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Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia

University of Pennsylvania, Philadelphia, PA
Chronic Insomnia+2 More ConditionsCognitive Behavioral Therapy for Insomnia - Behavioral
Eligibility
25 - 85
Female

Study Summary

This trial will study whether a higher dose of CBT-I is more effective in treating cancer-related fatigue than the standard dose.

Eligible Conditions
  • Chronic Insomnia
  • Cancer-Related Syndrome
  • Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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1
Antidepressant
1
Cognitive Behavioral Therapy-Insomnia (CBT-I)
1
Speeko for Elderspeak

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Baseline to End of Treatment (Up to 12 weeks)

Week 12
Adherence
Recruitment
Retention
End of Treatment
Treatment Acceptability

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

2
Antidepressant
1
Cognitive Behavioral Therapy-Insomnia (CBT-I)
1
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Side Effects for

Antidepressant + Desensitization
1%Hematoma R side abdomen
1%Severe vaginal bleeding and pain
1%Chest pain in a patient with CAD
1%Asthma
This histogram enumerates side effects from a completed 2015 Phase 2 & 3 trial (NCT00767624) in the Antidepressant + Desensitization ARM group. Side effects include: Hematoma R side abdomen with 1%, Severe vaginal bleeding and pain with 1%, Chest pain in a patient with CAD with 1%, Asthma with 1%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Eight Sessions of CBT-I
1 of 4
Ten Sessions of CBT-I
1 of 4
Four Sessions of CBT-I
1 of 4
Twelve Sessions of CBT-I
1 of 4

Experimental Treatment

70 Total Participants · 4 Treatment Groups

Primary Treatment: Cognitive Behavioral Therapy for Insomnia · No Placebo Group · N/A

Eight Sessions of CBT-I
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Ten Sessions of CBT-I
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Four Sessions of CBT-I
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Twelve Sessions of CBT-I
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1460

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of treatment (up to 12 weeks)

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
358 Previous Clinical Trials
107,184 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,323 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,899 Previous Clinical Trials
41,218,023 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,734 Total Patients Enrolled

Eligibility Criteria

Age 25 - 85 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have trouble sleeping and experience fatigue, as measured by certain tests. You do not have any major medical or mental health conditions that could affect the study.
References

Frequently Asked Questions

Is geriatric care being offered to those over 65 years of age in this trial?

"The guidelines for this clinical trial stipulate that the minimum age to participate is 25 and the maximum age is 85." - Anonymous Online Contributor

Unverified Answer

What criteria must an individual satisfy to be eligible for this trial?

"Through this clinical trial, 70 people aged between 25 and 85 with cancer are being enrolled. In order to participate in the study, candidates must meet the following criteria: A diagnosis of organ-confined BC; Consent for participation; Suffering from insomnia and CRF as indicated by ISI, PROMIS 7a and FACIT-F scores; Being free from any significant medical (e.g., OSA) or psychiatric conditions (e.g., PTSD); RT treatment completed prior to enrollment." - Anonymous Online Contributor

Unverified Answer

Are there still available slots for individuals looking to join this research experiment?

"Based on clinicaltrials.gov, this scientific experiment is no longer actively searching for participants. First posted on 2/1/2023 and last updated on 10/31/2022, the study has closed its doors to potential candidates; however, there are 2808 other trials currently recruiting patients across the world." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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