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The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a research study examining how mindfulness can help teenagers stay healthy and prevent depression relapse.
Study involves:
Eligible participants will be compensated for their time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy |
|
| Control | No Intervention | Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rumination-Focused Cognitive Behavior Therapy | Behavioral | This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Children's Depression Rating Scale - Revised | clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms | Baseline, 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reynolds Adolescent Depression Scale | Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms. | Baseline, 8 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel H Jacobs, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago Pediatric Mood Disorders Program | Chicago | Illinois | 60608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32555582 | Derived | Bessette KL, Jacobs RH, Heleniak C, Peters AT, Welsh RC, Watkins ER, Langenecker SA. Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial. PLoS One. 2020 Jun 17;15(6):e0233539. doi: 10.1371/journal.pone.0233539. eCollection 2020. | |
| 27880789 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length. |
| FG001 | Control | Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Children's Depression Rating Scale - Revised | clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms | completers sample | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 week |
|
two years following 8 week intervention period every six months
Study staff informed of hospitalizations for suicidality or increasing depressive symptoms during course of KSADS clinical assessments
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy Rumination-Focused Cognitive Behavior Therapy: This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidality | Psychiatric disorders | Non-systematic Assessment | Five participants were hospitalized for suicidality or suicidal gestures. |
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Small number of subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Jacobs | University of Illinois at Chicago | 3124139178 | 312 | rjacobs@psych.uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2014 | Aug 3, 2017 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 30, 2014 | Aug 3, 2017 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2014 | Sep 13, 2017 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| 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. |
| BG001 | Control | Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control | Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study |
|
|
| Secondary | Change in Reynolds Adolescent Depression Scale | Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms. | 8 week completers sample | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 week |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Control | Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study | 0 | 16 | 5 | 16 | 0 | 16 |
|
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