Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R61MH116080 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Exeter | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| University of Utah | OTHER |
| Nationwide Children's Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
The Investigators determine if the child is eligible (see criteria below for 14-17 year olds with history of MDD.
The Investigators complete pre-intervention assessments with the child that include
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.
repeat assessments after the intervention period. The cognitive skills and emotion processing are also assessed during the middle of the intervention period.
follow-up assessments to determine any changes, recurrence of depression, new treatments for the next two years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rumination-Focused CBT | Experimental | RF-CBT is a manual-based treatment for prevention of depression, includes focus on ruminations, mental habits, concreteness training, and mindfulness. |
|
| Treatment as Usual | No Intervention | Participants are allowed to continue any therapy outside of the treatment study. | |
| Relaxation-based therapy | Active Comparator | RelaxT includes an active comparison treatment that can be used to monitor and modify physiological responses to stress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rumination-Focused CBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ~14-22 weeks |
| 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. | ~14-22 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
all gender representations are allowed.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott A Langenecker, Ph.D. | Contact | 734-276-3889 | scott.langenecker@osumc.edu | |
| Caty Escobar, M.S. | Contact | 301-648-3426 | caty.escobar@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scott Langenecker, Ph.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21778171 | Background | Watkins ER, Mullan E, Wingrove J, Rimes K, Steiner H, Bathurst N, Eastman R, Scott J. Rumination-focused cognitive-behavioural therapy for residual depression: phase II randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):317-22. doi: 10.1192/bjp.bp.110.090282. Epub 2011 Jul 21. | |
| 27921216 | Background | Burkhouse KL, Jacobs RH, Peters AT, Ajilore O, Watkins ER, Langenecker SA. Neural correlates of rumination in adolescents with remitted major depressive disorder and healthy controls. Cogn Affect Behav Neurosci. 2017 Apr;17(2):394-405. doi: 10.3758/s13415-016-0486-4. |
Not provided
Not provided
All de-identified data relevant to the clinical trial and primary R61/R33 targets will be release biannually per requirements of the NIH policy, the request for application (RFA) and consistent with HIPAA and Institutional Review Board (IRB) approval at the University of Utah and the University of Exeter. In addition to the data for the clinical trial specifically, demographic and clinical information will be included.
Data will be shared in line with Resource Sharing guidelines for this specific RFA
Available to researchers, after appropriate data sharing agreements have been made with the University of Utah.
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| D000079562 | Rumination Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001523 | Mental Disorders |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| OTHER |
| Utah Center for Evidence Based Treatment | UNKNOWN |
First two years. randomization to either rumination-focused cognitive behavioral therapy (RF-CBT) or Assessment only (AO) for a 10 week intervention period.
Last three years. randomization to either rumination-focused cognitive behavioral therapy (RF-CBT) or Relaxation therapy (RelaxT) for a 10 week intervention period.
Not provided
Not provided
Not provided
|
| Relaxation-based Therapy | Behavioral | 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. |
|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| 26260780 | Background | Hvenegaard M, Watkins ER, Poulsen S, Rosenberg NK, Gondan M, Grafton B, Austin SF, Howard H, Moeller SB. Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. Trials. 2015 Aug 11;16:344. doi: 10.1186/s13063-015-0875-y. |
| 24661156 | Background | Watkins ER, Nolen-Hoeksema S. A habit-goal framework of depressive rumination. J Abnorm Psychol. 2014 Feb;123(1):24-34. doi: 10.1037/a0035540. |
| 23866301 | Background | McEvoy PM, Watson H, Watkins ER, Nathan P. The relationship between worry, rumination, and comorbidity: evidence for repetitive negative thinking as a transdiagnostic construct. J Affect Disord. 2013 Oct;151(1):313-20. doi: 10.1016/j.jad.2013.06.014. Epub 2013 Jul 16. |
| 27880789 | Result | Jacobs RH, Watkins ER, Peters AT, Feldhaus CG, Barba A, Carbray J, Langenecker SA. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI. PLoS One. 2016 Nov 23;11(11):e0163952. doi: 10.1371/journal.pone.0163952. eCollection 2016. |
| 35268378 | Result | Dillahunt AK, Feldman DA, Thomas LR, Farstead BW, Frandsen SB, Lee S, Pazdera M, Galloway J, Bessette KL, Roberts H, Crowell SE, Watkins ER, Langenecker SA, Westlund Schreiner M. Self-Injury in Adolescence Is Associated with Greater Behavioral Risk Avoidance, Not Risk-Taking. J Clin Med. 2022 Feb 26;11(5):1288. doi: 10.3390/jcm11051288. |
| 42387276 | Derived | Thompson MB, Thomas LR, Westlund Schreiner M, Kingston NH, Ollech H, Kalotihos L, Escobar C, Wagh U, Pazdera M, Kaufman EA, Crowell SE, Roberts H, Bessette KL, Langenecker SA, Watkins ER. Tracking Rumination as a Stable Habit (TRASH); Scale Modification and Convergent Validity in a Clinical Sample of Youth With a History of Depression. Psychol Rep. 2026 Jul 1:332941261464085. doi: 10.1177/00332941261464085. Online ahead of print. |
| 33892684 | Derived | Roberts H, Jacobs RH, Bessette KL, Crowell SE, Westlund-Schreiner M, Thomas L, Easter RE, Pocius SL, Dillahunt A, Frandsen S, Schubert B, Farstead B, Kerig P, Welsh RC, Jago D, Langenecker SA, Watkins ER. Mechanisms of rumination change in adolescent depression (RuMeChange): study protocol for a randomised controlled trial of rumination-focused cognitive behavioural therapy to reduce ruminative habit and risk of depressive relapse in high-ruminating adolescents. BMC Psychiatry. 2021 Apr 23;21(1):206. doi: 10.1186/s12888-021-03193-3. |
| D001068 | Feeding and Eating Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |