Borderline Personality DisorderCPTDBTNCT02574429
CPT Group for DBT Clients With Co-Occurring Borderline Personality Disorder and PTSD
A study testing Cognitive Processing Therapy in people with Borderline Personality Disorder and Posttraumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
Trial summary
Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals diagnosed with co-occurring BPD/PTSD who are either currently participating in Standard Dialectical Behaviour Therapy (DBT) or who have completed DBT
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3K7
St Joseph's Healthcare Hamilton, Community Psychiatry Clinic
Hamilton, Ontario, L8N3K7
About this study
Official title: Pilot Study Examining the Impact of a Cognitive Processing Therapy (CPT) Group for Patients With Co-Occurring Borderline Personality Disorder and Posttraumatic Stress Disorder
Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.
Read the detailed description
Borderline personality disorder (BPD) is a severe psychological disorder characterized by instability in emotion regulation, interpersonal relationships, and self-image, coupled with marked impulsivity. Additionally, individuals with BPD often meet criteria for other disorders. One of the most commonly co-occurring disorders among individuals diagnosed with BPD is posttraumatic stress disorder (PTSD). Within this population, 56% to 58% of inpatients, and between 36% to 50% of outpatients are diagnosed with co-occurring PTSD.
The high prevalence of this co-occurrence is consistent with studies documenting the severe traumatic experiences (including, but not limited to, physical, sexual, and emotional abuse, both as children and adults) commonly experienced by individuals diagnosed with BPD . Additionally, risk factors for PTSD identified by meta-analyses share striking commonalities with those of BPD, including: lack of social support, prior history of trauma (including childhood abuse), and poor psychological adjustment prior to trauma.
The co-occurrence of BPD/PTSD is associated with poorer outcomes and significant distress than the presence of either disorder alone. For example, individuals with co-occurring BPD/PTSD exhibit a lower likelihood of remission from BPD after 10 years of follow-up, and are also more likely to engage in non-suicidal self-injurious behavior (NSSI). In addition, BPD patients diagnosed with PTSD are also faced with greater emotional dysfunction and global psychological distress, as well as inferior physical health compared to individuals with BPD alone.
Several studies have proposed theories on the high co-occurrence of these disorders, but few have investigated potential treatments to address the unique issues associated with this comorbidity. The current standard of treatment for BPD, Dialectical Behaviour Therapy (DBT), has a solid empirical basis, including numerous randomized control trials (RCTs) demonstrating its efficacy in the reduction of associated symptoms. Despite the efficacy of DBT, the DBT treatment manual (Linehan, 1993) did not outline a specific protocol for intervention in patients with co-occurring BPD and PTSD. Moreover, outcomes from DBT trials indicate that DBT alone does not adequately treat co-occurring BPD/PTSD. Specifically, data from an RCT evaluating DBT in suicidal women with BPD demonstrated that only 13% of patients diagnosed with BPD/PTSD achieved full remission from PTSD during one year of DBT.
Recently, researchers have focused on identifying how to treat individuals with BPD and PTSD within the context of DBT. Harned and colleagues have developed and tested a combined DBT PE protocol that has shown efficacy in treating BPD/PTSD. This combined treatment addresses some of the problems inherent in the direct application of the conventional PTSD treatment, prolonged exposure (PE) therapy for individuals with BPD. Evaluations of PE show that PE significantly reduces PTSD symptoms and secondary outcomes such as depression. PE is designed to counteract avoidance of traumatic memories through repeated exposure to the traumatic memory, as well as in vivo exposure to non-dangerous events perceived to be fearful by the patient. The intention of the treatment is to alleviate overestimation of the likelihood and severity of negative outcomes, as well as conditioned fear responses to certain situations, often experienced by PTSD patients.
Several characteristics of individuals with BPD interfere with the ability to engage in emotional exposure, the central intervention of PE therapy. These may include: self-injurious behaviours, other co-occurring issues (e.g. dissociation, substance use, ongoing trauma), emotional dysregulation (over-engagement, under-engagement, and strong non-fear emotions), trauma memory characteristics (large quantity and/or poor quality of trauma memories), and treatment noncompliance. The combined DBT protocol includes specific strategies to address these problems. While this combined DBT/PE protocol is an important step towards addressing the gap in treatment for individuals with co-occurring BPD/PTSD, there are other evidenced-based interventions that also merit evaluation in a combined DBT/PTSD treatment, notably Cognitive Processing Therapy (CPT).
Like PE, CPT has a strong evidence base to support its effectiveness treating PTSD. The protocol for CPT was initially generated as a treatment for victims of sexual assault and has since been successfully used to treat other types of trauma . It consists of cognitive therapy focused on how the traumatic event has impacted the individual's beliefs about themselves, others, and the world in general. The treatment involves 12 sessions of therapy, along with homework between sessions. The objective of the treatment is to first help patients identify dysfunctional beliefs and assumptions stemming from the traumatic experiences, challenge these beliefs (i.e., "stuck points", and then develop new beliefs reflecting a broader perspective.
While combined DBT/PE treatment is encouraging, CPT may have benefits that are similar to, if not superior to PE in some ways. Research on CPT indicates that treatment is similarly effective to PE in reducing PTSD symptoms and depression. However, their respective impact on secondary symptoms may differ due to the different mechanisms underlying each treatment. For example, one study suggested that CPT may be superior to PE on specific scales of guilt. One distinct benefit of CPT is that it is available and efficacious in both individual and group formats, whereas PE is available only individually. Group CPT allows efficient use of resources, which is critical in the context of a publicly funded health-system. In light of the fact that Standard DBT requires extensive clinician resources, the efficient use of supplementary treatments is even more critical. Finally, there may be other benefits to group that warrant research, including reduction of stigma of PTSD and associated shame by addressing this within a group context.
This study aims to assess the efficacy of CPT to address PTSD symptoms among individuals with co-occurring BPD/PTSD who are participating in Standard DBT. It is hypothesized that individuals will show significant reductions in primary symptom outcomes (PTSD) and secondary symptom outcomes (e.g., BPD symptoms, shame, anxiety, depression) between pre and post- treatment. This study aims to provide one of the first clinical examinations of the effectiveness of CPT as a treatment for co-occurring BPD and PTSD among individuals participating in Standard DBT. The results of such a trial could not only lead to the establishment a potentially clinically effective and cost-effective alternative to PE in this population, but also further elucidate the mechanism behind this complex comorbidity.
- Being tested
- Cognitive Processing Therapy
- Keywords
- Borderline Personality Disorder, Posttraumatic Stress Disorder, Cognitive Processing Therapy, Group Therapy, Comorbidity, Dialectical Behavior Therapy
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT
Cognitive Processing Therapy is an evidenced-based treatment for PTSD. The investigators are offering CPT group over 13 weeks (12 group sessions \& 1 individual session). CPT focuses on challenging beliefs that developed or were reinforced following the trauma(s).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy | Experimental | Individuals who have either completed Standard Dialectical Behavior Therapy (DBT) for Borderline Personality Disorder (BPD) and/or are currently enrolled in DBT who have co-occuring PTSD. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Self-report measure assessing change in PTSD DSM-5 symptoms are affecting the participant. The investigators are comparing pre-PCL scores to post-PCL scores. In addition, the investigators are interested in examing the pattern of change between sessions.
Measured: Weekly for 13 weeks (course of treatment)
Secondary outcomes (9)
BSL-23
Self-report measure assessing the presence of BPD symptoms (experiences and behaviors)
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Ways of Coping Checklist (WCCL)
Self-reported use of DBT skills use vs. less effective ways of coping
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Depression, Anxiety, Stress and Suicide Scale (DASS-21)
Self-report measure assessing symptoms of depression, anxiety, stress and suicide.
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Difficulties in Emotion Regulation Scale (DERS)
Self-report measure assessing how the individual expresses and copes with emotions
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Experience of Shame Scale
Self-report measure assessing the extent that an individual experienced shame
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Anxiety Sensitivity Index (ASI-3)
Self-report measure assessing the extent to which an individual is sensitive to anxiety cues
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Self-compassion Scale (SCS)
Self-report measure assessing the extent to which an individual treats his or herself self-compassionately.
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
The Life Events Checklist for DSM-5 (LEC-5)
Self-reported description of the nature of the traumatic experience(s) the individual experienced.
Measured: Baseline only
Borderline Evaluation of Severity Overtime (BEST)
Self-report measure assessing the presence of BPD symptoms (experiences and behaviors)
Measured: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574429
- Sponsor's protocol ID
- CPTDBT-1
- Acronym
- CPTDBT
- Status last verified
- Dec 2018
- First submitted
- 18 Sep 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Examining the Impact of a Cognitive Processing Therapy (CPT) Group for Patients With Co-Occurring Borderline Personality Disorder and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02574429
- Acronym / sponsor ID
- CPTDBT / CPTDBT-1
- Keywords
- Borderline Personality Disorder, Posttraumatic Stress Disorder, Cognitive Processing Therapy, Group Therapy, Comorbidity, Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.
Detailed description
Borderline personality disorder (BPD) is a severe psychological disorder characterized by instability in emotion regulation, interpersonal relationships, and self-image, coupled with marked impulsivity. Additionally, individuals with BPD often meet criteria for other disorders. One of the most commonly co-occurring disorders among individuals diagnosed with BPD is posttraumatic stress disorder (PTSD). Within this population, 56% to 58% of inpatients, and between 36% to 50% of outpatients are diagnosed with co-occurring PTSD.
The high prevalence of this co-occurrence is consistent with studies documenting the severe traumatic experiences (including, but not limited to, physical, sexual, and emotional abuse, both as children and adults) commonly experienced by individuals diagnosed with BPD . Additionally, risk factors for PTSD identified by meta-analyses share striking commonalities with those of BPD, including: lack of social support, prior history of trauma (including childhood abuse), and poor psychological adjustment prior to trauma.
The co-occurrence of BPD/PTSD is associated with poorer outcomes and significant distress than the presence of either disorder alone. For example, individuals with co-occurring BPD/PTSD exhibit a lower likelihood of remission from BPD after 10 years of follow-up, and are also more likely to engage in non-suicidal self-injurious behavior (NSSI). In addition, BPD patients diagnosed with PTSD are also faced with greater emotional dysfunction and global psychological distress, as well as inferior physical health compared to individuals with BPD alone.
Several studies have proposed theories on the high co-occurrence of these disorders, but few have investigated potential treatments to address the unique issues associated with this comorbidity. The current standard of treatment for BPD, Dialectical Behaviour Therapy (DBT), has a solid empirical basis, including numerous randomized control trials (RCTs) demonstrating its efficacy in the reduction of associated symptoms. Despite the efficacy of DBT, the DBT treatment manual (Linehan, 1993) did not outline a specific protocol for intervention in patients with co-occurring BPD and PTSD. Moreover, outcomes from DBT trials indicate that DBT alone does not adequately treat co-occurring BPD/PTSD. Specifically, data from an RCT evaluating DBT in suicidal women with BPD demonstrated that only 13% of patients diagnosed with BPD/PTSD achieved full remission from PTSD during one year of DBT.
Recently, researchers have focused on identifying how to treat individuals with BPD and PTSD within the context of DBT. Harned and colleagues have developed and tested a combined DBT PE protocol that has shown efficacy in treating BPD/PTSD. This combined treatment addresses some of the problems inherent in the direct application of the conventional PTSD treatment, prolonged exposure (PE) therapy for individuals with BPD. Evaluations of PE show that PE significantly reduces PTSD symptoms and secondary outcomes such as depression. PE is designed to counteract avoidance of traumatic memories through repeated exposure to the traumatic memory, as well as in vivo exposure to non-dangerous events perceived to be fearful by the patient. The intention of the treatment is to alleviate overestimation of the likelihood and severity of negative outcomes, as well as conditioned fear responses to certain situations, often experienced by PTSD patients.
Several characteristics of individuals with BPD interfere with the ability to engage in emotional exposure, the central intervention of PE therapy. These may include: self-injurious behaviours, other co-occurring issues (e.g. dissociation, substance use, ongoing trauma), emotional dysregulation (over-engagement, under-engagement, and strong non-fear emotions), trauma memory characteristics (large quantity and/or poor quality of trauma memories), and treatment noncompliance. The combined DBT protocol includes specific strategies to address these problems. While this combined DBT/PE protocol is an important step towards addressing the gap in treatment for individuals with co-occurring BPD/PTSD, there are other evidenced-based interventions that also merit evaluation in a combined DBT/PTSD treatment, notably Cognitive Processing Therapy (CPT).
Like PE, CPT has a strong evidence base to support its effectiveness treating PTSD. The protocol for CPT was initially generated as a treatment for victims of sexual assault and has since been successfully used to treat other types of trauma . It consists of cognitive therapy focused on how the traumatic event has impacted the individual's beliefs about themselves, others, and the world in general. The treatment involves 12 sessions of therapy, along with homework between sessions. The objective of the treatment is to first help patients identify dysfunctional beliefs and assumptions stemming from the traumatic experiences, challenge these beliefs (i.e., "stuck points", and then develop new beliefs reflecting a broader perspective.
While combined DBT/PE treatment is encouraging, CPT may have benefits that are similar to, if not superior to PE in some ways. Research on CPT indicates that treatment is similarly effective to PE in reducing PTSD symptoms and depression. However, their respective impact on secondary symptoms may differ due to the different mechanisms underlying each treatment. For example, one study suggested that CPT may be superior to PE on specific scales of guilt. One distinct benefit of CPT is that it is available and efficacious in both individual and group formats, whereas PE is available only individually. Group CPT allows efficient use of resources, which is critical in the context of a publicly funded health-system. In light of the fact that Standard DBT requires extensive clinician resources, the efficient use of supplementary treatments is even more critical. Finally, there may be other benefits to group that warrant research, including reduction of stigma of PTSD and associated shame by addressing this within a group context.
This study aims to assess the efficacy of CPT to address PTSD symptoms among individuals with co-occurring BPD/PTSD who are participating in Standard DBT. It is hypothesized that individuals will show significant reductions in primary symptom outcomes (PTSD) and secondary symptom outcomes (e.g., BPD symptoms, shame, anxiety, depression) between pre and post- treatment. This study aims to provide one of the first clinical examinations of the effectiveness of CPT as a treatment for co-occurring BPD and PTSD among individuals participating in Standard DBT. The results of such a trial could not only lead to the establishment a potentially clinically effective and cost-effective alternative to PE in this population, but also further elucidate the mechanism behind this complex comorbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing TherapyIndividuals who have either completed Standard Dialectical Behavior Therapy (DBT) for Borderline Personality Disorder (BPD) and/or are currently enrolled in DBT who have co-occuring PTSD. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with co-occurring BPD/PTSD who are either currently participating in Standard Dialectical Behaviour Therapy (DBT) or who have completed DBT
Key exclusion criteria (1 listed)
- -
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 Processing TherapyAlso: CPTCognitive Processing Therapy is an evidenced-based treatment for PTSD. The investigators are offering CPT group over 13 weeks (12 group sessions \& 1 individual session). CPT focuses on challenging beliefs that developed or were reinforced following the trauma(s). | Behavioural | Cognitive Processing Therapy |
Primary outcome
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Weekly for 13 weeks (course of treatment)
Self-report measure assessing change in PTSD DSM-5 symptoms are affecting the participant. The investigators are comparing pre-PCL scores to post-PCL scores. In addition, the investigators are interested in examing the pattern of change between sessions.
9 secondary outcomes
BSL-23
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Ways of Coping Checklist (WCCL)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Depression, Anxiety, Stress and Suicide Scale (DASS-21)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Experience of Shame Scale
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Anxiety Sensitivity Index (ASI-3)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Self-compassion Scale (SCS)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
The Life Events Checklist for DSM-5 (LEC-5)
Time frame: Baseline only
Borderline Evaluation of Severity Overtime (BEST)
Time frame: 2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Processing Therapy in people with Borderline Personality Disorder and Posttraumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
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 1 inclusion and 1 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 19 Dec 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) (time frame: Weekly for 13 weeks (course of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2018.