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Cognitive Behavioral Therapy for Psychological Adaptation

N/A

Waitlist Available

Led By Deidre B. Pereira, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-surgery (t0, which is baseline), 6-8 weeks (t1, which is post-surgery and pre-intervention), 12-16 weeks (t2, which is post-intervention), and 18-24 weeks (t3, which is follow-up)

Awards & highlights

Study Summary

This trial will study the effects of a psychosocial intervention on sleep, pain, mood, cortisol, and cytokines in women with gynecologic cancers.

Eligible Conditions

Psychological Adaptation
Genital Warts
Insomnia
Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-surgery (t0, which is baseline), 6-8 weeks (t1, which is post-surgery and pre-intervention), 12-16 weeks (t2, which is post-intervention), and 18-24 weeks (t3, which is follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-surgery (t0, which is baseline), 6-8 weeks (t1, which is post-surgery and pre-intervention), 12-16 weeks (t2, which is post-intervention), and 18-24 weeks (t3, which is follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery (t0, which is baseline), 6-8 weeks (t1, which is post-surgery and pre-intervention), 12-16 weeks (t2, which is post-intervention), and 18-24 weeks (t3, which is follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diurnal Salivary Cortisol Rhythm

Pain Interference

Pain Quality and Intensity

+5 more

Secondary outcome measures

A-Delta Nerve Fiber (First Pain) Response

Anxious Mood

C Nerve Fiber (Second Pain) Response

+1 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention

This group will receive Cognitive Behavioral Therapy to optimize sleep, pain, and mood in women with gynecologic cancers. The therapy will be provided on a one-on-one basis, for 2 hours once a week for six weeks by a trained therapist with a master's degree in Clinical Psychology.

Group II: PsychoeducationPlacebo Group1 Intervention

This group will receive Psychoeducation which is aimed at providing information, resources, and non-specific support related to adapting well to cancer. The education will be provided on a one-on-one basis, for 2 hours once a week for six weeks by a trained therapist with a master's degree in Clinical Psychology.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,632 Total Patients Enrolled

University of MiamiOTHER

898 Previous Clinical Trials

409,587 Total Patients Enrolled

1 Trials studying Psychological Adaptation

60 Patients Enrolled for Psychological Adaptation

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,259 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor looking for participants aged twenty and above?

"This clinical trial is intended for subjects aged 18 to 90 years old. There are 99 trials specifically tailored towards those under the age of majority and 474 studies accommodating individuals over 65."

Answered by AI

Is this experiment recruiting participants at the present time?

"According to the research hosted on clinicaltrials.gov, this medical trial is currently at capacity and not accepting new patients. This particular study was initially posted July 1st 2009 and last updated December 1st 2021. However, 624 other studies are actively recruiting participants right now."

Answered by AI

What is the desired result of this clinical examination?

"This clinical trial has a primary aim of assessing Subjective Sleep Quality, and several secondary objectives. These include evaluating the A-Delta Nerve Fiber (First Pain) Response via Graded Thermal Stimulation or RAMP and HOLD testing for pain severity ratings, quantifying anxious mood with State-Trait Anxiety Inventory scores, and measuring C Nerve Fiber (Second Pain) Response using a Thermal Protocol for Temporal Summation or Wind-Up Quantitative Sensory Testing. The evaluation period will cover Pre-surgery (T0), 6 to 8 weeks post surgery pre-intervention(T1), 12 to 16 weeks post"

Answered by AI

Recent research and studies

Pain MedicineJournal

Associations Among Sleep Latency, Subjective Pain, and Thermal Pain Sensitivity in Gynecologic Cancer

Kirsch, Janae L, Michael E Robinson, Christina S McCrae, Elizabeth L Kacel, Shan S Wong, Seema Patidar, Timothy S Sannes, Stephanie Garey, Jacqueline C Castagno, and Deidre B Pereira. 2018. “Associations Among Sleep Latency, Subjective Pain, and Thermal Pain Sensitivity in Gynecologic Cancer”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pny236.

Health PsychologyJournal

Interleukin-6 and Body Mass Index, Tobacco Use, and Sleep in Gynecologic Cancers.

Kacel, Elizabeth L., Janae L. Kirsch, Timothy S. Sannes, Seema Patidar, Rachel Postupack, Sally Jensen, Shan Wong, et al.. 2019. “Interleukin-6 and Body Mass Index, Tobacco Use, and Sleep in Gynecologic Cancers.”. Health Psychology. American Psychological Association (APA). doi:10.1037/hea0000775.

clinicaltrials.govStudy

Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer

2009. "Cognitive Behavioral Effects on Sleep, Pain, and Cytokines in Gynecologic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02609880.