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Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Efficacy of Cognitive Behaviour Therapy -v- Anxiety Management for Body Dysmorphic Disorder: a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00871143
Enrollment
46
Registered
2009-03-30
Start date
2009-04-30
Completion date
2012-09-30
Last updated
2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Dysmorphic Disorder

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

BEHAVIORALCBT 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.

BEHAVIORALNon 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.

Sponsors

Institute of Psychiatry, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)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.

Secondary

MeasureTime frameDescription
Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).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.
Appearance Anxiety Inventory (AAI)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.
Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)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.
Generalised Anxiety Disorder (GAD)-712 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.
Body Image Quality of Life Inventory (BIQLI)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.
Patient Health Questionnaire (PHQ)-912 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.

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

ArmCount
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
Total46

Baseline characteristics

CharacteristicCBT Specific for BDDNon Specific CBTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
21 Participants25 Participants46 Participants
Age, Continuous30.0 years29.0 years30.0 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)-711.33 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)-913.10 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants5 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants21 Participants37 Participants
Region of Enrollment
United Kingdom
21 participants25 participants46 participants
Sex: Female, Male
Female
12 Participants15 Participants27 Participants
Sex: Female, Male
Male
9 Participants10 Participants19 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDYale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)12 weeks23.47 units on a scaleStandard Deviation 11.23
CBT Specific for BDDYale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)1 month21.37 units on a scaleStandard Deviation 12.42
Non Specific CBTYale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)12 weeks32.87 units on a scaleStandard Deviation 7.45
Non Specific CBTYale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)1 month33.30 units on a scaleStandard Deviation 8.72
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.p-value: <0.001Mixed Models Analysis
Comparison: Investigating the difference in BDD YBOCS score between baseline and week 12p-value: <0.001t-test, 2 sided
Comparison: Investigating the difference in BDD YBOCS score between between baseline and 1 month follow upp-value: <0.001t-test, 2 sided
Comparison: Investigating the difference in BDD YBOCS score between baseline and week 12p-value: <0.01t-test, 2 sided
Comparison: Investigating the difference in BDD YBOCS score between baseline and 1 month follow upp-value: <0.05t-test, 2 sided
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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDAppearance Anxiety Inventory (AAI)12 week14.61 units on a scaleStandard Deviation 9.2
CBT Specific for BDDAppearance Anxiety Inventory (AAI)1 month14.16 units on a scaleStandard Deviation 9.53
Non Specific CBTAppearance Anxiety Inventory (AAI)12 week23.37 units on a scaleStandard Deviation 8.29
Non Specific CBTAppearance Anxiety Inventory (AAI)1 month23.21 units on a scaleStandard Deviation 8.86
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.p-value: <0.05Mixed Models Analysis
Comparison: Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .p-value: <0.001t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.p-value: <0.001t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .p-value: <0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.p-value: >0.05t-test, 2 sided
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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDBody Image Quality of Life Inventory (BIQLI)12 week-1.43 units on a scaleStandard Deviation 0.85
CBT Specific for BDDBody Image Quality of Life Inventory (BIQLI)1 month-1.29 units on a scaleStandard Deviation 0.92
Non Specific CBTBody Image Quality of Life Inventory (BIQLI)12 week-2.04 units on a scaleStandard Deviation 0.71
Non Specific CBTBody Image Quality of Life Inventory (BIQLI)1 month-1.95 units on a scaleStandard Deviation 0.81
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.p-value: <0.05Mixed Models Analysis
Comparison: Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).p-value: <0.05t-test, 2 sided
Comparison: Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.p-value: <0.05t-test, 2 sided
Comparison: Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).p-value: >0.05t-test, 2 sided
Comparison: Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.p-value: >0.05t-test, 2 sided
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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDBrown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)12 week12.75 units on a scaleStandard Deviation 8.11
CBT Specific for BDDBrown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)1 month10.28 units on a scaleStandard Deviation 7.41
Non Specific CBTBrown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)12 week17.92 units on a scaleStandard Deviation 5.42
Non Specific CBTBrown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)1 month18.88 units on a scaleStandard Deviation 4.62
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.p-value: <0.05Mixed Models Analysis
Comparison: T-tests were used to investigate significant differences between baseline and 12 week measuresp-value: <0.01t-test, 2 sided
Comparison: T-tests were used to investigate significant differences between baseline and 1 month follow up.p-value: <0.001t-test, 2 sided
Comparison: T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.p-value: >0.05t-test, 2 sided
Comparison: T-tests were used to investigate significant differences between baseline and 1 month follow up measures.p-value: >0.05t-test, 2 sided
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.

Time frame: 12 weeks,1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDGeneralised Anxiety Disorder (GAD)-712 week7.00 units on a scaleStandard Deviation 6.02
CBT Specific for BDDGeneralised Anxiety Disorder (GAD)-71 month8.53 units on a scaleStandard Deviation 6.6
Non Specific CBTGeneralised Anxiety Disorder (GAD)-712 week11.59 units on a scaleStandard Deviation 5.89
Non Specific CBTGeneralised Anxiety Disorder (GAD)-71 month13.22 units on a scaleStandard Deviation 5.45
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.p-value: <0.05Mixed Models Analysis
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.p-value: <0.01t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.p-value: >0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.p-value: >0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.p-value: >0.05t-test, 2 sided
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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDMontgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).12 week21.71 units on a scaleStandard Deviation 11.2
CBT Specific for BDDMontgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).1 month20.40 units on a scaleStandard Deviation 13.14
Non Specific CBTMontgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).12 week25.98 units on a scaleStandard Deviation 10.8
Non Specific CBTMontgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).1 month28.63 units on a scaleStandard Deviation 13.32
Comparison: A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.p-value: >0.05Mixed Models Analysis
Comparison: Investigating the difference in MADRS score between baseline and week 12.p-value: <0.01t-test, 2 sided
Comparison: Investigating the difference in MADRS score between baseline and 1 month follow up.p-value: >0.05t-test, 2 sided
Comparison: Investigating the difference in MADRS score between baseline and week 12.p-value: >0.05t-test, 2 sided
Comparison: Investigating the difference in MADRS score between baseline and 1 month follow up.p-value: >0.05t-test, 2 sided
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.

Time frame: 12 weeks, 1 month post treatment

ArmMeasureGroupValue (MEAN)Dispersion
CBT Specific for BDDPatient Health Questionnaire (PHQ)-912 week9.12 units on a scaleStandard Deviation 7.01
CBT Specific for BDDPatient Health Questionnaire (PHQ)-91 month9.41 units on a scaleStandard Deviation 6.67
Non Specific CBTPatient Health Questionnaire (PHQ)-912 week13.28 units on a scaleStandard Deviation 7.18
Non Specific CBTPatient Health Questionnaire (PHQ)-91 month15.79 units on a scaleStandard Deviation 7.05
Comparison: Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.p-value: >0.05Mixed Models Analysis
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).p-value: <0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.p-value: >0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).p-value: >0.05t-test, 2 sided
Comparison: Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.p-value: >0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026