Evaluating a new treatment for adolescent depression
Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence
This study is testing a new therapy for teenagers with a history of depression to see if it can help prevent them from feeling depressed again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 183 (estimated) |
| Ages | 14 Years to 17 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 3 sites (Columbus, Ohio and 2 other locations) |
| Trial ID | NCT03859297 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of rumination-focused cognitive behavioral therapy (RF-CBT) in preventing recurrence of major depressive disorder (MDD) in adolescents aged 14-17. Participants with a history of MDD will be randomly assigned to receive RF-CBT or treatment as usual for the first two years, followed by a comparison of RF-CBT and relaxation therapy in the subsequent three years. The study will assess changes in brain connectivity and cognitive patterns through brain imaging and self-report measures to determine the treatment's impact on reducing ruminative habits and preventing future depressive episodes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 14-17 with a history of major depressive disorder who are currently in remission.
Not a fit: Patients with active suicidality or severe conduct disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent depression in adolescents, improving their long-term mental health outcomes.
How similar studies have performed: Previous studies have shown promise in using cognitive behavioral therapies for depression, suggesting that this approach may be effective, though the specific focus on rumination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previous diagnosis of Major Depressive Disorder (full or partial remission for at least two weeks) according to Diagnostic and Statistical Manual (DSM-V) criteria confirmed by the Kiddie Schedule for affective disorders (KSADSPL). Partial remission is defined as not meeting full DSM-V criteria for MDD. * RRS score above the age and sex specific mean, T \> 50). * 14-17 years of age at enrollment (accounting for 2 year follow-up), * Postpubertal (Petersen Pubertal Developmental Scale) * Youth assent and parent consent * Intellectual Quotient (IQ) \> 75, determined by Wechsler Abbreviated Scale of Intelligence (WASI) Exclusion Criteria: * Endorsement of suicidality with plan or intent (assessed via KSADSPL and Children's Depression Rating Scale (CDRS-R) clinical interviews. Current or past (within previous three months) plan or intent is exclusionary. * Lifetime history of conduct disorder, autism, any psychotic disorder (or episode unexplained by other known medical causes), or bipolar disorder. Eating disorder or alcohol/substance abuse within the previous 6 months. (Lifetime history of an anxiety disorder, disruptive mood dysregulation disorder or oppositional defiant disorder, Attention Deficit Hyperactivity Disorder (ADHD) will not be exclusionary). * Current treatment with RF-CBT, Cognitive Behavioral Therapy (CBT), or variants thereof, or in the last 2 years. Likewise, detail oriented therapy beyond supportive therapy (e.g., homework, cognitive restructuring), in same time window (ability to recall elements of structured therapies with CBT focus). * Metal braces or retainers, tattoos with metal, or clothing with metal fibers. * Claustrophobia * Current pregnancy - Parents will be asked this information at the phone screen. At the clinic eligibility visit, female participants will be asked about sexual activity in a private room separate from their parents using the pregnancy script/screen that the investigators have created. This script details that if a female is ineligible due to pregnancy or inadequate birth control, this information will not be disclosed to her parent(s). Participants who are sexually active will be asked about birth control method. Abstinence will be considered an approved form of contraception. * Psychotropic medication outside of antidepressants such as mood stabilizers and antipsychotics will be exclusionary. Participants may have a history of current, stable antidepressant medication use, with no changes in dose for the past four weeks, no change in specific medication for six weeks.
Where this trial is running
Columbus, Ohio and 2 other locations
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Scott Langenecker, Ph.D. — Ohio State University
- Study coordinator: Scott A Langenecker, Ph.D.
- Email: scott.langenecker@osumc.edu
- Phone: 734-276-3889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.