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Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Insomnia and Depression (TIDE Trial)

N/A
Waitlist Available
Led By Kenneth L. Lichstein, Ph.D.
Research Sponsored by University of Alabama, Tuscaloosa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently receiving psychological treatment
50 years of age or older
Must not have
Intrusive and unstable concurrent psychiatric/medical disorders
Age is below 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month follow-up (23weeks post-treatment)
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether a combination of therapies can help reduce symptoms of insomnia and depression in adults.

Who is the study for?
The TIDE trial is for rural, African-American adults over 50 with both insomnia and depression. They must not be in current psychological treatment, have a stable mental status (MMSE score ≥24 or ≥17 if education ended at eighth grade), and can't be at serious risk of suicide. Participants need a referral from their primary care doctor within the Black Belt region.
What is being tested?
This study tests integrated Cognitive Behavioral Therapy (CBT) delivered via videoconferencing to treat insomnia and depression together, compared to usual care alone. It aims to see if this approach is feasible in rural settings and whether it improves sleep quality, mood, and life satisfaction more effectively than standard treatments.
What are the potential side effects?
Since CBT is a non-medical therapy involving talking and behavior change strategies without drugs, side effects are minimal but may include temporary increases in distress as difficult topics are discussed or changes in sleep patterns as new habits form.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently undergoing psychological therapy.
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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe mental health or unstable medical conditions.
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I am under 50 years old.
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I am currently in therapy for mental health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up (23weeks post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month follow-up (23weeks post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hamilton Depression Scale
Insomnia Severity Index
Secondary study objectives
GDS
SOL
WASO

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: CBTExperimental Treatment1 Intervention
Cognitive behavior therapy for both insomnia and depression featuring stimulus control and cognitive therapy.
Group II: Treatment as UsualActive Control1 Intervention
No additional treatment besides regular care.

Find a Location

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor
46 Previous Clinical Trials
17,532 Total Patients Enrolled
1 Trials studying Depression
302 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,892 Previous Clinical Trials
2,722,681 Total Patients Enrolled
696 Trials studying Depression
260,750 Patients Enrolled for Depression
Kenneth L. Lichstein, Ph.D.Principal InvestigatorUniversity of Alabama, Tuscaloosa

Media Library

Integrated Cognitive Behavioral Therapy (CBT) (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01648049 — N/A
Depression Research Study Groups: CBT, Treatment as Usual
Depression Clinical Trial 2023: Integrated Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT01648049 — N/A
Integrated Cognitive Behavioral Therapy (CBT) (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01648049 — N/A
~3 spots leftby Oct 2025
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