Trial Outcomes & Findings for Mindfulness Intervention to Study the Neurobiology of Depression (NCT NCT01905267)

NCT ID: NCT01905267

Last Updated: 2018-07-30

Results Overview

clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline, 8 week
• Results posted on: 2018-07-30

Participant Flow

Participant milestones

Measure	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.	Control Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Overall Study STARTED	17	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	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.	Control Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Overall Study Physician Decision	2	2

Baseline Characteristics

Mindfulness Intervention to Study the Neurobiology of Depression

Baseline characteristics by cohort

Measure	Treatment n=17 Participants 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.	Control n=16 Participants Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study	Total n=33 Participants Total of all reporting groups
Age, Continuous	15.41 years STANDARD_DEVIATION 1.97 • n=5 Participants	15.69 years STANDARD_DEVIATION 1.89 • n=7 Participants	15.55 years STANDARD_DEVIATION 1.91 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 week

Population: completers sample

clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms

Outcome measures

Measure	Treatment n=15 Participants 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.	Control n=14 Participants Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Change in Children's Depression Rating Scale - Revised Baseline	27.47 units on a scale Standard Deviation 3.94	28.00 units on a scale Standard Deviation 6.82
Change in Children's Depression Rating Scale - Revised 8 week	25.53 units on a scale Standard Deviation 4.22	31.86 units on a scale Standard Deviation 10.99

SECONDARY outcome

Timeframe: Baseline, 8 week

Population: 8 week completers sample

Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.

Outcome measures

Measure	Treatment n=15 Participants 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.	Control n=14 Participants Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Change in Reynolds Adolescent Depression Scale Baseline	64.41 units on a scale Standard Deviation 12.12	63.50 units on a scale Standard Deviation 12.42
Change in Reynolds Adolescent Depression Scale Week 8	56.93 units on a scale Standard Deviation 13.22	61.5 units on a scale Standard Deviation 13.77

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=17 participants at risk 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.	Control n=16 participants at risk Participants randomized to the control arm will complete questionnaires and receive mood monitoring for the duration of the study
Psychiatric disorders Suicidality	0.00% 0/17 • 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	31.2% 5/16 • Number of events 5 • 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

Other adverse events

Adverse event data not reported

Additional Information

Rachel Jacobs

University of Illinois at Chicago

Phone: 3124139178

Email: rjacobs@psych.uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place