CBTeX: Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes

Sponsor

Colorado State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05543083

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Colorado, Denver (Other)

300

Enrollment

Arms

54.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Depression Depressive Disorder Mood Disorders Mental Disorder in Adolescence Hyperinsulinism Glucose Metabolism Disorders Metabolic Disease	Behavioral: Cognitive-Behavioral Therapy followed by Exercise Training Behavioral: Exercise Training followed by Cognitive-Behavioral Therapy Behavioral: Cognitive-Behavioral Therapy Only Behavioral: Exercise Training Only	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes

Anticipated Study Start Date :

Sep 16, 2022

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive-Behavioral Therapy followed by Exercise Training 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 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. Other Names: CBT->Exercise Training
Active Comparator: Exercise Training followed by Cognitive-Behavioral Therapy 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 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. Other Names: Exercise Training -> CBT
Active Comparator: Exercise Training Only 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 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. Other Names: CBT Only
Active Comparator: 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 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.

Outcome Measures

Primary Outcome Measures

Insulin Resistance [1-year]
Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing

Secondary Outcome Measures

Insulin sensitivity [1-year]
Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing
Cardiorespiratory fitness [1-year]
Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion
Rate Perceived Exertion [1-year]
Adolescent report on the Borg Scale during cycle ergometry testing
Exercise enjoyment [1-year]
Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score
Exercise self-efficacy [1-year]
Adolescent report on the Exercise Self-Confidence Survey, total score
Exercise perceived capability [1-year]
Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form
Depression symptoms [1-year]
Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
Depressive disorder [1-year]
Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent
Eating behavior [1-year]
Habitual macronutrient/food group intake reported 3 days (2 weekdays, 1 weekend) on the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Sleep quality [1-year]
Adolescent report on the Pittsburgh Sleep Quality Index, total score
Sleep disturbance [1-year]
Adolescent report on the Insomnia Severity Index, total score
BMI [1-year]
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
Adiposity [1-year]
Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod)

Other Outcome Measures

Dispositional mindfulness [1-year]
Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score
Weight bias internalization [1-year]
Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score
Body image [1-year]
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.
Automatic thoughts [1-year]
Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores
Pleasant activities [1-year]
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
Intervention Acceptability [1-year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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