Depression Clinical Trial
— CBTeXOfficial title:
Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 30, 2027 |
Est. primary completion date | January 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - Female - Age 12-17 years - Body Mass Index (BMI)>= 85 for age and sex - Type 2 Diabetes (T2D) first-or second-degree relative - Center for Epidemiologic Studies Depression Scale (CES-D) total score >=21 Exclusion Criteria: - T2D/ Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training - Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) conduct disorder, substance abuse/ dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia/bulimia, & schizophrenia - Regular medication use affecting mood, insulin, or weight, including stimulants, anti-depressants, anti-psychotics, insulin sensitizers, weight loss medications & chronic steroids - Regular psychotherapy, structured weight loss treatment, or bariatric surgery - Pregnancy, nursing |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Colorado State University | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dispositional mindfulness | Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score | 1-year | |
Other | Weight bias internalization | Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score | 1-year | |
Other | Body image | Multidimensional Body Self-Relations Questionnaire Measure composed of 10 subscales: appearance evaluation, fitness evaluation, fitness orientation, health evaluation, health orientation, illness orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. | 1-year | |
Other | Automatic thoughts | Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores | 1-year | |
Other | Pleasant activities | Adolescent report on the frequency and perceived pleasantness of physical and social activities on the Pleasant Events Schedule (PES), frequency and pleasantness scales for physical activities and for social activities | 1-year | |
Other | Intervention Acceptability | Equal or greater than 80% adolescent liking/credibility ratings (equal or greater than 4 on a scale of 1=not at all to 5=extremely) on a Program Acceptability Questionnaire and themes indicative of liking/perceived benefit on standardized interviews for qualitative coding | 1-year | |
Primary | Insulin Resistance | Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing | 1-year | |
Secondary | Insulin sensitivity | Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing | 1-year | |
Secondary | Cardiorespiratory fitness | Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion | 1-year | |
Secondary | Rate Perceived Exertion | Adolescent report on the Borg Scale during cycle ergometry testing | 1-year | |
Secondary | Exercise enjoyment | Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score | 1-year | |
Secondary | Exercise self-efficacy | Adolescent report on the Exercise Self-Confidence Survey, total score | 1-year | |
Secondary | Exercise perceived capability | Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form | 1-year | |
Secondary | Depression symptoms | Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score | 1-year | |
Secondary | Depressive disorder | Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent | 1-year | |
Secondary | Eating behavior | Habitual macronutrient/food group intake reported 3 days (2 weekdays, 1 weekend) on the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | 1-year | |
Secondary | Sleep quality | Adolescent report on the Pittsburgh Sleep Quality Index, total score | 1-year | |
Secondary | Sleep disturbance | Adolescent report on the Insomnia Severity Index, total score | 1-year | |
Secondary | BMI | Derived from height in triplicate by stadiometer and fasting weight by calibrated scale; raw (kg/m2) and z-score/percentile based upon Centers for Disease Control and Prevention (CDC) growth charts | 1-year | |
Secondary | Adiposity | Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod) | 1-year |
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