← Back to Search

Behavioral Intervention

Treatments for Depression (AIMS Trial)

N/A

Waitlist Available

Led By Stephen F Smagula, Ph.D

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher

Age 55 Years and older

Must not have

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

Incapacity to consent/dementia diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of treatment at 6-months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand which approach is better at improving symptoms like trouble sleeping, bad moods, and suicidal thoughts in individuals aged 55 and older who are currently experiencing depression symptoms and have a risk

Who is the study for?

This trial is for individuals aged 55 or older who are currently experiencing symptoms of depression and have a risk indicator for suicide, such as current suicidal thoughts or a past attempt. They must be able to complete interviews, self-reports, and wear an actigraphy device for sleep tracking over 8 weeks.

What is being tested?

The study compares two different approaches to see which one better improves sleep issues, mood, and suicidality in older adults with depression. Participants will receive either the usual treatment they would get from their healthcare provider or one of two active treatments being compared.

What are the potential side effects?

Since specific interventions aren't detailed here, side effects can vary widely but may include typical reactions to mental health treatments like changes in mood, energy levels, appetite or sleeping patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have significant sleep problems.

Select...

I am 55 years old or older.

Select...

I have been on depression medication at the recommended dose for at least 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving inpatient care or considered at high risk for suicide.

Select...

I have been diagnosed with dementia or cannot give consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of treatment at 6-months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of treatment at 6-months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 6-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression Symptom Response

Secondary study objectives

Change in Suicide Ideation Severity

Suicide Behavior Outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active ConditionExperimental Treatment2 Interventions

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Group II: Concealed Control InterventionActive Control2 Interventions

0 / 5Eligibility criteria met