Primary Malignant Brain TumorsSmartCareNCT02058745
SmartCare: Innovations in Caregiving Interventions
A study testing CAU+ (Enhanced Care as Usual), Beating the Blues and SmartCare in people with Primary Malignant Brain Tumors, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Malignant Brain Tumors
- What is being tested?
- CAU+ (Enhanced Care as Usual), Beating the Blues and SmartCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 14 Jun 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Care recipient:
- Over 21 years of age.
- Newly (within 1 month) diagnosed with a PMBT (tumor verified via pathology report to be a glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, medulloblastoma, or anaplastic ependymoma).
- Caregiver:
- Primary nonprofessional, non-paid caregiver, as identified by the care recipient.
- Over 21 years of age with telephone access.
Show all 9Show fewer
- Reads-speaks English
- Obtains a score of >6 on the shortened CES-D.
- Caregivers may or may not be receiving pharmacotherapy for depressive symptoms
Who cannot join
- Caregiver:
- Currently considers self to be a primary caregiver for anyone else other than children
- Currently receiving any type of formal counselling for depressive symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
Read the detailed description
We have designed a needs-based intervention to improve neuro-oncology caregivers' health. Our novel approach treats depressive symptoms prior to implementing a needs-based intervention in a sample of PMBT family caregivers who score above threshold on depressive symptoms. Study outcomes are psychological responses (unmet needs, depressive symptoms, anxiety, and burden) and physical responses (levels of stimulated and circulating IL-6 and IL-1β, C-reactive protein, peripheral blood mono-nuclear cells, physical symptoms, and new diagnoses or exacerbations of co-morbid conditions). The proposed study addresses research priorities set by both NCI and NINR to improve the quality of life of patients and their families and NINR's emphasis on integrating bio-behavioral science and adopting, adapting and generating new technologies.
Primary aims:
- Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues) delivered prior to a needs-based caregiver intervention (SmartCare©) versus b) SmartCare© alone versus c) enhanced care as usual (CAU+) in improving caregivers' psychological and physical responses. H1: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to caregivers who receive CAU+. H2: At 4- and 6-months, caregivers who receive SmartCare© alone will display improved psychological and physical responses compared to caregivers who receive CAU+. H3: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to those who receive SmartCare© alone.
- Compare the efficacy of Beating the Blues versus CAU+ in improving subjects' short-term psychological and physical responses.
H1: At 2-months following baseline, caregivers who receive Beating the Blues will display improved psychological and physical responses compared to CAU+.
Exploratory aims:
- Determine whether any changes in psychological and physical health resulting from receiving Beating the Blues prior to SmartCare© or SmartCare© alone are maintained at 10-months after baseline.
- Evaluate whether the effect of Beating the Blues + SmartCare© (vs. SmartCare© alone) on 4- and 6-month psychological and physical responses is mediated by 0- to 2-month changes in depressive symptoms.
- Conditions
- Primary Malignant Brain Tumors
- Being tested
- CAU+ (Enhanced Care as Usual), Beating the Blues, SmartCare
- Keywords
- Neuro-oncology, Caregivers, Intervention Research, Representational Approach, Cognitive Behavioral Therapy, Family, Internet
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAU+ (Enhanced Care as Usual)Behavioural
CAU+ is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period.
Beating the BluesBehavioural
Beating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple "homework" after each lesson.
SmartCareBehavioural
SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.
| Study group | Role | What they receive |
|---|---|---|
| CAU+ (Enhanced Care as Usual) | Active comparator | CAU+ (Enhanced Care as Usual) is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page for the 10 month duration of the study. Receives: Behavioral: CAU+ (Enhanced Care as Usual) |
| CAU+ and SmartCare | Experimental | CAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. Receives: Behavioral: CAU+ (Enhanced Care as Usual); Behavioral: SmartCare |
| CAU+ and Beating the Blues and SmartCare | Experimental | CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms. Receives: Behavioral: CAU+ (Enhanced Care as Usual); Behavioral: Beating the Blues; Behavioral: SmartCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression from baseline at 4 months on the shortened CES-D
Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).
Measured: Baseline and 4 months
Secondary outcomes (16)
Change in unmet needs from baseline at 4 months on the CNS
Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Measured: Baseline and 4 months
Change in mastery from baseline at 4 months on the Caregiver Mastery Scale
Mastery will be measured using the Caregiver Mastery Scale.
Measured: Baseline and 4 months
Change in optimism from baseline at 4 months on the Life Orientation Test
Optimism will be measured using the Life Orientation Test.
Measured: Baseline and 4 months
Change spirituality from baseline at 4 months on the FACIT.
Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Measured: Baseline and 4 months.
Change in oversight demand from baseline at 4 months on the caregiver vigilance scale.
Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Measured: Baseline and 4 months
Change in social support from baseline at 4 months on the ISEL.
Social support will be measured using the Interpersonal Support Evaluation List (ISEL). Subjects rate the availability of three types of social support (appraisal, belonging, and tangible).
Measured: Baseline and 4 months.
Change in occupational functioning from baseline at 4 months on the WLQ.
Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ).
Measured: Baseline and 4 months.
Changes in positive aspects of providing care from baseline at 4 months on the PAC.
Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
Measured: Baseline and 4 months
Change in unmet needs from baseline at 6 months on the CNS
Unmet Needs will be measured via the Caregiver Needs Screen (CNS) questionnaire.
Measured: Baseline and 6 months
Change in mastery from baseline at 6 months on the Caregiver Mastery Scale
Mastery will be measured using the Caregiver Mastery Scale.
Measured: Baseline and 6 months
Change in optimism from baseline at 6 months on the Life Orientation Test
Optimism will be measured using the Life Orientation Test.
Measured: Baseline and 6 months
Change spirituality from baseline at 6 months on the FACIT.
Spirituality will measured using the Functional Assessment of Chronic Illness Therapy - Sp (FACIT).
Measured: Baseline and 6 months.
Change in oversight demand from baseline at 6 months on the caregiver vigilance scale.
Caregiver oversight demand will be measured using the four item Caregiver Vigilance Scale.
Measured: Baseline and 6 months
Change in social support from baseline at 6 months on the ISEL.
Social support will be measured using the Interpersonal Support Evaluation List (ISEL). Subjects rate the availability of three types of social support (appraisal, belonging, and tangible).
Measured: Baseline and 6 months.
Change in occupational functioning from baseline at 6 months on the WLQ.
Caregiver occupational functioning will be measured by general questions related to employment status and the Work Limitations Questionnaire (WLQ).
Measured: Baseline and 6 months.
Changes in positive aspects of providing care from baseline at 6 months on the PAC.
Positive aspects of providing care will be measured using the Positive Aspects of Caregiving (PAC) scale.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start1 Mar 2014
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Malignant Brain TumorsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Paula Sherwood, University of Pittsburgh
- Investigators
- Paula R Sherwood, PhD, Principal investigator, University of Pittsburgh, School of NursingHeidi S Donovan, PhD, Principal investigator, University of Pittsburgh, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058745
- Sponsor's protocol ID
- PRO11060487
- Other IDs
- R01NR013170
- Acronym
- SmartCare
- Status last verified
- Aug 2017
- First submitted
- 19 Nov 2013
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non-identifiable data will be shared with interested parties in agreement with University policy.
Publications
Sherwood PR, Boele F, Weimer J, Marsland A, Drappatz J, Armstrong TS, Terhorst L, Donovan HS. Neuro-oncology Caregiver Intervention Associated With Changes in C-Reactive Protein. Cancer Nurs. 2025 Apr 22. doi: 10.1097/NCC.0000000000001507. Online ahead of print.
PubMed 40266659Boele FW, Weimer JM, Marsland AL, Armstrong TS, Given CW, Drappatz J, Donovan HS, Sherwood PR. The effects of SmartCare(c) on neuro-oncology family caregivers' distress: a randomized controlled trial. Support Care Cancer. 2022 Mar;30(3):2059-2068. doi: 10.1007/s00520-021-06555-5. Epub 2021 Oct 16.
PubMed 34655326Boele FW, Weimer J, Zamanipoor Najafabadi AH, Murray L, Given CW, Given BA, Donovan HS, Drappatz J, Lieberman FS, Sherwood PR. The Added Value of Family Caregivers' Level of Mastery in Predicting Survival of Glioblastoma Patients: A Validation Study. Cancer Nurs. 2022 Sep-Oct 01;45(5):363-368. doi: 10.1097/NCC.0000000000001027. Epub 2021 Sep 30.
PubMed 34608049
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartCare: Innovations in Caregiving Interventions
- ClinicalTrials.gov ID
- NCT02058745
- Acronym / sponsor ID
- SmartCare / PRO11060487
- Conditions
- Primary Malignant Brain Tumors
- Keywords
- Neuro-oncology, Caregivers, Intervention Research, Representational Approach, Cognitive Behavioral Therapy, Family, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 10 Feb 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.
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
Detailed description
We have designed a needs-based intervention to improve neuro-oncology caregivers' health. Our novel approach treats depressive symptoms prior to implementing a needs-based intervention in a sample of PMBT family caregivers who score above threshold on depressive symptoms. Study outcomes are psychological responses (unmet needs, depressive symptoms, anxiety, and burden) and physical responses (levels of stimulated and circulating IL-6 and IL-1β, C-reactive protein, peripheral blood mono-nuclear cells, physical symptoms, and new diagnoses or exacerbations of co-morbid conditions). The proposed study addresses research priorities set by both NCI and NINR to improve the quality of life of patients and their families and NINR's emphasis on integrating bio-behavioral science and adopting, adapting and generating new technologies.
Primary aims:
- Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues) delivered prior to a needs-based caregiver intervention (SmartCare©) versus b) SmartCare© alone versus c) enhanced care as usual (CAU+) in improving caregivers' psychological and physical responses. H1: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to caregivers who receive CAU+. H2: At 4- and 6-months, caregivers who receive SmartCare© alone will display improved psychological and physical responses compared to caregivers who receive CAU+. H3: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to those who receive SmartCare© alone.
- Compare the efficacy of Beating the Blues versus CAU+ in improving subjects' short-term psychological and physical responses.
H1: At 2-months following baseline, caregivers who receive Beating the Blues will display improved psychological and physical responses compared to CAU+.
Exploratory aims:
- Determine whether any changes in psychological and physical health resulting from receiving Beating the Blues prior to SmartCare© or SmartCare© alone are maintained at 10-months after baseline.
- Evaluate whether the effect of Beating the Blues + SmartCare© (vs. SmartCare© alone) on 4- and 6-month psychological and physical responses is mediated by 0- to 2-month changes in depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAU+ (Enhanced Care as Usual) | Active comparator | Behavioral: CAU+ (Enhanced Care as Usual)CAU+ (Enhanced Care as Usual) is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page for the 10 month duration of the study. |
| CAU+ and SmartCare | Experimental | Behavioral: CAU+ (Enhanced Care as Usual), Behavioral: SmartCareCAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. |
| CAU+ and Beating the Blues and SmartCare | Experimental | Behavioral: CAU+ (Enhanced Care as Usual), Behavioral: Beating the Blues, Behavioral: SmartCareCAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 21 years of age.
- Newly (within 1 month) diagnosed with a PMBT (tumor verified via pathology report to be a glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, medulloblastoma, or anaplastic ependymoma).
- Primary nonprofessional, non-paid caregiver, as identified by the care recipient.
- Over 21 years of age with telephone access.
- Reads-speaks English
Key exclusion criteria (3 listed)
- Currently considers self to be a primary caregiver for anyone else other than children
- Currently receiving any type of formal counselling for depressive symptoms
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 |
|---|---|---|
| CAU+ (Enhanced Care as Usual)CAU+ is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page. These resources are routinely available on the Internet. We provide these as a "one-stop shopping" resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period. | Behavioural | CAU+ (Enhanced Care as Usual), CAU+ and Beating the Blues and SmartCare, CAU+ and SmartCare |
| Beating the BluesBeating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple "homework" after each lesson. | Behavioural | CAU+ and Beating the Blues and SmartCare |
| SmartCareSmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving. | Behavioural | CAU+ and Beating the Blues and SmartCare, CAU+ and SmartCare |
Primary outcome
Change in depression from baseline at 4 months on the shortened CES-D
Time frame: Baseline and 4 months
Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).
16 secondary outcomes
Change in unmet needs from baseline at 4 months on the CNS
Time frame: Baseline and 4 months
Change in mastery from baseline at 4 months on the Caregiver Mastery Scale
Time frame: Baseline and 4 months
Change in optimism from baseline at 4 months on the Life Orientation Test
Time frame: Baseline and 4 months
Change spirituality from baseline at 4 months on the FACIT.
Time frame: Baseline and 4 months.
Change in oversight demand from baseline at 4 months on the caregiver vigilance scale.
Time frame: Baseline and 4 months
Change in social support from baseline at 4 months on the ISEL.
Time frame: Baseline and 4 months.
Change in occupational functioning from baseline at 4 months on the WLQ.
Time frame: Baseline and 4 months.
Changes in positive aspects of providing care from baseline at 4 months on the PAC.
Time frame: Baseline and 4 months
Change in unmet needs from baseline at 6 months on the CNS
Time frame: Baseline and 6 months
Change in mastery from baseline at 6 months on the Caregiver Mastery Scale
Time frame: Baseline and 6 months
Change in optimism from baseline at 6 months on the Life Orientation Test
Time frame: Baseline and 6 months
Change spirituality from baseline at 6 months on the FACIT.
Time frame: Baseline and 6 months.
Change in oversight demand from baseline at 6 months on the caregiver vigilance scale.
Time frame: Baseline and 6 months
Change in social support from baseline at 6 months on the ISEL.
Time frame: Baseline and 6 months.
Change in occupational functioning from baseline at 6 months on the WLQ.
Time frame: Baseline and 6 months.
Changes in positive aspects of providing care from baseline at 6 months on the PAC.
Time frame: Baseline and 6 months
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 29 Aug 2017.
- Derived from this study: PubMed 40266659Sherwood PR, Boele F, Weimer J, Marsland A, Drappatz J, Armstrong TS, Terhorst L, Donovan HS. Neuro-oncology Caregiver Intervention Associated With Changes in C-Reactive Protein. Cancer Nurs. 2025 Apr 22. doi: 10.1097/NCC.0000000000001507. Online ahead of print.
- Derived from this study: PubMed 34655326Boele FW, Weimer JM, Marsland AL, Armstrong TS, Given CW, Drappatz J, Donovan HS, Sherwood PR. The effects of SmartCare(c) on neuro-oncology family caregivers' distress: a randomized controlled trial. Support Care Cancer. 2022 Mar;30(3):2059-2068. doi: 10.1007/s00520-021-06555-5. Epub 2021 Oct 16.
- Derived from this study: PubMed 34608049Boele FW, Weimer J, Zamanipoor Najafabadi AH, Murray L, Given CW, Given BA, Donovan HS, Drappatz J, Lieberman FS, Sherwood PR. The Added Value of Family Caregivers' Level of Mastery in Predicting Survival of Glioblastoma Patients: A Validation Study. Cancer Nurs. 2022 Sep-Oct 01;45(5):363-368. doi: 10.1097/NCC.0000000000001027. Epub 2021 Sep 30.
- Individual participant dataSharing planned: Yes. Non-identifiable data will be shared with interested parties in agreement with University policy.
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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.
Paula R Sherwood, PhD principal investigator
University of Pittsburgh, School of Nursing
Heidi S Donovan, PhD principal investigator
University of Pittsburgh, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAU+ (Enhanced Care as Usual), Beating the Blues and SmartCare in people with Primary Malignant Brain Tumors, run by University of Pittsburgh 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 9 inclusion and 3 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 29 Aug 2017. 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 depression from baseline at 4 months on the shortened CES-D (time frame: Baseline and 4 months). 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 NCT02058745, which also lists 3 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 29 Aug 2017.