Mental Health Wellness 1NCT03552783
Mental Health Intervention for Black Fathers
A study testing FFL + Cognitive Behavioral Therapy and Fathers for a Lifetime (FFL) only in people with Mental Health Wellness 1, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of implementing a mental health intervention, using individual and group Cognitive Behavior Therapy (CBT), embedded into Fathers for a Lifetime; an existing parenting program for fathers. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- FFL + Cognitive Behavioral Therapy and Fathers for a Lifetime (FFL) only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 20 Jan 2020
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American men
- Father
- 19 or older at the time of the enrollment
- Fluent in English (speaking and reading)
- Reside within the specific zip codes: 68104, 68110, 68111, 68112, and 68131
Who cannot join
- Females
- Not speaking English
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew Health Center, Inc.
Omaha, Nebraska, 68111
About this study
Official title: Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha
The purpose of this study is to examine the feasibility of implementing a mental health intervention, using individual and group Cognitive Behavior Therapy (CBT), embedded into Fathers for a Lifetime; an existing parenting program for fathers. The study will also assess the mental health status and daily functioning of fathers participating in the intervention and comparison arms. The mental health treatments available for parents focused on prevention and treatment of mothers or families but rarely was there a focus on fathers. Our study will use an existing parenting program for fathers to provide a mental health treatment for African American fathers with the intent of creating an effective treatment to screen, diagnosis, increase access to mental health services, and provide mental health treatment. By improving fathers' mental health, we can expect to see improvement in daily functioning, parent-parent interactions, parent-child interactions, increase confidence in parenting skills, and a decrease in parental stress.
Read the detailed description
The intervention will utilize the Cognitive Behavioral Therapy (CBT), an evidence-based psychotherapeutic approach to addressing mental health issues ranging from anxiety, depression, and other mental illnesses. CBT is based on a cognitive model, the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. The purpose of CBT is to help people focus on how to solve their current problems. The therapist helps the patient learn how to identify distorted or unhelpful thinking patterns, recognize and change inaccurate beliefs, relate to others in more positive ways, and change behaviors accordingly. Participants in the intervention arm will receive 12 weekly, one-hour, group CBT sessions, and three, one-hour, one-on-one therapy sessions throughout the 12-week Father For a LIfetime (FFL) program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum. For instance, the group CBT intervention will examine methods to build resiliency, develop skills to remain calm in stressful situations, learn coping skills when separated from their child/children, and learn how to cope with strained relationships. The FFL curriculum is adapted from the Wise Guys: Male Responsibility Curriculum, an evidence-informed curriculum designed to engage males in the prevention of pregnancies. The curriculum topics are broken into three categories: 1) personal responsibility, 2) responsibility to your child and 3) responsibility to your family and community. Figure 1 below displays the topic description covered each week within each category. The intention of our proposed therapeutic mental health intervention is to improve mental health status utilizing CBT in a group setting and initiating treatment of specific mental illnesses in the one-on-one therapy sessions to meet the unique needs of the father that may not be addressed in a group setting. Participants will receive the intervention immediately after the FFL programming concludes.
The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP) who will be trained to deliver the curriculum by the co-investigator and Senior Director of Behavioral Health Services at Charles Drew Health Center. In addition, the men will receive three one-on-one therapy sessions with a Charles Drew LIMHP that will be completed by the end of the FFL program. Participants in the comparison arm will receive the standard, 12-week program curriculum. Our proposed study falls within the T3 translational spectrum, which includes testing an intervention within a community setting by observing and gathering information on implementation to determine feasibility or effectiveness.
- Conditions
- Mental Health Wellness 1
- Being tested
- FFL + Cognitive Behavioral Therapy, Fathers for a Lifetime (FFL) only
- Keywords
- fathers, parenting, African American
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFL + Cognitive Behavioral TherapyBehavioural
Participants in the intervention arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime in addition to 12 weekly, one-hour, group CBT sessions, and three (3), one-hour, one-on-one therapy sessions throughout the 12-week FFL program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum.
Fathers for a Lifetime (FFL) onlyBehavioural
The participants in the comparison arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime. The curriculum is broken into three categories:
- Personal responsibility
- Personal responsibility to your child
- Responsibility to your family and community
| Study group | Role | What they receive |
|---|---|---|
| Fathers for a Lifetime (FFL) only | Active comparator | The participants in the comparison arm will receive the standard, 12-week program curriculum of Father For a Lifetime. Receives: Behavioral: Fathers for a Lifetime (FFL) only |
| FFL + Cognitive Behavioral Therapy | Experimental | The participants in the intervention will receive will the standard, 12-week program curriculum of Father For a Lifetime and the Cognitive Behavioral Therapy. The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP). In addition, the men will receive three one-on-one therapy sessions with a Charles Drew LIMHP that will be completed by the end of the FFL program. Receives: Behavioral: FFL + Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Follow-up rate: participants who completed the 12 weeks program
Measured: 12 weeks post-randomization
Secondary outcomes (6)
Mental health status
Defined according to the National Institute of Mental Health definition and DSM-V criteria
Measured: Baseline; 12 weeks post-randomization
Mental health diagnoses
National Institute of Mental Health definition and Diagnostic Statistical Manual (DSM)-V criteria
Measured: Baseline; 12 weeks post-randomization
Daily functioning
Four out of five domains of the Daily Living Activities (DLA-20) Functional Assessment: coping skills, communication, family relationships, and social networking.
Measured: Baseline; 12 weeks post-randomization
Number of FFL participants screened
Number of participants who completed the Intake Form and the DLA-20
Measured: Baseline
Refusal rates for participation
Number of participants who decline to participate in the study
Measured: Baseline; 12 weeks post-randomization
Adherence to study procedures
Participants who successfully followed the procedure
Measured: Baseline; 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start8 Mar 2019
- Primary completion30 Nov 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be a quasi-experimental study. The participants will be randomized into one of two study arms: Father For a Lifetime (FFL) + Cognitive Behavioral Therapy (CBT) (intervention arm) or FFL only (comparison arm).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keyonna M King, DrPH, Principal investigator, University of NebraskaPaul Estabrooks, PhD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552783
- Sponsor's protocol ID
- 0092-18-EP
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2018
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the entities involved in the study will have access to the participants' data. The data will be collected and temporarily stored at Charles Drew Health Center (the recruitment site). The participants' data will be stored and analyzed at the Center to Reduce Health Disparities/University of Nebraska Medical Center.
Publications
Sinkewicz M, Lee R. Prevalence, Comorbidity, and Course of Depression Among Black Fathers in the United States. Research on Social Work Practice 21(3): 289-297, 2011.
Klonoff EA, Landrine H, & Ullman JB. Racial discrimination and psychiatric symptoms among Blacks. Cultural Diversity and Ethnic Minority Psychology 5: 329-339, 1999.
Landrine H, Elisabeth A, Klonoff EA. The Schedule of Racist Events: A Measure of Racial Discrimination and a Study of Its Negative Physical and Mental Health Consequences. Journal of Black Psychology 22: 144-168, 1996.
Clifford LB, Mavaddat R, Hsu SY. The Experience and Consequences of Perceived Racial Discrimination: A Study of African Americans. Journal of Black Psychology 26: 165-180, 2000.
Sellers SL, Bonham V, Neighbors HW, Amell JW. Effects of racial discrimination and health behaviors on mental and physical health of middle-class African American men. Health Educ Behav. 2009 Feb;36(1):31-44. doi: 10.1177/1090198106293526. Epub 2006 Nov 27.
PubMed 17130248Rosin RD. Perspectives--IJS Issue No. 4, 2009. Int J Surg. 2009 Aug;7(4):277-8. doi: 10.1016/j.ijsu.2009.07.007. Epub 2009 Jul 23. No abstract available.
PubMed 19631298DeNavas-Walt C, Proctor PD, Smith J. Income, poverty, and health insurance coverage in the United States: 2006. Washington, DC: U.S. Census Bureau. 2007.
Huang CC, Warner LA. Relationship characteristics and depression among fathers with newborns. Soc Serv 79: 95-118, 2005.
DeKlyen M, Brooks-Gunn J, McLanahan S, Knab J. The mental health of married, cohabiting, and non-coresident parents with infants. Am J Public Health. 2006 Oct;96(10):1836-41. doi: 10.2105/AJPH.2004.049296. Epub 2006 Mar 29.
PubMed 16571717Amrock SM, Weitzman M. Parental psychological distress and children's mental health: results of a national survey. Acad Pediatr. 2014 Jul-Aug;14(4):375-81. doi: 10.1016/j.acap.2014.02.005. Epub 2014 May 29.
PubMed 24882378Paulson JF, Dauber S, Leiferman JA. Individual and combined effects of postpartum depression in mothers and fathers on parenting behavior. Pediatrics. 2006 Aug;118(2):659-68. doi: 10.1542/peds.2005-2948.
PubMed 16882821Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.
PubMed 15245835Das Eiden R, Leonard KE. Paternal alcoholism, parental psychopathology, and aggravation with infants. J Subst Abuse. 2000;11(1):17-29. doi: 10.1016/s0899-3289(99)00016-4.
PubMed 10756511McMahon TJ, Winkel JD, Rounsaville BJ. Drug abuse and responsible fathering: a comparative study of men enrolled in methadone maintenance treatment. Addiction. 2008 Feb;103(2):269-83. doi: 10.1111/j.1360-0443.2007.02075.x.
PubMed 18199306Beardslee WR, Gladstone TR, Wright EJ, Cooper AB. A family-based approach to the prevention of depressive symptoms in children at risk: evidence of parental and child change. Pediatrics. 2003 Aug;112(2):e119-31. doi: 10.1542/peds.112.2.e119.
PubMed 12897317
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha
- ClinicalTrials.gov ID
- NCT03552783
- Acronym / sponsor ID
- 0092-18-EP
- Conditions
- Mental Health Wellness 1
- Keywords
- fathers, parenting, African American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- 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.
The purpose of this study is to examine the feasibility of implementing a mental health intervention, using individual and group Cognitive Behavior Therapy (CBT), embedded into Fathers for a Lifetime; an existing parenting program for fathers. The study will also assess the mental health status and daily functioning of fathers participating in the intervention and comparison arms. The mental health treatments available for parents focused on prevention and treatment of mothers or families but rarely was there a focus on fathers. Our study will use an existing parenting program for fathers to provide a mental health treatment for African American fathers with the intent of creating an effective treatment to screen, diagnosis, increase access to mental health services, and provide mental health treatment. By improving fathers' mental health, we can expect to see improvement in daily functioning, parent-parent interactions, parent-child interactions, increase confidence in parenting skills, and a decrease in parental stress.
Detailed description
The intervention will utilize the Cognitive Behavioral Therapy (CBT), an evidence-based psychotherapeutic approach to addressing mental health issues ranging from anxiety, depression, and other mental illnesses. CBT is based on a cognitive model, the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. The purpose of CBT is to help people focus on how to solve their current problems. The therapist helps the patient learn how to identify distorted or unhelpful thinking patterns, recognize and change inaccurate beliefs, relate to others in more positive ways, and change behaviors accordingly. Participants in the intervention arm will receive 12 weekly, one-hour, group CBT sessions, and three, one-hour, one-on-one therapy sessions throughout the 12-week Father For a LIfetime (FFL) program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum. For instance, the group CBT intervention will examine methods to build resiliency, develop skills to remain calm in stressful situations, learn coping skills when separated from their child/children, and learn how to cope with strained relationships. The FFL curriculum is adapted from the Wise Guys: Male Responsibility Curriculum, an evidence-informed curriculum designed to engage males in the prevention of pregnancies. The curriculum topics are broken into three categories: 1) personal responsibility, 2) responsibility to your child and 3) responsibility to your family and community. Figure 1 below displays the topic description covered each week within each category. The intention of our proposed therapeutic mental health intervention is to improve mental health status utilizing CBT in a group setting and initiating treatment of specific mental illnesses in the one-on-one therapy sessions to meet the unique needs of the father that may not be addressed in a group setting. Participants will receive the intervention immediately after the FFL programming concludes.
The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP) who will be trained to deliver the curriculum by the co-investigator and Senior Director of Behavioral Health Services at Charles Drew Health Center. In addition, the men will receive three one-on-one therapy sessions with a Charles Drew LIMHP that will be completed by the end of the FFL program. Participants in the comparison arm will receive the standard, 12-week program curriculum. Our proposed study falls within the T3 translational spectrum, which includes testing an intervention within a community setting by observing and gathering information on implementation to determine feasibility or effectiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention will be a quasi-experimental study. The participants will be randomized into one of two study arms: Father For a Lifetime (FFL) + Cognitive Behavioral Therapy (CBT) (intervention arm) or FFL only (comparison arm).
| Arm | Type | Receives |
|---|---|---|
| Fathers for a Lifetime (FFL) only | Active comparator | Behavioral: Fathers for a Lifetime (FFL) onlyThe participants in the comparison arm will receive the standard, 12-week program curriculum of Father For a Lifetime. |
| FFL + Cognitive Behavioral Therapy | Experimental | Behavioral: FFL + Cognitive Behavioral TherapyThe participants in the intervention will receive will the standard, 12-week program curriculum of Father For a Lifetime and the Cognitive Behavioral Therapy. The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP). In addition, the men will receive three one-on-one therapy sessions with a Charles Drew LIMHP that will be completed by the end of the FFL program. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American men
- Father
- 19 or older at the time of the enrollment
- Fluent in English (speaking and reading)
- Reside within the specific zip codes: 68104, 68110, 68111, 68112, and 68131
Key exclusion criteria (2 listed)
- Females
- Not speaking English
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 |
|---|---|---|
| FFL + Cognitive Behavioral TherapyParticipants in the intervention arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime in addition to 12 weekly, one-hour, group CBT sessions, and three (3), one-hour, one-on-one therapy sessions throughout the 12-week FFL program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum. | Behavioural | FFL + Cognitive Behavioral Therapy |
| Fathers for a Lifetime (FFL) onlyThe participants in the comparison arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime. The curriculum is broken into three categories: 1. Personal responsibility 2. Personal responsibility to your child 3. Responsibility to your family and community | Behavioural | Fathers for a Lifetime (FFL) only |
Primary outcome
Attrition
Time frame: 12 weeks post-randomization
Follow-up rate: participants who completed the 12 weeks program
6 secondary outcomes
Mental health status
Time frame: Baseline; 12 weeks post-randomization
Mental health diagnoses
Time frame: Baseline; 12 weeks post-randomization
Daily functioning
Time frame: Baseline; 12 weeks post-randomization
Number of FFL participants screened
Time frame: Baseline
Refusal rates for participation
Time frame: Baseline; 12 weeks post-randomization
Adherence to study procedures
Time frame: Baseline; 12 weeks post-randomization
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 Sep 2023.
- BackgroundSinkewicz M, Lee R. Prevalence, Comorbidity, and Course of Depression Among Black Fathers in the United States. Research on Social Work Practice 21(3): 289-297, 2011.
- BackgroundKlonoff EA, Landrine H, & Ullman JB. Racial discrimination and psychiatric symptoms among Blacks. Cultural Diversity and Ethnic Minority Psychology 5: 329-339, 1999.
- BackgroundLandrine H, Elisabeth A, Klonoff EA. The Schedule of Racist Events: A Measure of Racial Discrimination and a Study of Its Negative Physical and Mental Health Consequences. Journal of Black Psychology 22: 144-168, 1996.
- BackgroundClifford LB, Mavaddat R, Hsu SY. The Experience and Consequences of Perceived Racial Discrimination: A Study of African Americans. Journal of Black Psychology 26: 165-180, 2000.
- Background: PubMed 17130248Sellers SL, Bonham V, Neighbors HW, Amell JW. Effects of racial discrimination and health behaviors on mental and physical health of middle-class African American men. Health Educ Behav. 2009 Feb;36(1):31-44. doi: 10.1177/1090198106293526. Epub 2006 Nov 27.
- Background: PubMed 19631298Rosin RD. Perspectives--IJS Issue No. 4, 2009. Int J Surg. 2009 Aug;7(4):277-8. doi: 10.1016/j.ijsu.2009.07.007. Epub 2009 Jul 23. No abstract available.
- BackgroundDeNavas-Walt C, Proctor PD, Smith J. Income, poverty, and health insurance coverage in the United States: 2006. Washington, DC: U.S. Census Bureau. 2007.
- BackgroundHuang CC, Warner LA. Relationship characteristics and depression among fathers with newborns. Soc Serv 79: 95-118, 2005.
- Background: PubMed 16571717DeKlyen M, Brooks-Gunn J, McLanahan S, Knab J. The mental health of married, cohabiting, and non-coresident parents with infants. Am J Public Health. 2006 Oct;96(10):1836-41. doi: 10.2105/AJPH.2004.049296. Epub 2006 Mar 29.
- Background: PubMed 24882378Amrock SM, Weitzman M. Parental psychological distress and children's mental health: results of a national survey. Acad Pediatr. 2014 Jul-Aug;14(4):375-81. doi: 10.1016/j.acap.2014.02.005. Epub 2014 May 29.
- Background: PubMed 16882821Paulson JF, Dauber S, Leiferman JA. Individual and combined effects of postpartum depression in mothers and fathers on parenting behavior. Pediatrics. 2006 Aug;118(2):659-68. doi: 10.1542/peds.2005-2948.
- Background: PubMed 15245835Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.
- National Institute of Mental Health. RAISE Glossary.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only the entities involved in the study will have access to the participants' data. The data will be collected and temporarily stored at Charles Drew Health Center (the recruitment site). The participants' data will be stored and analyzed at the Center to Reduce Health Disparities/University of Nebraska Medical Center.
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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.
Keyonna M King, DrPH principal investigator
University of Nebraska
Paul Estabrooks, PhD study chair
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFL + Cognitive Behavioral Therapy and Fathers for a Lifetime (FFL) only in people with Mental Health Wellness 1, run by University of Nebraska 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 2 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 Sep 2023. 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?
Attrition (time frame: 12 weeks post-randomization). 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 NCT03552783, which also lists 51 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 Sep 2023.