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

A 6-week online cognitive-behavioural treatment for insomnia. Each week focuses on a different topic consistent with the cognitive-behavioural theory of insomnia.

The online attention matched control arm will provide education about sleep without any focus on the active ingredients that constitute the intervention group.

psychoeducation about insomnia, relaxation training, sleep restriction, stimulus control, hypnotic tapering under direction of a physician, cognitive therapy, sleep hygiene

Cognitive Behavioural Therapy

Cheryl Harris

Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general population. The Pan-Canadian sleep guideline for adults with cancer recommends Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems, however, are the lack of available CBT-I at cancer centers and the lack of information about possible side-effects of CBT-I. To address this issue, our study will evaluate the effectiveness and potential short-term side-effects of an online version of CBT-I. It is expected that when compared to cancer survivors who receive an online sleep education program, those who receive online CBT-I will experience improved sleep, mood, and quality of life, as well as reduced anxiety and fatigue.

Insomnia is a common adverse effect of cancer and its treatment. More than 25% of cancer survivors meet diagnostic criteria, a rate at least two times higher than that of the general population. Despite the pervasiveness of the problem, insomnia is underdiagnosed and undertreated in cancer survivors, resulting in significant suffering and associated consequences such as fatigue, cognitive issues, mood disturbance, functional disability, decreased quality of life, and immunosuppression. Consistent with recent evidence that group cognitive behavioral therapy for insomnia (CBT-I) is effective in treating insomnia in cancer survivors, CBT-I is recommended as first line treatment in the new Pan-Canadian practice guideline for sleep disturbance in adults with cancer. A major barrier to practical application of this recommendation however, is the lack of appropriately trained professionals at cancer centres. Moreover, it is assumed that in contrast to pharmacotherapy, CBT-I is free of treatment-related side-effects; however, we have no knowledge of symptoms that may be experienced by cancer survivors and/or exacerbated during CBT-I treatment (e.g., increased fatigue, cognitive impairment) because such effects are not systematically monitored. With the goal of improved access to CBT-I, online versions have been developed. One initial evaluation has been conducted in cancer patients with promising results, although limitations of the study include a small sample size (n = 28), control condition that failed to match for modality and time, lack of follow-up data, and failure to investigate potential side effects during treatment. Further inquiry is clearly warranted and consistent with insights of Canadian cancer patients who have suggested the use of technology as a factor that would facilitate their participation in an insomnia treatment program.

Specific research questions to be addressed in our proposed two-group, randomized, controlled trial include: 1) Do cancer survivors with chronic insomnia who receive a 6-week, internet-based CBT-I treatment have greater improvement in insomnia severity and other secondary sleep and quality of life outcomes, than participants in an online sleep education control group? 2) Are there short-term side-effects associated with CBT-I for cancer survivors (i.e., do participants get worse before they get better)?

Adult outpatients diagnosed with any type of cancer (stages I-III), completed active treatment for at least 1 month (with the exception of hormone therapy) and without cancer recurrence will be will be recruited from The Ottawa Hospital Cancer Centre and Cancercare Manitoba (n = 150). All will meet established diagnostic and research criteria for chronic insomnia. Prior to acceptance in the study, the procedures will be fully explained, inclusion/exclusion criteria assessed, and formal consent obtained. Once accepted into the study, participants will be randomized (stratified by hormone therapy-yes or no) to one of the two study arms. Online assessment measures (insomnia severity, pre-sleep arousal, beliefs about sleep, fatigue, mood, anxiety, quality of life) will be completed at the baseline period, at week 6 (post treatment), and at 3 month follow-up; however, online diary assessments of sleep parameters and potential side-effects (fatigue, affect, cognition, pain, drug dosing) will be entered daily and potential side-effects will also be assessed online weekly through the course of treatment. Analyses will involve mixed modeling and latent growth curve models.

The computerized intervention evaluated in this study has the potential to bridge an existing gap in knowledge translation by providing cancer survivors widespread access to CBT-I in a cost-effective manner. The study will also investigate potential short-term side-effects of online CBT-I so that patients can be fully informed when making treatment decisions. The online program could serve as the foundation of a stepped care model as recommended in the Pan-Canadian sleep guideline for adults with cancer. Overall, by reducing the burden of residual effects of cancer and its treatments, this research aims to enhance quality of life for cancer survivors in Canada and elsewhere.

The Effectiveness of Online Treatment for Insomnia in Cancer Survivors

The Effectiveness of Online Treatment for Insomnia in Cancer Survivors: A Randomized Controlled Trial

A psychometrically sound 7-item self-report measure of perceived sleep impairment. Each item is rated using a five-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28. The ISI was recently validated in a large, heterogeneous sample of cancer patients (Savard, Savard, Simard, \& Ivers, 2005).

A daily assessment of potential side-effects. The ESAS-R assesses symptoms including pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and wellbeing on a 0-10 scale. The 9-item measure created for this study includes the pain, drowsiness, depression, anxiety, and wellbeing items and adds fatigue, irritability, forgetfulness, and concentration in a format that otherwise resembles the ESAS-R.

A standardized daily outcome measure in insomnia research. Each morning respondents require 2-4 minutes to record a) the number of hours slept, b) time in bed, c) sleep onset latency (estimated time in minutes that it took to fall asleep after going to bed), and d) number of awakenings. All medications taken are also recorded. Diary data are used to calculate wake time after sleep onset (the amount of time in bed minus total sleep time and sleep onset latency) and sleep efficiency (the ratio of total sleep time to time in bed).

Comprises of 10 negative adjectives describing emotional states. Using a 5-point scale, respondents rate the extent to which each adjective is consistent with his or her current emotional state.

Self-reported current, worse, least, and average pain are each assessed. Good validity, reliability, sensitivity to change, and appropriateness to cancer pain have been reported (Jensen et al., 1999).

a 10-item self-report measure of maladaptive beliefs about sleep (e.g., beliefs about the immediate and long term negative consequences of insomnia, beliefs about the need for control over insomnia). Although developed as an analogue scale, it was transformed into a Likert-type scale with responses ranging from 1 (strongly disagree) to 6 (strongly agree). Thus, possible scores ranged from 10 to 60, with higher scores indicating more maladaptive cognitions regarding sleep. The DBAS has moderate reliability and validity (Edinger, Wohlegemuth, Radtke, Marsh, \& Quillian, 2001).

An 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. Evidence of the internal consistency, test-retest reliability, and convergent validity have been reported by the authors in their initial publication.

It consists of 5 subscales, and the authors recommend using the general fatigue subscale for investigations of overall levels of fatigue. The general fatigue (GF) subscale has been found to have good internal consistency (ranging from 0.83-0.90), and GF subscale scores have been shown to positively and significantly correlate with other self-report measures of fatigue. Scores on the sub¬scale range from 4 to 20, with higher scores indicating greater fatigue. It is frequently used with cancer patients (Smets, Garssen, Cull, \& de Haes, 1996).

A 42-item self-report measure that can be reliably grouped into three scales: anxiety, depression, and stress; however, only the depression subscale will be included for the present study. The depression subscale has demonstrated high internal consistency (Cronbach's alpha = 0.96) in a clinical sample (Brown, Chorpita, Korotitsch, \& Barlow, 1997).

A brief, 5-item scale assesses patient's perspectives of impaired functioning in important life domains. The authors report a high level of internal consistency (Cronbach's alpha = .7-.94), good test-retest reliability and sensitivity to change with treatment. Subsequent studies have confirmed its psychometric properties (Mataix-Cols et al., 2006).

A 15 item measure of subjective stress in relation to a specific stressor (e.g., cancer). It has strong psychometric properties and is frequently used in cancer research (Cella \& Tross, 1986; Cella, Mahon, \& Donovan, 1990; Thewes, Meiser, \& Hickie, 2001). The four-point frequency scale is as follows: 0='not at all', 1='rarely', 3='sometimes', 5='often', allowing the calculation of a total score (with a possible range of 0-75) and separate intrusion and avoidance subscales scores (with a possible range of 0-35 and 0-40, respectively). Research in oncology suggests a score of ≥ 40 is indicative of a significant stress response (Cella, Mahon, \& Donovan, 1990).

A 5 item questionnaire designed to measure cancer specific concerns not covered in general quality of life measures. Each item is rated using a four-point Likert scale ranging from 1 (not at all) to 4 (very much). The first three questions load on a cancer-specific worry subscale and the last two measure general health worry. Evidence of internal consistency, convergent and discriminant validity have been demonstrated in the original article. A recent intervention study provides some evidence of its sensitivity to change (Hershman et. al., 2013).

Global Quality of Life Subscale (Aaronson, Ahmedzai, \& Bergman, 1993; Osoba et al., 1997) was developed and validated with cancer patients. The global quality-of-life scale, comprised of two items rated on a Likert-type scale with responses ranging from 1 (very poor) to 7 (excellent) will be used. Scores are transformed to provide a rating ranging from 0 to 100.

With acceptable internal consistency (Cronbach's alpha = .81) and construct validity, a modified version of the five-item Medical Outcomes Study General Adherence Scale (MOS-A; Kravitz et al., 1993) assesses compliance with treatment. The MOS-A was modified by replacing physician with psychologist, and sample items are "I followed my psychologist's suggestions exactly" and "I found it easy to do the things my psychologist suggested I do." Participants respond on a scale of 1 (none of the time) to 6 (all of the time). Total scores range from 5 to 30, with higher scores reflecting greater adherence. Scores on the MOS-A have been found to correlate with adherence to other types of regimes in areas of exercise and diet (DiMatteo et al., 1993), and to negatively correlate with barriers to treatment in the area of insomnia (Vincent, Lewycky, \& Finnegan, 2008).

A four item questionnaire to assess how confident participants are that the online program helped their sleep problem, if they plan to ask for further help (e.g., in person counseling), what they liked best about the program and what they would change to make the program better.

Assesses patients' perceived global improvement. The CGI asked patients to report the overall change in their sleep and in sleep-related effects as a result of participation in their treatment. Participants are asked to rate the change in their sleep and not in any other problem such as chronic pain, depression, or anxiety. Response choices rang from very much improved (1) to very much worse (7). Evidence of the construct validity of the CGI-self-report version comes from the demonstration that CGI scores are significantly and positively associated with treatment-related changes in sleep parameters (e.g., TST, SE) (Vincent, unpublished).

Canadian Cancer Society (CCS)

University of Manitoba

Ottawa Hospital Research Institute

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.

Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Placebo taken 30 minutes before bedtime days 1-28 of treatment period

Placebo

8 mgs daily for days 1-28 of treatment period

Ramelteon

Edward J. Stepanski, Ph.D.

This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Treating Chronic Insomnia in Breast Cancer Patients

Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy

Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100\*(total sleep time divided by total time in bed).

The subject reports how many hours of sleep she got.

The subject reports how many times she woke up during the night.

The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?" with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement.

The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.

The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.

The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.

The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.

Takeda Pharmaceuticals North America, Inc.

Accelerated Community Oncology Research Network

Systematic Assessment - subjects were assessed for adverse events at each study visit by either the research coordinator, treating physician, or other appropriate sub-investigator (such as a nurse practitioner or physician assistant).

1 (Placebo)

2 (Ramelteon)

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Early study termination due to slow enrollment; Small sample size analyzed; Some IVRS and Patient Care Monitor (PCM) data were lost and could not be retrieved; Some subject non-compliance with study requirements

Vice President of Scientific Affairs

Screening Period

Treatment Period

Withdrawal Period

Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.

Sleep Efficiency

Quantitative Sleep Parameters - Total Sleep Time

Quantitative Sleep Parameters - Number of Awakenings

Complete improvement

Moderate improvement

Slight improvement

Minimal improvement

No improvement

Qualitative Evaluation of Sleep - Global Sleep Impression

Qualitative Evaluation of Sleep - Quality of Sleep

Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.

Daytime Function - Fatigue

Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.

Daytime Function - Despair

Daytime Function - Distress

Screening Period (Pre-randomization)

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

The dCBT-I group will receive full self-help dCBT-I through a smartphone APP for 6 weeks.

The wait-list group will not receive dCBT-I, waiting for treatment.At the end of the 3-month follow-up, the decision whether to receive treatment will be made according to the participants' wishes.

a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP

Digital Cognitive Behavioral Therapy for Insomnia

To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) "resleep". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.

The enrolled breast cancer survivors were randomized into two groups: the intervention group was the dCBT-I treatment group and the control group was the wait-for-treatment group.

Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial

The GAD-7 is a simple and reliable anxiety screening tool. There are a total of seven questions with a score of 0-3 for each question. The total score provides a possible score from 0-21. A score of 10 or greater indicates further evaluation is required.

The PHQ-9 is a simple and validated self-assessment scale for depressive disorders, with good reliability and validity both as an aid to the diagnosis of depression and in the assessment of symptom severity. It has a total of nine items with a total score of 0-27.

The SF-12 is a simplified version of the quality of life questionnaire generated based on the SF-36 scale, consisting of 12 items, containing eight dimensions, and assessing an individual's perceived physical and mental health status. The scale is scored on a percentage scale, and after obtaining a crude score, it is converted using the standardized scoring method. It includes the SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Higher scores indicate higher levels of quality of survival.

7)The smart bracelet data (recording parameters such as bedtime, sleep duration, number of awakenings during sleep, wake-up time, and sleep quality)

EORTC: The European Organization for Research and Treatment of Cancer; QOL-C30: Quality of Life Questionnaire Core 30.

Online sleep diary measures（total sleep time, sleep efficiency, sleep latency, numbers and duration of awakenings during sleep)

Shenzhen Zeen Health Technology Co., Ltd.

Peking University First Hospital

Pro.

Individualized homeopathy treatment as a supportive care

Homeopathy, or homeopathic medicine, is a holistic system of treatment. Individualized homeopathy remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account.C-potencies were provided and manufactured according to the Homeopathic Pharmacopoeia and Hahnemann's methodology. Each individualized homeopathic remedy were be prescribed in C-potencies

Homeopathy Medicine

Tejendra H Patel, BBA

Neha Sharma, PhD

Govind Sharma, MD

Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.

Impact of Homeopathy for Persistent Insomnia in Patients With Cancer

Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer

Center For Homeopathy Research, India

Sonal Foundation, India

Adwin Life Care

Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Healthy eating control involves a 45 minute individual session with two follow up phone calls.

Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.

Brief behavioral treatment for insomnia

Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.

Healthy Eating Control

Suzanne S. Dickerson, PhD

The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).

Brief Behavioral Treatment for Insomnia in Cancer Survivors

Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index.

The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.

Roswell Park Cancer Institute

National Institute of Nursing Research (NINR)

State University of New York at Buffalo

Principal Investigator

Brief behavioral treatment for insomnia intervention includes 45 minute individual intervention with two follow up phone calls.with 1 month followup for Insomnia Severity Index measure

Behavioral: Brief Behavioral Treatment for Insomnia

Healthy eating control involves a 45 minute individual session with two follow up phone calls with one month followup for Insomnia Severity Index measure.

Behavioral: Healthy Eating Control

Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.

Healthy eating control involves a 45 minute individual session with two follow up phone calls.

Brief behavioral treatment for insomnia: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.

Age, Continuous

the Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale. Scores from 8-14 meaures subthreshhold insomnia, 15-21 measures moderate insomnia, and 22-28 measures severe insomnia. Higher scores reflect worse outcomes.

Insomnia Severity Index

Dr Suzanne S. Dickerson

Healthy eating control involves a 45 minute individual session with two follow up phone calls with one month followup for Insomnia severity Index measure.

The main efficacy was determined at one month after the intervention. The study continued with measurements at 3 months and 12 months to determine durability. additional participants dropped out and the final numbers in the study were 60 experimental and 59 control.

Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.

Brief behavioral treatment for insomnia: Brief behavioral Managment of Insomnia content with 1 month 3 month 12 month follow-up visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of Online Treatment for Insomnia in Cancer Survivors	NCT02272712	Chronic Insomni...	Cognitive Behav...	18 Years -	Ottawa Hospital Research Institute
Treating Chronic Insomnia in Breast Cancer Patients	NCT00337272	Chronic Insomni...	Placebo Ramelteon	21 Years - 60 Years	Accelerated Community Oncology Research Network
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
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors	NCT05813392	Chronic Insomni...	Digital Cogniti...	18 Years -	Peking University First Hospital
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer	NCT02515006	Chronic Insomni... Cancer	Homeopathy Medi...	18 Years - 45 Years	Adwin Life Care
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors	NCT05813392	Chronic Insomni...	Digital Cogniti...	18 Years -	Peking University First Hospital
Brief Behavioral Treatment for Insomnia in Cancer Survivors	NCT03810365	Chronic Insomni...	Brief behaviora... Healthy Eating ...	18 Years -	State University of New York at Buffalo
Treating Chronic Insomnia in Breast Cancer Patients	NCT00337272	Chronic Insomni...	Placebo Ramelteon	21 Years - 60 Years	Accelerated Community Oncology Research Network
Treating Chronic Insomnia in Breast Cancer Patients	NCT00337272	Chronic Insomni...	Placebo Ramelteon	21 Years - 60 Years	Accelerated Community Oncology Research Network
Brief Behavioral Treatment for Insomnia in Cancer Survivors	NCT03810365	Chronic Insomni...	Brief behaviora... Healthy Eating ...	18 Years -	State University of New York at Buffalo
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer	NCT02515006	Chronic Insomni... Cancer	Homeopathy Medi...	18 Years - 45 Years	Adwin Life Care

Spots Global Cancer Trial Database for chronic insomnia