CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

NCT ID: NCT02410564

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-31

Brief Summary

To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.

Detailed Description

The proposed study will be a randomized controlled trial design. Participants will be randomized to either a CBTI treatment or a wait list control condition. The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. All participants will have a face to face meeting with the doctoral student at enrollment. During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. Pretreatment, all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

Conditions

Cancer; Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CBTI treatment

cognitive behavioral therapy for insomnia (CBTI) treatment is a validated web based version of CBT-I, which will take place over seven weeks and will include a combination of face-to-face and telephone sessions, and email updates

Group Type: ACTIVE_COMPARATOR

cognitive behavioral therapy for insomnia (CBTI)

Intervention Type: BEHAVIORAL

SHUTi program is made up of six, weekly treatment Cores modeled after weekly facetoface(CBTI). Each Core begins by providing a rationale for learning the material, explains main content, homework page with suggestions for improving sleep, and a summarized review of main points. The main content each Core addresses myths about sleep, indepth information about topics, vignettes, and quizzes to evaluate users learning in an interactive. As well as being interactive, SHUTi allows for personalization.Modifications are made to sleep recommendations based in sleep diary data and individually set treatment goals. The cores include Overview, Sleep Behavior Core, Sleep Behavior Core 2, Sleep Education Core, Sleep Thoughts Core, and Problem Prevention Core. Each Core takes approximately 45 to 60 minutes to complete. Cores are presented one at a time; next Core becomes available to users a week after they complete one Core.

Waitlist control condition

No advice regarding sleep will be given to the control group and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.

Group Type: PLACEBO_COMPARATOR

Waitlist control condition

Intervention Type: BEHAVIORAL

Phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.

Interventions

cognitive behavioral therapy for insomnia (CBTI)

SHUTi program is made up of six, weekly treatment Cores modeled after weekly facetoface(CBTI). Each Core begins by providing a rationale for learning the material, explains main content, homework page with suggestions for improving sleep, and a summarized review of main points. The main content each Core addresses myths about sleep, indepth information about topics, vignettes, and quizzes to evaluate users learning in an interactive. As well as being interactive, SHUTi allows for personalization.Modifications are made to sleep recommendations based in sleep diary data and individually set treatment goals. The cores include Overview, Sleep Behavior Core, Sleep Behavior Core 2, Sleep Education Core, Sleep Thoughts Core, and Problem Prevention Core. Each Core takes approximately 45 to 60 minutes to complete. Cores are presented one at a time; next Core becomes available to users a week after they complete one Core.

Intervention Type: BEHAVIORAL

Waitlist control condition

Phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

SHUTi; control

Eligibility Criteria

Inclusion Criteria

• newly diagnosed with I-III non-metastatic cancer
• scheduled to begin chemotherapy or radiotherapy
• chemotherapy or radiotherapynaïve
• meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
• Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
• interested in behavioral sleep treatment
• have the permission of their oncologists to participate.

Exclusion Criteria

• untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder
• medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
• untreated sleep disorders such as sleep apnea

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massey Cancer Center

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Rybarczyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20002827

Identifier Type: -

Identifier Source: secondary_id

MCC-14-10761

Identifier Type: -

Identifier Source: org_study_id