InsomniaRESTNCT02120989
Researching Effective Sleep Treatments (Project REST)
A study testing Partner-Assisted Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of California, San Diego at 1 site in United States.
Trial summary
We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Partner-Assisted Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Meet diagnostic criteria for insomnia, including a score of 8 or higher on the Insomnia Severity Index (ISI)
- Stable bed partner (i.e., someone with whom they have lived for at least one month prior to the screening appointment and someone who they anticipate to continue living with for the next two months while in the study treatment) who can commit to participating in patient's insomnia treatment. Patients and bed partners who sleep in different beds are eligible to participate.
- English literacy
- Participation in the group Partner-Assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) class
Who cannot join
- A score of 7 or lower on the Insomnia Severity Index (ISI)
- Unmanaged psychosis or manic episodes in the past two months. For any interested potential participants with a history of bipolar disorder, their bipolar disorder must be stable (i.e., euthymic) for two months in order to be eligible to participate.
- Diagnosed (previously or by our study screen) and untreated sleep disorder other than insomnia. Sleep disorders diagnosed, but stably treated (e.g., obstructive sleep apnea treated with CPAP) will be allowed, as long as the treatment is not a hypnotic medication.
- Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
- Current substance use disorder, or meeting criteria for a SUD within the last 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: A Pilot Study Examining the Effectiveness of Partner-Assisted Cognitive Behavioral Therapy for Insomnia
We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact on subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and broader psychiatric functioning.
Read the detailed description
Objective: To investigate whether partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) has a positive impact on subjective and objective sleep and quality of life in individuals with insomnia. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and impact on broader psychiatric functioning.
Research Design: This is an open trial, feasibility study designed to examine the effectiveness of partner-assisted CBT-I on insomnia patient's sleep and quality of life. After individuals, Veterans and non-Veterans, and their respective bed partners consent to participate in this treatment study, we will collect de-identified data including self-report questionnaires, daily sleep diaries, and actigraphy (ambulatory sleep/wake monitoring). For Veteran participants, we also plan to collect data from medical records. Study participants will be seen for study partner-assisted CBT-I treatment at the VA San Diego Healthcare System (VASDHS) Sleep and Mood Clinic. The initial screening appointment and 1-month follow up assessment will be conducted in the Veterans Medical Research Foundation (VMRF) building. The entire study will take two years; participation for Veterans and non-Veterans will last about 3 months from the date of initial screening appointment to their follow up assessment.
Methodology:
Procedures:
Participants will primarily be recruited through the VASDHS's Sleep and Mood Clinic by physician and clinician referrals as well as posted study fliers in these clinics. Non-veterans such as those enrolled in other UCSD research studies will also be recruited. All individuals who meet eligibility criteria will be offered the opportunity to participate and informed consent will be obtained for those who wish to do so. Participation or non-participation in the protocol will not affect clinical care. Assessments of sleep symptoms, health-related quality of life, treatment adherence, relationship satisfaction, and psychiatric functioning will occur as part of standard treatment protocols. Assessments include self-report questionnaires as well as weekly sleep diaries and two weeks of actigraphy (e.g., at the start and end of treatment). Assessment data will be de-identified and analyzed to determine: (a) descriptive characteristics of study participants; (b) effectiveness of partner-assisted CBT-I treatment; (c) relationship functioning; (d) treatment adherence (e.g., did participants follow treatment recommendations from week to week); and, (e) any reduction in symptoms of psychiatric conditions that frequently co-occur with insomnia including mood and/or PTSD symptoms.
Treatment:
We aim to test the effectiveness of partner-assisted CBT-I treatment in patients with insomnia. There are currently no published studies on a couple-based CBT-I approach. The proposed treatment will closely resemble the CBT-I manual currently used for insomnia group therapy in the VA Sleep and Mood Clinic. The main difference will be the inclusion of patients' partners in treatment and administering the manual with emphasis on how patients' partners can assist the patient in making behavioral changes outlined and prioritized in the existing manual.
Data Extraction and Security Plan:
Data will be collected and extracted in a de-identified format and coded only with a study specific number.
- Demographic information: e.g., age, relationship status, era of military service (for Veteran participants), gender, race and ethnicity.
- Treatment information: e.g., number of sessions attended, treatment adherence, treatment barriers.
- Medical / Psychiatric Information: e.g., history of treatment for psychiatric co-morbidities, use of pharmacological agents, and presence of medical conditions.
Statistical Procedures:
- Prior to quantitative analyses, data will be screened to ensure quality and to check standard statistical assumptions.
- Descriptive Statistics will be used to calculate frequency of demographic variables in patients.
- Paired sample t-tests will examine change in pre-treatment and post-treatment means for sleep, quality of life and relationship satisfaction variables.
- Paired sample t-tests will also examine change in post-treatment and follow-up means for sleep, quality of life and relationship satisfaction variables.
- Descriptive Statistics will calculate average weekly treatment adherence from the participant, partner and the therapist perspectives.
- Conditions
- Insomnia
- Being tested
- Partner-Assisted Cognitive Behavioral Therapy for Insomnia
- Keywords
- insomnia, cognitive behavioral therapy for insomnia (CBT-I), partner-assisted
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner-Assisted Cognitive Behavioral Therapy for InsomniaBehavioural
Study treatment includes partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) and consists of 7-8 weekly group therapy sessions of 2 hours each. Partner-assisted CBT-I focuses on altering patients' sleep schedules and changing their behaviors and patterns around sleeping in order to help them sleep in a single block of time overnight. As part of this treatment, participants will be asked to change, possibly reduce, the amount of time spent in bed and to maintain a specific bed time and wake time, as well as other potential changes depending on his/her specific insomnia pattern. This treatment has been shown to be safe and efficacious for a wide range of patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Functioning from Baseline to the End of Treatment
Primary outcome measures (see below for more information about the measures) will assess the change in sleep functioning from baseline to the end of treatment. We will also examine change in sleep functioning from baseline to the 1-month post treatment assessment.
Sleep diaries. Participants will be asked to complete a daily sleep diary throughout the 8 week treatment and one week prior to the 1 month post-treatment follow up appointment. Each morning participants are asked to record sleep habits, such as bedtime, wake time, time in bed, and number and duration of awakenings. Our sleep diary will include questions to track treatment adherence. Sleep diaries are widely used in studies of insomnia.
Questionnaire. Insomnia Severity Index (ISI; Morin et al., 2011). The ISI consists of 7-items that assess severity of insomnia, satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties in the past week.
Measured: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Secondary outcomes (2)
Change in Quality of Life from Baseline to the End of Treatment
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF; Endicott, Nee, Harrison, \& Blumentha, 1993). The Q-LES-Q-SF is a 16-item self-report questionnaire assessing quality of life on multiple domains over the past week including physical and mental health as well as satisfaction with relationships, activities, and overall sense of well being. It has demonstrated good validity.
Measured: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Change in Relationship Functioning from Baseline to the End of Treatment
Dyadic Adjustment Scale (DAS; Spanier, 1976). The DAS is a 32-item inventory of relationship adjustment in couples. It is a widely used measure with sound psychometric properties.
Measured: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Veterans Medical Research Foundation, San Diego Veterans Healthcare System
- Responsible party
- Principal investigator, Sean P.A. Drummond, University of California, San Diego
- Investigators
- Sean PA Drummond, PhD, Principal investigator, VA San Diego Healthcare System and University of California San DiegoMelissa M Jenkins, PhD, Study director, VA San Diego Healthcare System and University of California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120989
- Sponsor's protocol ID
- H140059
- Acronym
- REST
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
PubMed 8037252Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.
PubMed 11772681Perlis, M.L., et al., Cognitive-behavioral therapy for insomnia, in Clinical Handbook of Insomnia. 2004, Springer. p. 155-171.
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PubMed 21532953Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
PubMed 8290681Spanier, G.B., Measuring Dyadic Adjustment: New Scales for Assessing the Quality of Marriage and Similar Dyads. Journal of Marriage and Family, 1976. 38(1): p. 15-28.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Effectiveness of Partner-Assisted Cognitive Behavioral Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT02120989
- Acronym / sponsor ID
- REST / H140059
- Conditions
- Insomnia
- Keywords
- insomnia, cognitive behavioral therapy for insomnia (CBT-I), partner-assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Veterans Medical Research Foundation, San Diego Veterans Healthcare System
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Apr 2014 (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.
We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact on subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and broader psychiatric functioning.
Detailed description
Objective: To investigate whether partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) has a positive impact on subjective and objective sleep and quality of life in individuals with insomnia. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and impact on broader psychiatric functioning.
Research Design: This is an open trial, feasibility study designed to examine the effectiveness of partner-assisted CBT-I on insomnia patient's sleep and quality of life. After individuals, Veterans and non-Veterans, and their respective bed partners consent to participate in this treatment study, we will collect de-identified data including self-report questionnaires, daily sleep diaries, and actigraphy (ambulatory sleep/wake monitoring). For Veteran participants, we also plan to collect data from medical records. Study participants will be seen for study partner-assisted CBT-I treatment at the VA San Diego Healthcare System (VASDHS) Sleep and Mood Clinic. The initial screening appointment and 1-month follow up assessment will be conducted in the Veterans Medical Research Foundation (VMRF) building. The entire study will take two years; participation for Veterans and non-Veterans will last about 3 months from the date of initial screening appointment to their follow up assessment.
Methodology:
Procedures:
Participants will primarily be recruited through the VASDHS's Sleep and Mood Clinic by physician and clinician referrals as well as posted study fliers in these clinics. Non-veterans such as those enrolled in other UCSD research studies will also be recruited. All individuals who meet eligibility criteria will be offered the opportunity to participate and informed consent will be obtained for those who wish to do so. Participation or non-participation in the protocol will not affect clinical care. Assessments of sleep symptoms, health-related quality of life, treatment adherence, relationship satisfaction, and psychiatric functioning will occur as part of standard treatment protocols. Assessments include self-report questionnaires as well as weekly sleep diaries and two weeks of actigraphy (e.g., at the start and end of treatment). Assessment data will be de-identified and analyzed to determine: (a) descriptive characteristics of study participants; (b) effectiveness of partner-assisted CBT-I treatment; (c) relationship functioning; (d) treatment adherence (e.g., did participants follow treatment recommendations from week to week); and, (e) any reduction in symptoms of psychiatric conditions that frequently co-occur with insomnia including mood and/or PTSD symptoms.
Treatment:
We aim to test the effectiveness of partner-assisted CBT-I treatment in patients with insomnia. There are currently no published studies on a couple-based CBT-I approach. The proposed treatment will closely resemble the CBT-I manual currently used for insomnia group therapy in the VA Sleep and Mood Clinic. The main difference will be the inclusion of patients' partners in treatment and administering the manual with emphasis on how patients' partners can assist the patient in making behavioral changes outlined and prioritized in the existing manual.
Data Extraction and Security Plan:
Data will be collected and extracted in a de-identified format and coded only with a study specific number.
- Demographic information: e.g., age, relationship status, era of military service (for Veteran participants), gender, race and ethnicity.
- Treatment information: e.g., number of sessions attended, treatment adherence, treatment barriers.
- Medical / Psychiatric Information: e.g., history of treatment for psychiatric co-morbidities, use of pharmacological agents, and presence of medical conditions.
Statistical Procedures:
- Prior to quantitative analyses, data will be screened to ensure quality and to check standard statistical assumptions.
- Descriptive Statistics will be used to calculate frequency of demographic variables in patients.
- Paired sample t-tests will examine change in pre-treatment and post-treatment means for sleep, quality of life and relationship satisfaction variables.
- Paired sample t-tests will also examine change in post-treatment and follow-up means for sleep, quality of life and relationship satisfaction variables.
- Descriptive Statistics will calculate average weekly treatment adherence from the participant, partner and the therapist perspectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older
- Meet diagnostic criteria for insomnia, including a score of 8 or higher on the Insomnia Severity Index (ISI)
- Stable bed partner (i.e., someone with whom they have lived for at least one month prior to the screening appointment and someone who they anticipate to continue living with for the next two months while in the study treatment) who can commit to participating in patient's insomnia treatment. Patients and bed partners who sleep in different beds are eligible to participate.
- English literacy
- Participation in the group Partner-Assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) class
Key exclusion criteria (5 listed)
- A score of 7 or lower on the Insomnia Severity Index (ISI)
- Unmanaged psychosis or manic episodes in the past two months. For any interested potential participants with a history of bipolar disorder, their bipolar disorder must be stable (i.e., euthymic) for two months in order to be eligible to participate.
- Diagnosed (previously or by our study screen) and untreated sleep disorder other than insomnia. Sleep disorders diagnosed, but stably treated (e.g., obstructive sleep apnea treated with CPAP) will be allowed, as long as the treatment is not a hypnotic medication.
- Severe medical or psychiatric illness that would make it difficult to regularly attend psychotherapy sessions or participate fully in the study
- Current substance use disorder, or meeting criteria for a SUD within the last 90 days
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 |
|---|---|---|
| Partner-Assisted Cognitive Behavioral Therapy for InsomniaStudy treatment includes partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) and consists of 7-8 weekly group therapy sessions of 2 hours each. Partner-assisted CBT-I focuses on altering patients' sleep schedules and changing their behaviors and patterns around sleeping in order to help them sleep in a single block of time overnight. As part of this treatment, participants will be asked to change, possibly reduce, the amount of time spent in bed and to maintain a specific bed time and wake time, as well as other potential changes depending on his/her specific insomnia pattern. This treatment has been shown to be safe and efficacious for a wide range of patients. | Behavioural | – |
Primary outcome
Change in Sleep Functioning from Baseline to the End of Treatment
Time frame: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Primary outcome measures (see below for more information about the measures) will assess the change in sleep functioning from baseline to the end of treatment. We will also examine change in sleep functioning from baseline to the 1-month post treatment assessment. Sleep diaries. Participants will be asked to complete a daily sleep diary throughout the 8 week treatment and one week prior to the 1 month post-treatment follow up appointment. Each morning participants are asked to record sleep habits, such as bedtime, wake time, time in bed, and number and duration of awakenings. Our sleep diary will include questions to track treatment adherence. Sleep diaries are widely used in studies of insomnia. Questionnaire. Insomnia Severity Index (ISI; Morin et al., 2011). The ISI consists of 7-items that assess severity of insomnia, satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties in the past week.
2 secondary outcomes
Change in Quality of Life from Baseline to the End of Treatment
Time frame: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
Change in Relationship Functioning from Baseline to the End of Treatment
Time frame: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up
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 30 Apr 2015.
- Background: PubMed 8037252Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.
- Background: PubMed 11772681Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.
- BackgroundPerlis, M.L., et al., Cognitive-behavioral therapy for insomnia, in Clinical Handbook of Insomnia. 2004, Springer. p. 155-171.
- Background: PubMed 21532953Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
- Background: PubMed 8290681Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
- BackgroundSpanier, G.B., Measuring Dyadic Adjustment: New Scales for Assessing the Quality of Marriage and Similar Dyads. Journal of Marriage and Family, 1976. 38(1): p. 15-28.
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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.
Sean PA Drummond, PhD principal investigator
VA San Diego Healthcare System and University of California San Diego
Melissa M Jenkins, PhD study director
VA San Diego Healthcare System and University of California San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner-Assisted Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of California, San Diego at 1 site 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 5 inclusion and 5 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Change in Sleep Functioning from Baseline to the End of Treatment (time frame: baseline; treatment week 4; week 8 (at end of treatment); 1 month post-treatment follow-up). 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 NCT02120989, which also lists 6 linked publications.
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 30 Apr 2015.