n=5 Participants
|
|
Appearance Anxiety Inventory (AAI)
|
26.89 units on a scale
STANDARD_DEVIATION 6.62 • n=5 Participants
|
27.78 units on a scale
STANDARD_DEVIATION 7.03 • n=7 Participants
|
27.335 units on a scale
STANDARD_DEVIATION 6.83 • n=5 Participants
|
|
Patient Health Questionnaire (PHQ)-9
|
13.10 units on a scale
STANDARD_DEVIATION 6.50 • n=5 Participants
|
13.60 units on a scale
STANDARD_DEVIATION 5.44 • n=7 Participants
|
13.35 units on a scale
STANDARD_DEVIATION 5.97 • n=5 Participants
|
|
Generalised Anxiety Disorder (GAD)-7
|
11.33 units on a scale
STANDARD_DEVIATION 6.32 • n=5 Participants
|
13.09 units on a scale
STANDARD_DEVIATION 5.24 • n=7 Participants
|
12.21 units on a scale
STANDARD_DEVIATION 5.78 • n=5 Participants
|
|
Body Image Quality of Life Inventory (BIQLI)
|
-1.97 units on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
-1.68 units on a scale
STANDARD_DEVIATION 1.04 • n=7 Participants
|
-1.83 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks, 1 month post treatmentThis 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
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
|
32.87 units on a scale
Standard Deviation 7.45
|
|
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
|
33.30 units on a scale
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: 12 weeks, 1 month post treatmentBABS 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
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
|
17.92 units on a scale
Standard Deviation 5.42
|
|
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
|
18.88 units on a scale
Standard Deviation 4.62
|
SECONDARY outcome
Timeframe: 12 weeks, 1 month post treatmentMADRS 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).
12 week
|
21.71 units on a scale
Standard Deviation 11.20
|
25.98 units on a scale
Standard Deviation 10.80
|
|
Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).
1 month
|
20.40 units on a scale
Standard Deviation 13.14
|
28.63 units on a scale
Standard Deviation 13.32
|
SECONDARY outcome
Timeframe: 12 weeks, 1 month post treatmentThe 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Appearance Anxiety Inventory (AAI)
12 week
|
14.61 units on a scale
Standard Deviation 9.20
|
23.37 units on a scale
Standard Deviation 8.29
|
|
Appearance Anxiety Inventory (AAI)
1 month
|
14.16 units on a scale
Standard Deviation 9.53
|
23.21 units on a scale
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: 12 weeks, 1 month post treatmentThe 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ)-9
12 week
|
9.12 units on a scale
Standard Deviation 7.01
|
13.28 units on a scale
Standard Deviation 7.18
|
|
Patient Health Questionnaire (PHQ)-9
1 month
|
9.41 units on a scale
Standard Deviation 6.67
|
15.79 units on a scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: 12 weeks,1 month post treatmentThe 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Generalised Anxiety Disorder (GAD)-7
12 week
|
7.00 units on a scale
Standard Deviation 6.02
|
11.59 units on a scale
Standard Deviation 5.89
|
|
Generalised Anxiety Disorder (GAD)-7
1 month
|
8.53 units on a scale
Standard Deviation 6.60
|
13.22 units on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 12 weeks, 1 month post treatmentThe 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.
Outcome measures
| Measure |
CBT Specific for BDD
n=21 Participants
CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
|
Non Specific CBT
n=25 Participants
Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
|
|---|---|---|
|
Body Image Quality of Life Inventory (BIQLI)
12 week
|
-1.43 units on a scale
Standard Deviation 0.85
|
-2.04 units on a scale
Standard Deviation 0.71
|
|
Body Image Quality of Life Inventory (BIQLI)
1 month
|
-1.29 units on a scale
Standard Deviation 0.92
|
-1.95 units on a scale
Standard Deviation 0.81
|
Adverse Events
CBT Specific for BDD
Non Specific CBT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place