DepressionMINDNCT01905267
Mindfulness Intervention to Study the Neurobiology of Depression
A study testing Rumination-Focused Cognitive Behavior Therapy in people with Depression, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Rumination-Focused Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between the ages of 12 and 18
- history of major depressive disorder
Who cannot join
- braces
- afraid of small spaces
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Pediatric Mood Disorders Program
Chicago, Illinois, 60608
About this study
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.
Read the detailed description
Study involves:
- Brain scan using fMRI technology
- Questions about mood and behavior
- Meeting with a clinician
- Possibility of 8 weekly treatment sessions using mindfulness
- Ongoing assessment of depression for next 2 years
Eligible participants will be compensated for their time.
- Conditions
- Depression
- Being tested
- Rumination-Focused Cognitive Behavior Therapy
- Keywords
- mindfulness, relapse prevention, recovery, depression, adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rumination-Focused Cognitive Behavior TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants randomized to the experimental condition will receive 8 weeks of individual treatment with Rumination-Focused Cognitive Behavior Therapy Receives: Behavioral: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 8 week
Secondary outcomes (1)
Change in Reynolds Adolescent Depression Scale
Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.
Measured: Baseline, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Jacobs, University of Illinois Chicago
- Investigators
- Rachel H Jacobs, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905267
- Sponsor's protocol ID
- 2012-0689
- Acronym
- MIND
- Status last verified
- Oct 2017
- First submitted
- 10 Jul 2013
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32555582Jacobs 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.
PubMed 27880789
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention to Study the Neurobiology of Depression
- ClinicalTrials.gov ID
- NCT01905267
- Acronym / sponsor ID
- MIND / 2012-0689
- Conditions
- Depression
- Keywords
- mindfulness, relapse prevention, recovery, depression, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study involves:
- Brain scan using fMRI technology
- Questions about mood and behavior
- Meeting with a clinician
- Possibility of 8 weekly treatment sessions using mindfulness
- Ongoing assessment of depression for next 2 years
Eligible participants will be compensated for their time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Rumination-Focused Cognitive Behavior TherapyParticipants 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- between the ages of 12 and 18
- history of major depressive disorder
Key exclusion criteria (2 listed)
- braces
- afraid of small spaces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rumination-Focused Cognitive Behavior TherapyThis 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. | Behavioural | Treatment |
Primary outcome
Change in Children's Depression Rating Scale - Revised
Time frame: Baseline, 8 week
clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms
1 secondary outcome
Change in Reynolds Adolescent Depression Scale
Time frame: Baseline, 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32555582Bessette 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.
- Derived from this study: PubMed 27880789Jacobs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel H Jacobs, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rumination-Focused Cognitive Behavior Therapy in people with Depression, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Depression Rating Scale - Revised (time frame: Baseline, 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.