Mechanisms of Rumination Change in Adolescent Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-17
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rumination-Focused CBT
BehavioralRF-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.
Relaxation-based Therapy
BehavioralSessions 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.
Treatment groups
183 Participants
are divided into 3 treatment groupsGroup A: Rumination-Focused CBTExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Group C: Relaxation-based therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rumination Responsiveness Scale (RRS)
RRS is a scale developed by Dr. Susan Nolan-Hoeksema that is used to determine pre-post reductions in rumination after RF-CBT. The RRS is the Rumination Responsiveness Scale. Scores range from a low of 22 to a high of 88 on the 232 item scale. Higher scores indicate more difficulties with rumination. Higher rumination has been reported in a number of samples of both active and remitted MDD. The outcome is a reliable change index decline of at least 1/2 standard deviation in the RF-CBT group relative to the AO and RelaxT arms. In our preliminary study, the RRS declined from 52.88 to 43 (Jacobs et al., 2016). An age matched control group had a mean score of 30.4 (7.1), Burkhouse et al., 2016.
Time frame
~14-22 weeks2
Resting state functional magnetic resonance imaging (fMRI) connectivity of Default mode network to cognitive control network.
Using seed based approaches with the posterior cingulate gyrus and medial prefrontal cortex, the investigators will evaluate if RF-CBT and not AO or RelaxT, results in decreases in rs-fMRI connectivity to cognitive control network nodes, particularly right inferior frontal and temporal gyri.
Time frame
~14-22 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
University of Exeter
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
University of Utah
Collaborator
Nationwide Children's Hospital
Collaborator
Utah Center for Evidence Based Treatment
Collaborator
Source ClinicalTrials.gov