An interventional study of Body Mind Training and Cognitive Behavioral Therapy - Insomnia in Insomnia, sponsored by Rutgers, The State University of New Jersey. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Supportive care
This study focuses on improving insomnia among Hispanic cancer survivors. The three goals are to (1) culturally adapt Body-Mind Training and Cognitive Behavioral Therapy for Insomnia (CBT-I) with input from Hispanic cancer survivors, (2) determine whether the two programs are feasible and acceptable, and (3) explore whether they improve insomnia.
This study focuses on improving insomnia among Hispanic cancer survivors by adapting and testing two culturally appropriate sleep programs. First, up to 32 Hispanic cancer survivors will participate in four focus groups, with 6-8 participants per group, to provide feedback to help culturally adapt a Body-Mind Training (BMT) program and Cognitive Behavioral Therapy for Insomnia (CBT-I) in both English and Spanish. Eight of these participants will also complete individual interviews to provide additional feedback on the adapted programs. Second, 58 Hispanic cancer survivors with insomnia will participate in a randomized pilot study comparing BMT and CBT-I to determine whether the programs are feasible, acceptable, and practical for participants to complete. Third, the study will explore whether BMT and CBT-I improve insomnia, using both participant-reported insomnia symptoms and objective sleep measures collected with a wrist-worn activity monitor. Sleep will be assessed before the program, shortly after it ends, and three months later. The findings will help inform the design of a larger study comparing these approaches for treating insomnia among Hispanic cancer survivors.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 58 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Aim 1 (Cultural Adaptation):
Inclusion Criteria:
Exclusion Criteria:
Aims 2-3 (RCT):
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Body-Mind Training: A 12-week, group-based program delivered virtually twice per week. Sessions combine gentle body movements, breathing exercises, meditation, and relaxation techniques designed to support sleep and overall well-being. Participants are also encouraged to practice at home between sessions.
Behavioral: Body Mind Training
Cognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered virtually once per week. Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention. Participants are encouraged to practice the skills between sessions.
Behavioral: Cognitive Behavioral Therapy - Insomnia
Body-Mind Training (BMT): A 12-week, group-based program delivered by live videoconference twice per week for 60 minutes. Each session includes a warm-up, gentle body movements combined with meditation, breathing techniques, and relaxation exercises. Movements can be completed while seated or standing to support participant safety and different physical abilities. Participants will also receive instructional videos and a manual to support home practice and will be encouraged to practice for at least 30 minutes, three days per week. The final four weeks of the program will emphasize skill consolidation and continued practice.
Cognitive Behavioral Therapy for Insomnia (CBT-I): An 8-week, group-based program delivered by live videoconference once per week for 60 minutes by a licensed bilingual psychologist experienced in CBT-I. Sessions include sleep education, sleep restriction, stimulus control, cognitive therapy, relaxation, sleep hygiene, and relapse prevention. Participants will be encouraged to practice the skills learned during sessions for at least 30 minutes per day, three days per week.
Insomnia Severity Index
Insomnia will be assessed with the Insomnia Severity Index (ISI). A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Recruitment Rate
We hypothesize that at least 50% of eligible individuals approached for the study will enroll.
Time frame: 1-2 weeks post-intervention
Follow-up retention rate
We hypothesize that ≥80% of participants will complete the 1-week post-intervention assessment and ≥70% will complete the 3-month post-intervention assessment.
Time frame: 1-2 weeks post-intervention
Actigraphy adherence rate
We hypothesize that ≥80% of participants will collect ≥75% of actigraphy data
Time frame: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Physical activity and sleep logs adherence rate
we hypothesize that )≥70% of participants will complete ≥75% of activity \& sleep logs.
Time frame: baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Acceptability
Acceptability will be assessed using the Treatment Perceptions Questionnaire (TPS). Participants will rate the comprehensibility of components of the culturally appropriate interventions, as well as their length, intensity, and overall suitability for reducing sleep-quality impairment. The TPQ is available in Spanish and English. We hypothesize that ≥80% of participants will find the intervention was acceptable
Time frame: 1-2 weeks post-intervention
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used, validated 19-item self-report measure of sleep quality over the past month. It yields a global score ranging from 0-21, with higher scores indicating poorer sleep quality and scores \>5 indicating clinically significant sleep disturbance. The PSQI has demonstrated good internal consistency (Cronbach's α = 0.83), test-retest reliability, and construct validity.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Sleep self-efficacy
Sleep self-efficacy will be measured with the sleep self-efficacy scale(SES). The SES is a 9-item self-report measure that assesses anindividual's confidence in their ability to achieve and maintain healthysleep. Items are rated on a 5-point Likert scale, with higher scoresindicating greater sleep self-efficacy.106 The SES has demonstratedexcellent internal consistency (Cronbach's α ≈ 0.90).
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Mindfulness
Mindfulness will be measured with the Mindful Attention Awareness Scale (MAAS), a 15-item self-report measure that assesses dispositional mindfulness, specifically an individual's awareness of and attention to present-moment experiences. Items are rated on a 6-point Likert scale, with higher scores indicating greater mindfulness. The MAAS has demonstrated excellent internal consistency (Cronbach's α =0.80-0.90) and strong construct validity and is available in both English and Spanish
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Physical Activity Level
Differences in physical activity outside theintervention will be assessed with the Godin-Shephard Leisure-TimePhysical Activity Questionnaire. This questionnaire is available andvalidated in English and Spanish.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Quality of Life (QOL)
Quality of Life (QOL) will be assessed via the Functional Outcomes for Cancer Therapy - General (FACT-G). This measure consists of 27 items designed to measure four domains of quality of life in cancer patients: physical, social, emotional, and functional well-being. Coefficients of reliability and validity are uniformly high. The scale's ability to discriminate among patients based on disease stage, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. The FACT-G is available and validated in English and Spanish.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Anxiety and Depressive Symptoms
Anxiety and depression will be measured with the Patient Health Questionnaire-4 (PHQ-4), a 4-item self-report measure that assesses symptoms of anxiety and depression over the past two weeks. It combines the 2-item Generalized Anxiety Disorder scale (GAD-2) and the 2-item Patient Health Questionnaire (PHQ-2), with higher scores indicating greater psychological distress. The PHQ-4 has demonstrated good internal consistency (Cronbach's α ≈ 0.81) and strong validity and is available in both English and Spanish.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Perceived Stress
Perceived stress will be measured with the Perceived Stress Scale (PSS-10), a 10-item self-report measure that assesses the degree to which individuals perceive their lives as stressful during the past month. Items are rated on a 5-point Likert scale, with higher scores indicating greater perceived stress. The PSS-10 has demonstrated good internal consistency (Cronbach's α ≈ 0.78-0.91), strong construct validity, and is available in both English and Spanish.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Fatigue
Fatigue will be assessed with the Functional Assessment of Chronic Illness - Fatigue (FACIT-F) Scale.120 This scale is frequently used with cancer survivors because it has established minimally important differences. This 13-item scale assesses the level of fatigue during usual activities over the past 7 days, with higher scores indicating less fatigue (score range=0-52; Cronbach's alpha=0.86). The FACIT-F is available in English and Spanish and validated in Spanish-speaking populations.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Comorbidities
Comorbidities will be assessed with the Charlson Comorbidity Index. It is a weighted index that considers both the number and the seriousness of comorbid diseases. It consists of 19 items, each with an assigned weight from 1 to 6 according to the relative risk of dying within a year. In general, the absence of comorbidity is considered: 0-1 points; low comorbidity: 2 points; and high comorbidity:≥3 points.
Time frame: Baseline
Acculturation
Acculturation will be measured with the Short Acculturation Scale for Hispanics (SASH). The 12-item scale (explaining 67.6% of the variance for Hispanics) correlates highly with the following validation criteria: respondents' generation, length of residence in the U.S., age at arrival, ethnic self-identification, and an acculturation index. The SASH is available and validated in English and Spanish.
Time frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention
Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy
Actigraphy will measure the number of minutes of actual sleep.
Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
Objective Symptoms of Insomnia- Sleep Efficiency via Actigraphy
Actigraphy will measure the percent of time actually slept compared to intended time sleeping.
Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy
Actigraphy will measure the minutes it takes for the participant to fall asleep.
Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy
Actigraphy will measure total minutes of wake time after sleep onset.
Time frame: 3 weeks (worn for 1 week at Baseline, 1-2 weeks post-intervention, and 3-months post-intervention)
Perceived exertion
Perceived exertion will be measured after each BMT session, with the classic Borg Rating of Perceived Exertion (RPE) scale, which is a 15-point scale (ranging from 6 to 20). It has been extensively tested and validated against physiological markers. This will be collected to ensure that the BMT intervention is perceived as being of mild to moderate intensity.
Time frame: Within 24 hours after each BMT session, up to 24 sessions over 12 weeks.
Treatment Credibility and Expectancy
Credibility/Expectancy Questionnaire (CEQ). The CEQ is a brief 6-item self-report measure assessing participants' perceived credibility of an intervention and expectations for improvement. It has demonstrated good internal consistency, with Cronbach's α generally ranging from 0.79-0.90 for credibility and 0.81-0.86 for expectancy, as well as good test-retest reliability.
Time frame: During the first week of the intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jul 2031, 54 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 54 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Jan 2027, on Nov 10, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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