An interventional study of Cognitive-Behavioral Therapy followed by Exercise Training and Exercise Training followed by Cognitive-Behavioral Therapy in Insulin Resistance, Depression and Depressive Disorder, sponsored by Colorado State University. Recruiting at 2 sites in United States. Open to female participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Colorado State University · Not applicable, Interventional, and Prevention
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.
There has been rapid escalation in adolescent-onset type 2 diabetes (T2D), particularly in females from historically disadvantaged racial/ethnic groups. Prevention is critical because adolescent-onset T2D often shows a more aggressive disease course than adult-onset, and effective treatment options remain elusive. Standard-of-care for T2D prevention includes exercise training to ameliorate insulin resistance, a key physiological precursor to T2D. Despite short-term benefits, exercise training shows insufficient effectiveness in adolescents at-risk for T2D. Depression may be explanatory in a considerable subset of teenagers. Adolescence is notable for increases in depression and decreases in physical activity, especially in females with obesity. Youths' depression symptoms contribute to worsening insulin resistance over time, independent of BMI (kg/m2), likely through stress-mediated pathways such as reduced physical activity and fitness. Also, adolescent depression is associated with decreased physical activity and cardiorespiratory fitness, even after accounting for adiposity, and depression predicts greater non-adherence to exercise training. The central theme of this proposal is that an intervention sequence of delivering cognitive-behavioral therapy (CBT) first, followed by intervening with exercise training second, will offer a targeted, efficacious strategy for improving insulin resistance and consequently, lowering T2D risk in adolescent females at-risk for T2D with depression symptoms. In a prior National Institute of Health (NIH) /National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K99/R00 randomized controlled trial (RCT), the investigators found that 6-week group CBT decreased depression at 6-week follow-up in adolescent females at-risk for T2D with moderately elevated depression, compared to a 6-week didactic health education control group. Adolescents with elevated depression who were randomized to CBT had lower fasting and 2-hour insulin at 1-year vs. controls. Our preliminary data suggest that CBT's focus on enhancing frequency/enjoyment of physical activity to combat depressed mood partially explained why decreasing depression lowered T2D risk. It is not known if CBT is just as efficacious as standard-of-care exercise training, or whether CBT followed by exercise training results in a maximally potent alleviation of T2D risk in adolescent females at-risk for T2D with depression symptoms. To address these gaps and directly build on our prior work, the investigators propose a four-arm RCT to: (1) Compare the efficacy of four 6-week-->6-week sequences for improving insulin resistance in N=300 adolescent females at-risk for T2D with elevated depression symptoms: (i) CBT-->exercise, (ii) exercise-->CBT, (iii) CBT only (CBT-->continue CBT), and (iv) exercise only (exercise-->continue exercise); (2) Evaluate physical activity/fitness as mediators underlying the depression-insulin resistance association; and (3) Evaluate underlying mechanisms by which decreasing depression increases physical activity and improves fitness and insulin resistance using a mixed-methods process evaluation. Findings will support our long-term goal to identify feasible, cost-effective intervention strategies with high potential for effective dissemination to adolescents at-risk for T2D with elevated depression symptoms.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's planned enrollment of 300 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by a 6-week exercise training intervention of 6 weekly 1-hour group sessions
Behavioral: Cognitive-Behavioral Therapy followed by Exercise Training
6-week exercise training intervention of 6 weekly 1-hour group sessions followed by a 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions
Behavioral: Exercise Training followed by Cognitive-Behavioral Therapy
6-week exercise training intervention of 6 weekly 1-hour group sessions followed by an additional 6-week exercise training intervention of 6 weekly 1-hour group sessions
Behavioral: Cognitive-Behavioral Therapy Only
6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by an additional 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions
Behavioral: Exercise Training Only
6-week group CBT (cognitive-behavioral therapy; 1 hour/week for 6 weeks) followed by 6-week group exercise training (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.
Also known as: CBT->Exercise Training
6-week group exercise training (1 hour/week for 6 weeks) followed by 6-week group CBT (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.
Also known as: Exercise Training -> CBT
6-week group CBT (1 hour/week for 6 weeks), with continuation of group CBT for a second 6-week period (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.
Also known as: CBT Only
6-week group exercise training (1 hour/week for 6 weeks), with continuation of group exercise for a second 6-week period (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.
Insulin Resistance
Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing
Time frame: 1-year
Insulin sensitivity
Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing
Time frame: 1-year
Cardiorespiratory fitness
Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion
Time frame: 1-year
Rate Perceived Exertion
Adolescent report on the Borg Scale during cycle ergometry testing
Time frame: 1-year
Exercise enjoyment
Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score
Time frame: 1-year
Exercise self-efficacy
Adolescent report on the Exercise Self-Confidence Survey, total score
Time frame: 1-year
Exercise perceived capability
Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form
Time frame: 1-year
Depression symptoms
Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
Time frame: 1-year
Depressive disorder
Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent
Time frame: 1-year
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)
Time frame: 1-year
Sleep quality
Adolescent report on the Pittsburgh Sleep Quality Index, total score
Time frame: 1-year
Sleep disturbance
Adolescent report on the Insomnia Severity Index, total score
Time frame: 1-year
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
Time frame: 1-year
Adiposity
Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod)
Time frame: 1-year
Dispositional mindfulness
Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score
Time frame: 1-year
Weight bias internalization
Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score
Time frame: 1-year
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.
Time frame: 1-year
Automatic thoughts
Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores
Time frame: 1-year
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
Time frame: 1-year
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
Time frame: 1-year
Started Jun 2023 (actual). Primary completion is estimated for Dec 2028, 66 months after the start.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 66 months is above that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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