Mechanisms of Rumination Change in Adolescent Depression — RuMeChange  

Major Depressive Disorder Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders

• NCT number: NCT03859297
• Study type: Interventional
• Source: University of Utah
• Contact: Scott A Langenecker, Ph.D.
• Phone: 801-213-1200
• Email: s.langenecker@hsc.utah.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Completion date: March 2, 2026