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| ID | Type | Description | Link |
|---|---|---|---|
| 0 | Other Identifier | Institute of Psychiatry |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT specific for BDD | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT specific for BDD | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks, 1 month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Trust | London | SE5 8AZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25323062 | Result | Veale D, Anson M, Miles S, Pieta M, Costa A, Ellison N. Efficacy of cognitive behaviour therapy versus anxiety management for body dysmorphic disorder: a randomised controlled trial. Psychother Psychosom. 2014;83(6):341-53. doi: 10.1159/000360740. Epub 2014 Oct 16. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Inclusion criteria:
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
Data on adverse events was not collected or assessed for this study.
Data on adverse events was not collected or assessed for this study.
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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 | 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. |
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Small sample size: may have led to difficulty in identifying predictors of outcome.
Investigator bias: but testing blinding would be biased as it may be influenced by her rating of the outcome.
Treatment too brief to achieve sig. changes in BDD.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Veale | Institute of Psychiatry | 0203 228 3461 | david.veale@kcl.ac.uk |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C041398 | 7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester |
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|
| Non specific CBT | Behavioral | 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. |
|
| 12 weeks, 1 month post treatment |
| 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. | 12 weeks, 1 month post treatment |
| 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. | 12 weeks, 1 month post treatment |
| 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. | 12 weeks, 1 month post treatment |
| 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. | 12 weeks,1 month post treatment |
| 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. | 12 weeks, 1 month post treatment |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yale-Brown Obsessive Compulsive Scale modified for BDD (BDD-YBOCS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Brown Assessment of Beliefs Scale (BABS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks,1 month post treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks, 1 month post treatment |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 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. | 0 | 0 | 0 | 0 |
Not provided
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T-tests were used to investigate significant differences between baseline and 12 week measures
| t-test, 2 sided |
| <0.01 |
Bonferroni correction was used to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| T-tests were used to investigate significant differences between baseline and 1 month follow up. | t-test, 2 sided | < 0.001 | Bonferroni corrections were implemented to adjust for type I error | 2-Sided | No | Superiority or Other |
| T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures. | t-test, 2 sided | >0.05 | Bonferroni correction was used to decrease the risk of type I error. | 2-Sided | No | Superiority or Other |
| T-tests were used to investigate significant differences between baseline and 1 month follow up measures. | t-test, 2 sided | >0.05 | Bonferroni corrections were used to reduce risk of type I error | 2-Sided | No | Superiority or Other |
Investigating the difference in MADRS score between baseline and week 12.
| t-test, 2 sided |
| <0.01 |
Bonferroni correction was used to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| Investigating the difference in MADRS score between baseline and 1 month follow up. | t-test, 2 sided | >0.05 | Bonferonni corrections used to reduce risk of type I error | 2-Sided | No | Superiority or Other |
| Investigating the difference in MADRS score between baseline and week 12. | t-test, 2 sided | >0.05 | Bonferroni correction was used to decrease the risk of type I error. | 2-Sided | No | Superiority or Other |
| Investigating the difference in MADRS score between baseline and 1 month follow up. | t-test, 2 sided | > 0.05 | Bonferroni corrections used to decrease risk of type I error | 2-Sided | No | Superiority or Other |
Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .
| t-test, 2 sided |
| <0.001 |
Bonferroni corrections were applied to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up. | t-test, 2 sided | < 0.001 | Bonferroni corrections were used to reduce risk of type 1 error | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week . | t-test, 2 sided | <0.05 | Bonferroni Correction was used in an attempt to reduce risk of type I error. | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up. | t-test, 2 sided | >0.05 | Bonferroni corrections were used to adjust for type 1 error | 2-Sided | No | Superiority or Other |
Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).
| t-test, 2 sided |
| <0.05 |
Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up. | t-test, 2 sided | > 0.05 | Bonferroni corrections were used to reduce risk of type I error | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks). | t-test, 2 sided | >0.05 | A Bonferroni correction was used to decrease the risk of type I error. | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up. | t-test, 2 sided | > 0.05 | Bonferroni corrections were used to reduce risk of type I error. | 2-Sided | No | Superiority or Other |
Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.
| t-test, 2 sided |
| <0.01 |
A Bonferroni correction was used to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment. | t-test, 2 sided | > 0.05 | Bonferroni corrections were implemented to reduce the risk of type I error | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment. | t-test, 2 sided | >0.05 | A Bonferroni correction was used to decrease the risk of type I error. | 2-Sided | No | Superiority or Other |
| Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment. | t-test, 2 sided | > 0.05 | Bonferroni corrections were used to reduce risk of type I error | 2-Sided | No | Superiority or Other |
Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).
| t-test, 2 sided |
| <0.05 |
A Bonferroni correction was used to decrease the risk of type I error. |
| 2-Sided |
| No |
| Superiority or Other |
| Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up. | t-test, 2 sided | < 0.05 | Bonferroni corrections were used to reduce risk of type 1 error | 2-Sided | No | Superiority or Other |
| Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks). | t-test, 2 sided | >0.05 | A Bonferroni correction was used to decrease the risk of type I error. | 2-Sided | No | Superiority or Other |
| Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up. | t-test, 2 sided | > 0.05 | Bonferroni corrections were used | 2-Sided | No | Superiority or Other |