This is a prospective study that will examine psychosocial improvements among CF adolescents and caregivers going through the Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
Massachusetts General Hospital
Boston, Massachusetts, United States
Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The 14-Item Resiliency Scale (RS-14)
The RS-14 measures stress coping ability in the face of adversity.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Satisfaction with Life (SWL)
The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Perceived Stress Scale (PSS-10)
The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS-A)
The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.
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Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire (PHQ) - caregivers only
The PHQ measures symptoms of depression and functional impairment.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire for Adolescents (PHQ-A) - patients only
Symptoms of depression and functional impairment
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Generalized Anxiety Disorder 7-item (GAD-7)
A brief measure for assessing generalized anxiety disorder
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Cognitive and Affective Mindfulness Scale (CAMS) - caregivers only
The CAMS measures the degree to which individuals experience their thoughts and feelings.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Child and Adolescent Mindfulness Measure (CAMM) - patients only
Assesses mindfulness in children and adolescents
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Interpersonal Reactivity Index (IRI)
The IRI assesses the cognitive and affective dimensions of empathy.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Distress Analogue Scales
The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Gratitude Questionnaire (GQ-6)
The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale
The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Medical Outcomes Study (MOS) Social Support Survey
The MOS Social Support Survey measures various dimensions of social support.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Rosenberg Self Esteem Scale (RES)
Assesses levels of self esteem
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Body Image Quality of Life Inventory (BIQLI) - patients only
Measures patients' perception of their own body image and how it relates to quality of life.
Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)