Body Dysmorphic DisorderNCT01453439
Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
A study testing Cognitive Behavioral Therapy and Supportive Psychotherapy in people with Body Dysmorphic Disorder and Obsessive-Compulsive Spectrum Disorder, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to learn more about two different types of psychotherapy to help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and common disorder consisting of distressing or impairing preoccupation with perceived defects in one's physical appearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorder, Obsessive-Compulsive Spectrum Disorder, Anxiety Disorders
- What is being tested?
- Cognitive Behavioral Therapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to 7 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient men and women age 18 and older
- DSM-IV BDD or its delusional variant for at least 6 months
- BDD is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
- Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
Who cannot join
- Current clinically significant suicidality and/or score on the BDI-II suicide item (#9) > 1
- Any clinical features requiring a higher level of care
- Mental retardation or borderline intellectual functioning (estimated IQ < 80 on the Wechsler Abbreviated Scale of Intelligence) or dementia, brain damage, or other cognitive impairment that would interfere with ability to engage in CBT
- DSM-IV substance abuse or dependence within the past 3 months; or a positive urine drug screen for any illicit substances of abuse
- Current manic episode
- Psychotic disorder
Show all 12Show fewer
- Borderline personality disorder
- Body image concerns accounted for by an eating disorder
- Previous treatment with > 10 sessions of CBT for BDD
- Subjects cannot be receiving any other psychotherapy or begin such treatment during the study
- Patients can be receiving psychotropic medication if they have taken a stable dose for at least two months before the study baseline assessment and the dose remains stable during the study.
- Presence of any behavior (e.g., violence) that would interfere with full cooperation with the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder
The purpose of this study is to learn more about two different types of psychotherapy to help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and common disorder consisting of distressing or impairing preoccupation with perceived defects in one's physical appearance. Individuals with BDD have very poor psychosocial functioning and high rates of hospitalization and suicidality. Because BDD differs in important ways from other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy and Supportive Psychotherapy as well as predictors of improvement.
Read the detailed description
Body Dysmorphic Disorder (BDD) is a common and severe disorder in which a person is preoccupied by perceived defects in his or her appearance. The purpose of this research study is to learn more about two different forms of therapy to help individuals with BDD: cognitive behavioral therapy (CBT), a promising new treatment for BDD, and supportive psychotherapy (SPT), the most commonly received therapy for BDD. The investigators would like to find out which treatment is more effective for BDD. The investigators will also examine patient characteristics that may predict response to treatment.
Participants will be randomly assigned (like the flip of a coin) to receive 22 sessions (over 24 weeks) of either CBT or SPT. Both treatments teach participants about BDD. CBT focuses on helping participants to develop more adaptive thoughts and beliefs and to gradually reduce avoidance and compulsive (repetitive) behaviors. SPT focuses on relationships, feelings, and other factors that may affect BDD symptoms (e.g., work, stress), and helps participants to cope with challenges in their life by improving self-esteem and positive coping.
For each participant, this study will last for 12 months. CBT and SPT sessions occur for 22 sessions over 24 weeks. The severity of participants' BDD-related symptoms and other symptoms will be assessed at the end of treatment (week 24), and at 3- and 6-months after treatment ends.
- Conditions
- Body Dysmorphic Disorder, Obsessive-Compulsive Spectrum Disorder, Anxiety Disorders, Somatoform Disorders
- Being tested
- Cognitive Behavioral Therapy, Supportive Psychotherapy
- Keywords
- Body dysmorphic disorder, Obsessive compulsive spectrum disorder, Body image, Appearance concerns
- Medical subject headings
- Body Dysmorphic Disorders, Anxiety Disorders, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based CBT. During the sessions, participants will receive education about BDD and CBT, learn to develop more helpful thoughts and beliefs, gradually enter anxiety provoking situations while reducing compulsions (repetitive behaviors), and learn relapse prevention techniques.
Supportive PsychotherapyBehavioural
Also called SPT
Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based SPT. During the sessions, participants will receive education about BDD and SPT, learn about factors that may affect their symptoms (for example, relationships, work, stress), and learn to cope with challenges in their life by improving self-esteem and positive coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Group receiving Cognitive-Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Supportive Psychotherapy | Active comparator | Group receiving Supportive Psychotherapy Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Measured: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.
Secondary outcomes (10)
Insight Regarding BDD Beliefs (as Measured by the BABS)
The Brown Assessment of Beliefs Scale (BABS) is a 7-item, semi-structured, clinician-administered measure that was used to assess insight regarding BDD-related beliefs (e.g., "I look deformed"). The first six items of the BABS were summed to obtain a total score ranging from 0 to 24, with higher scores reflecting poorer insight. Treatment effects on BABS score were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Measured: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
Depressive Symptoms (as Measured by the BDI-II)
The Beck Depression Inventory-Second Edition (BDI-II) is a widely used 21-item self-report scale that assesses the severity of depressive symptoms during the past 2 weeks. Total scale scores range from 0 to 63, with higher scores indicating greater symptom severity. Treatment effects on depression were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Measured: Measured every week during treatment, but analysis was performed only on BDI-II assessments close to assessment visits; wk 0, 4, 8, 12, 16, 20 and 24. Followup phase data was measured at week 37 and week 50.
Life Satisfaction (Q-LESQ-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Questions 1-14 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the % score range is 0% to 100%, with higher scores indicating greater quality of life. Treatment effects on life satisfaction were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Measured: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.
Treatment Credibility (Credibility/Expectancy Rating Scale)
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment credibility is based on the mean score of the first three items, which are measured on 10-point Likert scales, so that mean scores range from 1 (lowest/worst) to 10 (highest/most). Treatment credibility was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Measured: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Beliefs About Appearance (as Measured by the ASI-R)
Measured: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Neuropsychological Functioning (as Measured by the ROCF)
Measured: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Information Processing (as Measured by the ERT)
Measured: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) is a 5-item self-report measure of functional impairment/disability. Items 1-3 (disability in work, social life/leisure, and family life/home responsibilities, respectively) are scored on Likert-scales that range from 0 (not at all) to 10 (extreme). The three items are then summed to yield an SDS total score, ranging from 0 (unimpaired) to 30 (highly impaired). Treatment effects on functional impairment were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Measured: Measured at baseline, week 4, week 12, week 16, and week 24. Follow-up phase data was measured at week 37 and at week 50.
Treatment Satisfaction (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire that assesses satisfaction with clinical services received and has a score range of 8-32, where higher scores indicate higher satisfaction.
Measured: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
Treatment Expectancy (Credibility/Expectancy Rating Scale)
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment expectancy is a single item rating of "By the end of therapy, how much improvement in your anxiety do you think will occur?", rated on a scale from 0% to 100%. It was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Measured: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startAug 2011
- Primary completion5 Jan 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, Ph.D., Principal investigator, Massachusetts General HospitalKatharine Phillips, M.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453439
- Sponsor's protocol ID
- R01MH091078
- Other IDs
- R01MH091078, 2010-P-001021/2
- Status last verified
- Jul 2020
- First submitted
- 30 Aug 2011
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wilhelm S, Phillips KA, Greenberg JL, O'Keefe SM, Hoeppner SS, Keshaviah A, Sarvode-Mothi S, Schoenfeld DA. Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults With Body Dysmorphic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Apr 1;76(4):363-373. doi: 10.1001/jamapsychiatry.2018.4156.
PubMed 30785624
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT Versus Supportive Psychotherapy for Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT01453439
- Acronym / sponsor ID
- R01MH091078
- Conditions
- Body Dysmorphic Disorder, Obsessive-Compulsive Spectrum Disorder, Anxiety Disorders, Somatoform Disorders
- Keywords
- Body dysmorphic disorder, Obsessive compulsive spectrum disorder, Body image, Appearance concerns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2011
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about two different types of psychotherapy to help individuals who have body dysmorphic disorder (BDD). BDD is a severe, often chronic, and common disorder consisting of distressing or impairing preoccupation with perceived defects in one's physical appearance. Individuals with BDD have very poor psychosocial functioning and high rates of hospitalization and suicidality. Because BDD differs in important ways from other disorders, psychotherapies for other disorders are not adequate for BDD. Despite BDD's severity, there is no adequately tested psychosocial treatment (psychotherapy) of any type for this disorder. This study will compare the effectiveness of Cognitive Behavioral Therapy and Supportive Psychotherapy as well as predictors of improvement.
Detailed description
Body Dysmorphic Disorder (BDD) is a common and severe disorder in which a person is preoccupied by perceived defects in his or her appearance. The purpose of this research study is to learn more about two different forms of therapy to help individuals with BDD: cognitive behavioral therapy (CBT), a promising new treatment for BDD, and supportive psychotherapy (SPT), the most commonly received therapy for BDD. The investigators would like to find out which treatment is more effective for BDD. The investigators will also examine patient characteristics that may predict response to treatment.
Participants will be randomly assigned (like the flip of a coin) to receive 22 sessions (over 24 weeks) of either CBT or SPT. Both treatments teach participants about BDD. CBT focuses on helping participants to develop more adaptive thoughts and beliefs and to gradually reduce avoidance and compulsive (repetitive) behaviors. SPT focuses on relationships, feelings, and other factors that may affect BDD symptoms (e.g., work, stress), and helps participants to cope with challenges in their life by improving self-esteem and positive coping.
For each participant, this study will last for 12 months. CBT and SPT sessions occur for 22 sessions over 24 weeks. The severity of participants' BDD-related symptoms and other symptoms will be assessed at the end of treatment (week 24), and at 3- and 6-months after treatment ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyGroup receiving Cognitive-Behavioral Therapy |
| Supportive Psychotherapy | Active comparator | Behavioral: Supportive PsychotherapyGroup receiving Supportive Psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient men and women age 18 and older
- DSM-IV BDD or its delusional variant for at least 6 months
- BDD is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
- Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
Key exclusion criteria (12 listed)
- Current clinically significant suicidality and/or score on the BDI-II suicide item (#9) > 1
- Any clinical features requiring a higher level of care
- Mental retardation or borderline intellectual functioning (estimated IQ < 80 on the Wechsler Abbreviated Scale of Intelligence) or dementia, brain damage, or other cognitive impairment that would interfere with ability to engage in CBT
- DSM-IV substance abuse or dependence within the past 3 months; or a positive urine drug screen for any illicit substances of abuse
- Current manic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTParticipants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based CBT. During the sessions, participants will receive education about BDD and CBT, learn to develop more helpful thoughts and beliefs, gradually enter anxiety provoking situations while reducing compulsions (repetitive behaviors), and learn relapse prevention techniques. | Behavioural | Cognitive Behavioral Therapy |
| Supportive PsychotherapyAlso: SPTParticipants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based SPT. During the sessions, participants will receive education about BDD and SPT, learn about factors that may affect their symptoms (for example, relationships, work, stress), and learn to cope with challenges in their life by improving self-esteem and positive coping skills. | Behavioural | Supportive Psychotherapy |
Primary outcome
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Time frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
10 secondary outcomes
Insight Regarding BDD Beliefs (as Measured by the BABS)
Time frame: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visits
Depressive Symptoms (as Measured by the BDI-II)
Time frame: Measured every week during treatment, but analysis was performed only on BDI-II assessments close to assessment visits; wk 0, 4, 8, 12, 16, 20 and 24. Followup phase data was measured at week 37 and week 50.
Life Satisfaction (Q-LESQ-SF)
Time frame: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.
Treatment Credibility (Credibility/Expectancy Rating Scale)
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Beliefs About Appearance (as Measured by the ASI-R)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Neuropsychological Functioning (as Measured by the ROCF)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Information Processing (as Measured by the ERT)
Time frame: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])
Sheehan Disability Scale (SDS)
Time frame: Measured at baseline, week 4, week 12, week 16, and week 24. Follow-up phase data was measured at week 37 and at week 50.
Treatment Satisfaction (CSQ-8)
Time frame: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]
Treatment Expectancy (Credibility/Expectancy Rating Scale)
Time frame: Measured twice during the study (week 0 [pre-treatment] and at week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30785624Wilhelm S, Phillips KA, Greenberg JL, O'Keefe SM, Hoeppner SS, Keshaviah A, Sarvode-Mothi S, Schoenfeld DA. Efficacy and Posttreatment Effects of Therapist-Delivered Cognitive Behavioral Therapy vs Supportive Psychotherapy for Adults With Body Dysmorphic Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Apr 1;76(4):363-373. doi: 10.1001/jamapsychiatry.2018.4156.
- Click here to visit the official website of the Body Dysmorphic Disorder Clinic at MGHLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Wilhelm, Ph.D. principal investigator
Massachusetts General Hospital
Katharine Phillips, M.D. principal investigator
Rhode Island Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Supportive Psychotherapy in people with Body Dysmorphic Disorder and Obsessive-Compulsive Spectrum Disorder, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS) (time frame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01453439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.