Insomnia
Conditions
Keywords
Sleep Management, Awareness Training Programs, Mindfulness Meditation, Mind Body Bridging
Brief summary
The pilot project will investigate three short-term intervention programs for sleep management in cancer survivors in a randomized controlled clinical study. Three programs to be examined in the study are: 1. the mind-body bridging program (MBBP), 2. mindfulness meditation program (MMP), and 3. sleep education program (SEP).
Detailed description
This pilot randomized study investigates whether the two awareness training programs (ATP), MBBP and MMP are effective in improving sleep disturbance and in reducing stress in post-treatment cancer patients. The two experimental conditions and the SEP control will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).
Interventions
BEHAVIORALSleep Education Program
Treatment as usual.
BEHAVIORALMind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
BEHAVIORALMindfulness Meditation Program
Mindfulness Meditation Program is based on Mindfulness-Based Stress Reduction, which teaches participants awareness and mindfulness skills using techniques that include a basic meditation practice and yoga.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Selection of subjects will be based on their exhibiting sleep disturbance as assessed by a validated sleep questionnaire (MOS Sleep Scale, Hayes et al, 2005). 2. Participant is willing to be randomized to any one of the three interventions, will be willing to attend all three classes, complete self-report questionnaires and collect saliva samples, at pre- and post- treatment, weekly intervals and 2-3 months follow-up. 3. Participant must be English speaking and comprehend information presented during the course of study, including the consent form.
Exclusion criteria
1. Underlying psychiatric illness, such as severe or untreated psychopathology (e.g. schizophrenia), or cognitive impairments, neurologic disorders, or dementia. 2. Use of psychotropic medication for any of the above, and for any other unspecified condition. 3. Has had previous exposure to MBBP or MBSR/MMP. 4. Incidence of metastatic cancer 5. Currently taking immuno-suppressants and/or corticosteroids. 6. Compromised physical health, in which individual has impaired mobility: unable to carry out movement exercises, cannot lie down on the floor, kneel, get up from the floor to a standing position. 7. Individuals who are considered at the 'end-of-life' stage of their cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical Outcomes Study-Sleep Scale | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up |
| Functional Assessment of Cancer Therapy - General | Pre-treatment, Post treatment, Follow up |
| Perceived Stress Scale | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up |
Secondary
| Measure | Time frame |
|---|---|
| Five-factor Mindfulness Questionnaire | Pre-treatment, Post treatment, Follow up |
| Impact of Event Scale | Pre-treatment, Post treatment, Follow up |
| Well-Being Index | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up |
| Self-Compassion Scale | Pre-treatment, Post treatment, Follow up |
| Center for Epidemiologic Studies Depression Scale | Pre-treatment, Post treatment, Follow up |
| Positive Affect-Negative Affect | Pre-treatment, Week 1, Week 2, Week 3, Post treatment, Follow up |
Countries
United States
Outcome results
None listed