Developing and Testing of Behavioral Intervention Programs for Hispanic Cancer Survivors With Insomnia

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07800715
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Body Mind Training — BEHAVIORAL
    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 - Insomnia — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 2, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Body Mind Training
    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.
  • Experimental: Cognitive Behavioral Therapy - Insomnia
    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.

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: Baseline, 1-2 weeks post-intervention, and 3 months post-intervention ]

Central Contacts

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