Therapist-directed Cognitive Behavioral Therapy (TCBT) for Primary Insomnia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Primary Insomnia+1 MoreTherapist-directed Cognitive Behavioral Therapy (TCBT) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care.

Eligible Conditions
  • Primary Insomnia
  • Obstructive Sleep Apnea

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Adherence data will be collected through study completion, an average of one year.

Adherence data will be collected through study completion, an average of one year.
Positive Airway Pressure (PAP) Therapy Adherence
Week 1
Quebec Sleep Questionnaire (QSQ) score change
Month 9
Change in subjective measurement of sleep efficiency
Change in subjective measurement of total sleep time
Week 28
Insomnia Severity Index (ISI) score change

Trial Safety

Trial Design

2 Treatment Groups

Standard Care
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

384 Total Participants · 2 Treatment Groups

Primary Treatment: Therapist-directed Cognitive Behavioral Therapy (TCBT) · No Placebo Group · N/A

InterventionExperimental Group · 2 Interventions: Online Cognitive Behavioral Therapy (OCBT), Therapist-directed Cognitive Behavioral Therapy (TCBT) · Intervention Types: Behavioral, Behavioral
Standard CareNoIntervention Group · 1 Intervention: Standard Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: adherence data will be collected through study completion, an average of one year.

Who is running the clinical trial?

Stanford UniversityOTHER
2,170 Previous Clinical Trials
35,767,899 Total Patients Enrolled
National Jewish HealthLead Sponsor
135 Previous Clinical Trials
317,930 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have persistent sleep onset or sleep maintenance difficulties despite having adequate opportunity for sleep and accompanied by significant daytime impairment or distress about poor sleep.
You have a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights per week during two weeks of sleep diary monitoring.