Depression study: Active Condition vs Active Comparator
Official title Assessing Improvements in Mood and Sleep Trial
ClinicalTrials.gov ID: NCT06639477
What this study is testing
- What it's testing
- This study is testing which of two approaches works best. It looks at how well each helps with bad moods, sleep, and suicide risk.
- Who it's for
- You may be able to join if you are 55 or older. You must have current depression and a sign of suicide risk.
- What's involved
- You would get one of two treatments picked by chance. You would wear a wrist device to track your activity for 8 weeks.
- Time commitment
- The study lasts 8 weeks starting from your first visit.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Age 55 Years and older
- Patient Health Questionnaire -9 score of 10 or higher
- Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
- PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
- Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
You likely can't join if
- Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an...
- Bipolar disorder
- Psychotic disorder
- Borderline personality disorder.
- Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
- Illness with life expectancy of less than 1 year or plans to leave the study area
See the full eligibility criteria
- Age 55 Years and older
- Patient Health Questionnaire -9 score of 10 or higher
- Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
- PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
- Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
- Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
- Bipolar disorder
- Psychotic disorder
- Borderline personality disorder.
- Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
- Illness with life expectancy of less than 1 year or plans to leave the study area
- Incapacity to consent/dementia diagnosis
- Active substance use disorder of at least moderate severity
- Active night-shift work
- Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Augusta, Georgia, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Augusta, Georgia, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.