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Assessing Improvements in Mood and Sleep Trial

Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit."
  • "There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health."
  • "After the first main visit is complete, participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks (8 sessions total)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two approaches to improve sleep, mood, and suicidal thoughts or actions. It is for adults age 55 or older who have depression symptoms, sleep problems, and current suicidal thoughts or a past suicide attempt. Participants will complete interviews and surveys and wear a device that tracks movement for 8 weeks.

This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 55 or older.
  • A score of 10 or higher on the PHQ-9 depression survey.
  • A score of 3 or higher on a survey of suicidal thoughts in the past month, or any past suicide attempt.
  • A T-score of 55 or higher on a PROMIS survey of sleep problems or their effects on daily life.
  • Taking depression medicine for at least 4 weeks at a dose that meets the study’s minimum, based on FDA approval documents.

Who can't join

  • Planning suicide with intent to act, suicide risk judged too high for care outside a hospital, or currently receiving inpatient care.
  • Bipolar disorder (major mood swings), a psychotic disorder (trouble knowing what is real), or borderline personality disorder (ongoing problems managing emotions and relationships).
  • Current cognitive or behavioral therapy, such as CBT-I for sleep; current or planned esketamine (ketamine) treatment; or an active course of ECT or TMS brain stimulation treatment.
  • An illness with an expected lifespan of less than 1 year, or plans to leave the study area.
  • Unable to give informed consent, or diagnosed with dementia, which affects memory and thinking.
  • A current, at least moderate substance use disorder, meaning alcohol or drug use that causes serious problems.
  • Currently working night shifts.
  • Any physical, mental, or nervous system condition that would make the study or either treatment unsafe or not possible.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * 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.

Study sites (3)

CA

GA

PA