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Behavioral Intervention
Cognitive Behavioral Therapy for Suicidal Thoughts in Older Adults (ANSWERS-OA Trial)
N/A
Waitlist Available
Led By Michael A Grandner, PhD
Research Sponsored by MICHAEL A GRANDNER
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current insomnia (Insomnia Severity Index score ≥ 8 during the baseline period)
Individuals 65 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
ANSWERS-OA Trial Summary
This trial will investigate whether digital cognitive behavioral therapy for insomnia (dCBT-I) is effective for reducing suicidal ideation in older adults.
Who is the study for?
This trial is for English-speaking individuals aged 65 or older with insomnia and recent suicidal thoughts. They must be willing to share information between the research team and their mental health provider, not work night shifts, have internet access, and not plan to change psychotropic medications during the trial.Check my eligibility
What is being tested?
The study tests digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in older adults to see if it reduces suicidal thinking. It's a preliminary investigation into whether treating sleep problems can help alleviate suicide risk factors without necessarily improving cognition.See study design
What are the potential side effects?
Since dCBT-I is a non-pharmacological treatment involving behavioral changes and cognitive exercises through digital means, typical medication side effects are not expected. However, participants may experience frustration or discomfort adjusting to new sleep habits.
ANSWERS-OA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I currently have trouble sleeping.
Select...
I am 65 years old or older.
ANSWERS-OA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AIM 2: Investigate whether dCBT-I is safe for older adults with suicidal ideation.
Aim 1a: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Aim 1b: Evaluate whether dCBT-I is a feasible intervention for older adults with insomnia and suicidal ideation.
Secondary outcome measures
AIM 3: Explore whether dCBT-I can reduce suicidal ideation in older adults.
ANSWERS-OA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: digital Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Following baseline evaluation, participants in this group will receive 8 weeks of digital Cognitive Behavioral Therapy for Insomnia delivered using Sleep Healthy Using the Internet (SHUTi). After the interim assessment, participants will then crossover to 8 weeks of active monitoring.
Group II: Waitlist ControlActive Control1 Intervention
Following baseline evaluation, participants in this group will undergo weekly monitoring of insomnia and suicidal ideation for 8 weeks. Participants will continue whatever treatments they are currently receiving, but will receive no specific instructions or behavioral interventions for insomnia. After the interim assessment, participants will then crossover to receive digital Cognitive Behavioral Therapy for Insomnia.
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Who is running the clinical trial?
MICHAEL A GRANDNERLead Sponsor
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,880,018 Total Patients Enrolled
Michael A Grandner, PhDPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have bipolar, psychotic disorders, or other serious mental illnesses.I might have a sleep disorder like sleep apnea or restless legs syndrome that hasn't been treated.I currently have trouble sleeping.I haven't taken any psychotropic drugs for 6 weeks and won't start any new ones during the trial.I am 65 years old or older.I haven't changed my mental health medication dose in the last 6 weeks and won't change it during the trial.I do not have any uncontrolled or unstable chronic conditions.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: digital Cognitive Behavioral Therapy for Insomnia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts ongoing for this clinical research?
"This research project, which was originally posted on September 1st 2021 and revised on May 20th 2022, is not currently accepting applicants. Nevertheless, 418 other studies are actively enrolling patients at this time."
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