Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Rare Diseases

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

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

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.

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.

cognitive behavioral therapy for insomnia (CBTI)

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.

Waitlist control condition

Bruce Rybarczyk, PhD

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.

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.

CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients

CBT-I is a cognitive behavioral therapy for insomnia. 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.

Massey Cancer Center

Virginia Commonwealth University

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Cognitive Behavioral Therapy for Insomnia (CBTI)

Six 15-30 minute in-person or phone sessions that incorporate cognitive, behavioral and psycho-educational techniques focused on modifying the perpetuating factors that maintain insomnia.

Six 15-30 minute in-person or phone sessions that begin with a review of the sleep diary, a general discussion of treatment progress and tabulation of sleep parameters.

Behavioral Placebo Treatment

Ellyn E Matthews, PhD,RN,AOCN

The primary goal of the proposed study is to examine a cognitive behavioral intervention for insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to evaluate the effect of CBTI on sleep and clinically relevant outcomes.

The overall goals of this study are to: 1) test standard 4-component CBTI in patients with breast cancer post-treatment, 2) gather data on the feasibility of the methods, and 3) determine effects of the intervention on quality of life (QOL) and daily functioning. Sixty women after completion of primary breast cancer treatment, 21-65 years of age, who meet the criteria for chronic insomnia will be recruited from two Western U.S. Cancer Centers. Participants will be randomized to one of two treatment conditions (CBTI or behavioral placebo treatment). Both groups will receive six in-office and phone sessions. The control group will receive the same amount of individualized attention. Sleep efficiency and component measures (e.g., sleep onset latency, minutes awake after sleep onset) and quality of life and component measures of daily functioning will be assess pre and post-intervention, and at 3- and 6-month follow up visits. It is hypothesized that women receiving CBTI treatment will demonstrate greater increase in sleep efficiency (time in bed compared with time asleep) and will self-report greater improvements in QOL and daily functioning compared to those receiving a behavioral placebo treatment at the conclusion of the intervention and at 3- to 6-month follow-ups. Established instruments include the Insomnia Severity Index, Morin Sleep Diary, Dysfunctional Beliefs and Attitudes about Sleep-16, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30, Attentional Function Index, Revised Piper Fatigue Scale, and Hospital Anxiety and Depression Scale. Subjective data will be corroborated with actigraphy. Results may inform development of clinical guidelines for insomnia management after cancer treatment. The proposed study associated with this K23 award relates to the Health People 2010 goal of improving quality of life of individuals of all ages, and the cancer focus area goal of reducing illness and disability caused by cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients	NCT02410564	Cancer Chronic Insomni...	cognitive behav... Waitlist contro...	18 Years -	Virginia Commonwealth University
CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients	NCT02410564	Cancer Chronic Insomni...	cognitive behav... Waitlist contro...	18 Years -	Virginia Commonwealth University
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment	NCT00672217	Breast Cancer	Cognitive Behav... Behavioral Plac...	21 Years - 65 Years	University of Colorado, Denver
Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment	NCT00672217	Breast Cancer	Cognitive Behav... Behavioral Plac...	21 Years - 65 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for cognitive behavioral therapy for insomnia (cbti)