Mood DisordersNCT05070052
MBCT and CBT for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial
A study testing cognitive behavioral therapy and mindfulness-based cognitive therapy in people with Mood Disorders and Prodromal Symptoms, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The present study is a randomized controlled trial comparing the efficacy and acceptability of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood or psychotic disorder onset or relapse. Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Mood Disorders, Prodromal Symptoms, Bipolar Disorder
- What is being tested?
- cognitive behavioral therapy and mindfulness-based cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 9 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient meets criteria for having experienced a (past or present) disorder marked by clinically significant mood instability, depression, and/or psychotic features (i.e., diagnosed with a mood disorder, adjustment disorder with depressed mood, or psychotic disorder) OR they are at clinical high risk for psychosis
Who cannot join
- Patient's current severity of illness interferes with participation in a group treatment (e.g., preoccupied with internal stimuli)
- Patient has a current substance use disorder
- Patient has a pervasive developmental disorder or intellectual disability
- Patient cannot speak and read English sufficiently to allow for valid interpretation of a clinical assessment provided in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Mindfulness Based Cognitive Therapy to Cognitive Behavioral Therapy for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial
The present study is a randomized controlled trial comparing the efficacy and acceptability of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood or psychotic disorder onset or relapse. Young people (ages 13-24) are provided with targeted psychoeducation and learn a variety of coping skills and wellness practices for mood regulation and stress and distress management. Parents meet separately to learn the same skills and receive guidance in supporting their youth with skill development. The therapy is also augmented by a mobile phone application that supports regular symptom monitoring and skills practice.
Read the detailed description
Psychosocial interventions that improve emotional health and stability could have a dramatically favorable impact on individual suffering among adolescents and young adults at risk for severe mental illness, as well as their family members. Unfortunately, youth who are at risk for bipolar disorder or psychosis are treated with a wide variety of medications and therapies, with little evidence-based practice.
The main objective of this study is to investigate the comparative efficacy and acceptability of weekly outpatient group-based Mindfulness based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) adapted for youth at elevated risk for serious or persistent mood disorders or psychosis. Consistent with the National Institute of Mental Health's shift towards common underlying mechanisms across diagnoses ("Research Domain Criteria, or RDoc; Sanislow et al., 2010), recruitment for this study is transdiagnostic, targeting a range of youth with difficulties with mood dysregulation and stress.
All randomized control trial (RCT) participants receive one of the two active treatments. The order of treatment groups has been randomized, with participants blinded to their treatment assignment. Five to 15 young participants of similar age (teen or young adult) comprise each group. Parents receive a parallel parent-only group that informs them of the content and skills presented to their offspring.
The investigators will assess emotion dysregulation, psychiatric symptoms, overall functioning, and quality of life at baseline, immediately following the 9-week treatment, and at follow-up (3 months after therapy ends).
Clinical symptoms, cognitions, mindfulness, emotion regulation, and well-being will be measured at baseline and each follow-up assessment. Both youth and young adults will participate in a follow-up assessment immediately after the intervention. Youth participants will participate in a second follow-up assessment 12 weeks post-treatment.
The main investigative hypotheses are that both the MBCT and CBT programs will be acceptable to the young participants and parents and associated with high satisfaction ratings. Additionally, the investigators anticipate that both MBCT and CBT will be associated with comparable improvements in mood, anxiety, and psychotic symptoms and social functioning from pretreatment to final follow-up. Finally, the investigators anticipate that increases in mindfulness and reductions in negative cognitions from pretreatment to post-treatment and follow-up will be correlated with improvements in the young participants' self-reported emotional dysregulation and attention.
The study aims to add to the body of knowledge on evidence-based interventions targeting mood and stress pathways for youth at risk for chronic or serious mental health challenges.
- Being tested
- cognitive behavioral therapy, mindfulness-based cognitive therapy
- Keywords
- group therapy, psychotherapy, psychoeducation, skills training, mood disorders, prodromal psychosis, adolescents, parent group, youth
- Medical subject headings
- Mood Disorders, Prodromal Symptoms, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
9 sessions of CBT weekly treatment in group setting
mindfulness-based cognitive therapyBehavioural
9 sessions of MBCT weekly treatment in group setting
| Study group | Role | What they receive |
|---|---|---|
| Group CBT | Experimental | 9 group sessions lasting 75-90 minutes each. CBT starts with psychoeducation about emotions, their primary functions, and how our emotions can affect the way we think and behave. They next learn about behavioral strategies that can help them manage or overcome difficult emotions. Group members also complete gradual exposure exercises, which involve engaging with activities that elicit negative emotions. Finally, group members are taught cognitive skills to help them cope with difficult/stressful thoughts. Receives: Behavioral: cognitive behavioral therapy |
| Group MBCT | Experimental | 9 group sessions lasting 75-90 minutes each. The focus of sessions 1 through 4 will be learning to bring greater awareness to the present moment, on purpose, and nonjudgmentally. Appropriate responding is the focus of sessions 5 through 8. All skills are reviewed in session 9. Receives: Behavioral: mindfulness-based cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.
Semi-structured interview of youth and parent to assess recent severity of youth depression. Consensus scores are obtained for 17 items, with total scores ranging from 17 to 113 and higher scores indicating more severe depression.
Measured: 0 & 9 weeks, 6 months
Change from Baseline in Questionnaire for Measuring Health-Related Quality of Life in Children (KINDL; Ravens-Sieberer & Bullinger, 1998) scores at 9 weeks & 6 months
Self-report measure of health-related quality of life in children and adolescents. Both the parent-report scale (24-item) \& adolescent-report scale (31-item) are included, with higher total scale scores (range 0 to 100) indicating more severe problems with health-related quality of life.
Measured: 0 & 9 weeks, 6 months
Change from Baseline Children's Global Assessment Scale (C-GAS; Shaffer, 1983) scores at 9 weeks & 6 months
Assessor-rated rating of current global functioning, considering illness severity. Scores range from 1 to 100, with higher scores indicating better global functioning.
Measured: 0 & 9 weeks, 6 months
Change from Baseline Young Mania Rating Scale (YMRS; Young, Biggs, Ziegler, & Meyer, 1978) scores at 9 weeks & 6 months
Semi-structured interview of youth and parent on recent manic mood symptoms. Consensus scores are obtained from 11 items, with total scale scores ranging from 0 to 60 and higher scores indicating more severe manic symptoms.
Measured: 0 & 9 weeks, 6 months
Change from Baseline Prodromal Questionnaire - Brief (PQ-B; Loewy, Pearson, Vinogradov, Bearden, & Cannon, 2011) scores at 9 weeks & 6 months
Patient self-report measure of current severity of positive clinical high risk for psychosis symptoms. Total score is based on 21 items and represents higher level of positive symptomatology, considering associated distress and impact.
Measured: 0 & 9 weeks, 6 months
Secondary outcomes (3)
Change from Baseline Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) scores at 9 weeks & 6 months
Parental self-report measure of their own difficulties in emotion regulation. Total scores on this 36-item instrument range from 36 to 180, with higher scores indicating more severe personal difficulties with emotion regulation.
Measured: 0 & 9 weeks, 6 months
Change from Baseline Depression Anxiety Stress Scales-21 (DASS-21; Lovibond & Lovibond, 1995) scores at 9 weeks & 6 months
Parental self-report measure of their own difficulties with depression, anxiety and stress. Total scores on this 21-item instrument range from 0 to 63, with higher scores indicating more severe personal difficulties with emotion regulation.
Measured: 0 & 9 weeks, 6 months
Change from Baseline Brief COPE Inventory (Brief-COPE; Carver, 1997) scores at 9 weeks & 6 months
Youth self-report measure of their use of emotional behavioral coping strategies for stressful situations. Scores for the 28-item measure range from 28 to 112, with higher scores indicating greater use of coping strategies.
Measured: 0 & 9 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start14 Jan 2020
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David Miklowitz, PhD, Principal investigator, University of California, Los AngelesDanielle M. Denenny, PhD, Study director, University of California, Los AngelesMarc J. Weintraub, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070052
- Sponsor's protocol ID
- 14-000391
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weintraub MJ, Denenny D, Ichinose MC, Zinberg J, Morgan-Fleming G, Done M, Brown RD, Bearden CE, Miklowitz DJ. A randomized trial of telehealth mindfulness-based cognitive therapy and cognitive behavioral therapy groups for adolescents with mood or attenuated psychosis symptoms. J Consult Clin Psychol. 2023 Apr;91(4):234-241. doi: 10.1037/ccp0000782. Epub 2023 Jan 16.
PubMed 36649157
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Mindfulness Based Cognitive Therapy to Cognitive Behavioral Therapy for Youth at High Risk for Mood and Psychotic Disorders: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05070052
- Acronym / sponsor ID
- 14-000391
- Keywords
- group therapy, psychotherapy, psychoeducation, skills training, mood disorders, prodromal psychosis, adolescents, parent group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a randomized controlled trial comparing the efficacy and acceptability of CBT and MBCT group-based interventions adapted for young people at elevated risk for mood or psychotic disorder onset or relapse. Young people (ages 13-24) are provided with targeted psychoeducation and learn a variety of coping skills and wellness practices for mood regulation and stress and distress management. Parents meet separately to learn the same skills and receive guidance in supporting their youth with skill development. The therapy is also augmented by a mobile phone application that supports regular symptom monitoring and skills practice.
Detailed description
Psychosocial interventions that improve emotional health and stability could have a dramatically favorable impact on individual suffering among adolescents and young adults at risk for severe mental illness, as well as their family members. Unfortunately, youth who are at risk for bipolar disorder or psychosis are treated with a wide variety of medications and therapies, with little evidence-based practice.
The main objective of this study is to investigate the comparative efficacy and acceptability of weekly outpatient group-based Mindfulness based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) adapted for youth at elevated risk for serious or persistent mood disorders or psychosis. Consistent with the National Institute of Mental Health's shift towards common underlying mechanisms across diagnoses ("Research Domain Criteria, or RDoc; Sanislow et al., 2010), recruitment for this study is transdiagnostic, targeting a range of youth with difficulties with mood dysregulation and stress.
All randomized control trial (RCT) participants receive one of the two active treatments. The order of treatment groups has been randomized, with participants blinded to their treatment assignment. Five to 15 young participants of similar age (teen or young adult) comprise each group. Parents receive a parallel parent-only group that informs them of the content and skills presented to their offspring.
The investigators will assess emotion dysregulation, psychiatric symptoms, overall functioning, and quality of life at baseline, immediately following the 9-week treatment, and at follow-up (3 months after therapy ends).
Clinical symptoms, cognitions, mindfulness, emotion regulation, and well-being will be measured at baseline and each follow-up assessment. Both youth and young adults will participate in a follow-up assessment immediately after the intervention. Youth participants will participate in a second follow-up assessment 12 weeks post-treatment.
The main investigative hypotheses are that both the MBCT and CBT programs will be acceptable to the young participants and parents and associated with high satisfaction ratings. Additionally, the investigators anticipate that both MBCT and CBT will be associated with comparable improvements in mood, anxiety, and psychotic symptoms and social functioning from pretreatment to final follow-up. Finally, the investigators anticipate that increases in mindfulness and reductions in negative cognitions from pretreatment to post-treatment and follow-up will be correlated with improvements in the young participants' self-reported emotional dysregulation and attention.
The study aims to add to the body of knowledge on evidence-based interventions targeting mood and stress pathways for youth at risk for chronic or serious mental health challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT | Experimental | Behavioral: cognitive behavioral therapy9 group sessions lasting 75-90 minutes each. CBT starts with psychoeducation about emotions, their primary functions, and how our emotions can affect the way we think and behave. They next learn about behavioral strategies that can help them manage or overcome difficult emotions. Group members also complete gradual exposure exercises, which involve engaging with activities that elicit negative emotions. Finally, group members are taught cognitive skills to help them cope with difficult/stressful thoughts. |
| Group MBCT | Experimental | Behavioral: mindfulness-based cognitive therapy9 group sessions lasting 75-90 minutes each. The focus of sessions 1 through 4 will be learning to bring greater awareness to the present moment, on purpose, and nonjudgmentally. Appropriate responding is the focus of sessions 5 through 8. All skills are reviewed in session 9. |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient meets criteria for having experienced a (past or present) disorder marked by clinically significant mood instability, depression, and/or psychotic features (i.e., diagnosed with a mood disorder, adjustment disorder with depressed mood, or psychotic disorder) OR they are at clinical high risk for psychosis
Key exclusion criteria (4 listed)
- Patient's current severity of illness interferes with participation in a group treatment (e.g., preoccupied with internal stimuli)
- Patient has a current substance use disorder
- Patient has a pervasive developmental disorder or intellectual disability
- Patient cannot speak and read English sufficiently to allow for valid interpretation of a clinical assessment provided in English
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 |
|---|---|---|
| cognitive behavioral therapy9 sessions of CBT weekly treatment in group setting | Behavioural | Group CBT |
| mindfulness-based cognitive therapy9 sessions of MBCT weekly treatment in group setting | Behavioural | Group MBCT |
Primary outcome
Change from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months.
Time frame: 0 & 9 weeks, 6 months
Semi-structured interview of youth and parent to assess recent severity of youth depression. Consensus scores are obtained for 17 items, with total scores ranging from 17 to 113 and higher scores indicating more severe depression.
Change from Baseline in Questionnaire for Measuring Health-Related Quality of Life in Children (KINDL; Ravens-Sieberer & Bullinger, 1998) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Self-report measure of health-related quality of life in children and adolescents. Both the parent-report scale (24-item) \& adolescent-report scale (31-item) are included, with higher total scale scores (range 0 to 100) indicating more severe problems with health-related quality of life.
Change from Baseline Children's Global Assessment Scale (C-GAS; Shaffer, 1983) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Assessor-rated rating of current global functioning, considering illness severity. Scores range from 1 to 100, with higher scores indicating better global functioning.
Change from Baseline Young Mania Rating Scale (YMRS; Young, Biggs, Ziegler, & Meyer, 1978) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Semi-structured interview of youth and parent on recent manic mood symptoms. Consensus scores are obtained from 11 items, with total scale scores ranging from 0 to 60 and higher scores indicating more severe manic symptoms.
Change from Baseline Prodromal Questionnaire - Brief (PQ-B; Loewy, Pearson, Vinogradov, Bearden, & Cannon, 2011) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Patient self-report measure of current severity of positive clinical high risk for psychosis symptoms. Total score is based on 21 items and represents higher level of positive symptomatology, considering associated distress and impact.
3 secondary outcomes
Change from Baseline Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Change from Baseline Depression Anxiety Stress Scales-21 (DASS-21; Lovibond & Lovibond, 1995) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Change from Baseline Brief COPE Inventory (Brief-COPE; Carver, 1997) scores at 9 weeks & 6 months
Time frame: 0 & 9 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 36649157Weintraub MJ, Denenny D, Ichinose MC, Zinberg J, Morgan-Fleming G, Done M, Brown RD, Bearden CE, Miklowitz DJ. A randomized trial of telehealth mindfulness-based cognitive therapy and cognitive behavioral therapy groups for adolescents with mood or attenuated psychosis symptoms. J Consult Clin Psychol. 2023 Apr;91(4):234-241. doi: 10.1037/ccp0000782. Epub 2023 Jan 16.
- Individual participant dataSharing planned: No
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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.
David Miklowitz, PhD principal investigator
University of California, Los Angeles
Danielle M. Denenny, PhD study director
University of California, Los Angeles
Marc J. Weintraub study director
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy and mindfulness-based cognitive therapy in people with Mood Disorders and Prodromal Symptoms, run by University of California, Los Angeles 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 1 inclusion and 4 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 12 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Children's Depression Rating Scale-Revised (CDRS-R; Poznanski & Mokros, 1996) scores at 9 weeks & 6 months. (time frame: 0 & 9 weeks, 6 months). The study lists 5 primary outcomes in all. 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 NCT05070052, which also lists 1 linked publication.
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 12 Oct 2022.