NCT03859297

Mechanisms of Rumination Change in Adolescent Depression

Developing Rumination-focused Treatment to Reduce Risk for Depression Recurrence (RDR) in Adolescence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether a newer treatment, rumination-focused cognitive behavioral treatment, which includes mindfulness and can be used to reduce ruminative habits, change ways in which key brain regions interact with each other (e.g.., often called connectivity), and whether these changes in habits and brain connectivity can reduce the risk for recurrence of depression in the next two years.

Detailed description

Major Depressive Disorder (MDD) is a disease that has it's onset in childhood and early adolescence for many. Treatments in adolescence tend to be acute and short-term. Unfortunately, between half and three quarters of adolescents who have a first episode of MDD will go to have a second episode within the next two years. Studies in adults suggest that maintenance treatments or preventative treatments can lower these risks and delay or stop recurrences. The present study will use a preventative strategy, rumination-focused CBT (RF-CBT) to delay or stop the onset of another MD episode for at least two years. For the first 2 years of the study, adolescents with a history of MDD who are currently well will be randomly selected for either treatment with RF-CBT or just treatment as usual in the first two years of the study. In the last 3 years of the study, these adolescents will be randomized to either RF-CBT or Relaxation Therapy above and beyond TAU (Treatment as Usual). Brain, cognitive, and self-report measurements are collected before during and after the intervention to evaluate what brain and rumination changes occur, and which adolescents benefit the most from the treatment. What will happen. 1. The Investigators determine if the child is eligible (see criteria below for 14-17 year olds with history of MDD. 2. The Investigators complete pre-intervention assessments with the child that include 1. brain imaging 2. tests of cognitive skills and emotion processing, including rumination 3. questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian 4. measurement of sleep using a handheld wristwatch (called an actigraph - optional). 3. randomization (chance assignment) in years 1-2 to either rumination focused cognitive behavioral therapy (RF-CBT) or assessment only for a 10-14 session intervention. Treatment as usual continues for all adolescents. In years 3-5, chance assignment is to RF-CBT or Relaxation Therapy. 4. repeat assessments after the intervention period. The cognitive skills and emotion processing are also assessed during the middle of the intervention period. 1. brain imaging 2. tests of cognitive skills and emotion processing, including rumination 3. questionnaires about how the adolescent thinks and responds to situations, similar questionnaires in at least one parent/guardian 4. measurement of sleep using a handheld wristwatch (called an actigraph - optional). 5. follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years. 1. questionnaires 2. interviews

Conditions

• Major Depressive Disorder
• Mood Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Rumination-Focused CBT	RF-CBT targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effectively coping with rumination. RF-CBT specifically targets rumination through psychoeducation, adopting a functional analytic approach to the learned habitual behavior of rumination, and a focus on shifting process style. The adolescent is taught to notice triggers to ruminate as well as the consequences of rumination and to shift into practicing a more adaptive strategy such as an attention training exercise, behavioral activation, thinking in a concrete way, or active problem-solving. RF-CBT directly teaches adolescents to recognize rumination or "when the participant gets stuck in their head" and to notice the influence this has on their mood.
BEHAVIORAL	Relaxation-based Therapy	Sessions will include progressive muscle relaxation, simple breathing techniques, and guided imagery that focus on bodily and somatic relaxation. Adolescents randomized to Relaxation Therapy (RelaxT) will also receive exercises to do as homework in between sessions, parallel to the RF-CBT group.

Timeline

• Start date: 2019-05-01
• Primary completion: 2028-04-14
• Completion: 2029-03-02
• First posted: 2019-03-01
• Last updated: 2025-08-11

Locations

3 sites across 1 country: United States