Recurrent Major DepressionWWSNCT04106375
Neural Effects of Wellness Classes in Women With Vulnerability to Depression ("The Women's Wellness Study")
A study testing Online mindfulness based cognitive therapy intervention in people with Recurrent Major Depression, run by University of Colorado, Boulder.
Trial summary
The primary objective of the study is to examine the efficacy of mindfulness based cognitive therapy (MBCT) on the prevention of relapse in women with a history of depression. Additionally, the investigators will explore how brain activity might be affected in several brain regions as a result of MBCT. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Major Depression
- What is being tested?
- Online mindfulness based cognitive therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2016to 19 Feb 2018
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with past history of recurrent major depressive disorder
- Women who are not currently pregnant
- Meeting criteria for prior depression (at least two episodes) and showing residual symptoms of depression (PHQ-9 score of 5-12)
- Not meeting criteria for a current active depressive episode (SCID criteria)
- Having access to internet and a smartphone with data plan
- Receiving no antidepressant/anxiolytic medication or under a stable regime of antidepressants/anxiolytics
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- Healthy control women
- Women that are not currently pregnant
- Do not meet criteria for prior or current depression
- Have access to internet and a smartphone with data plan
Who cannot join
- Current diagnoses of: psychosis, bipolar disorder/maniac episodes, OCD, persistent antisocial behavior, severe developmental delay, or persistent self-injury needing clinical management or therapy, organic brain injury, substance misuse.
- Past diagnoses of psychosis, bipolar disorder/mania episodes or OCD.
- Use of marijuana equal or more than 4 days per week.
- Additional exclusion criteria related to Magnetic Resonance Imaging safety requirements:
- We will exclude participants who have metal or electrical equipment including:
- Non-removable metal piercing
Show all 18Show fewer
- Tattoos on head or neck, an older tattoo with metal-containing inks, and/or permanent makeup (eyeliner).
- An implanted (internal) defibrillator or pacemaker
- Cochlear (ear) implant
- Some type of clips used on brain aneurysms
- An intrauterine device (IUD) that is not compatible with the MRI scanner
- An implanted infusion pump device like an insulin pump
- Implanted nerve stimulators
- Magnetic dental appliances or fillings
- Metal plates, screws, staples, joint replacement, and prosthetics.
- Additional exclusion criteria for all participants include the following:
- Clear claustrophobic symptoms.
- Abnormal capability of performing the experimental tasks as they are designed and implemented (e.g., unable to read, unable to cooperate during fMRI examination, showing visual processing impairments that cannot be corrected using lenses or any significant impairments in the processing of auditory stimulation).
About this study
Official title: Brain Mechanisms of Mindfulness Based Cognitive Therapy in Women at High Risk for Depressive Relapse ("The Women's Wellness Study")
The primary objective of the study is to examine the efficacy of mindfulness based cognitive therapy (MBCT) on the prevention of relapse in women with a history of depression. Additionally, the investigators will explore how brain activity might be affected in several brain regions as a result of MBCT. This study consists of two groups, a patient group consisting of women with a history of depression and a control group consisting of healthy women. All participants within the patient group will receive an 8-week MBCT intervention program and will continue their normal medication treatment. Participants will undergo, both pre and post intervention, various behavioral and neuroimaging tasks to assess intervention effects of well-established psychological measurements related to cognitive and emotional function.
Read the detailed description
Overall, this study aims to characterize the neural and psychological effects of an eight-week mindfulness based cognitive therapy (MBCT) intervention (online group class) in preventing depressive relapse in women with past history of major depression when exposed to different forms of self-relevant and context-specific emotional challenge. The investigators also aim to establish psychological and neural mechanisms contributing to depressive symptoms prior to intervention. A key objective of the study is to assess baseline markers of depressive symptoms and possible change resulting from the MBCT intervention from interdisciplinary perspectives, including the psychological perspective (i.e. measured with computer-based tasks, self-report ratings, questionnaires, etc.) and the neural perspective (neural activity measured with functional MRI).
In addition, a critical factor the investigators will be observing is the shift from more 'narrative' to 'experiential' forms of self-related awareness as a function of MBCT. Narrative self-focus refers to a concept of self that is extended in time, including past memories and intentions for the future, together with abstract self-representations in relation to socio-emotional values. In contrast, the "experiential self-focus" refers to a more immediate self-experience and is associated with greater awareness of external stimuli and internal somatic-visceral bodily states. MBSR has been shown to increase brain activity in regions relevant for conferring "experiential" self-focus (insula-opercula, dorsal anterior cingulate/supplementary motor area), while decreasing responses in rostral-medial, lateral frontal and hippocampal regions that support the "narrative" mode of self-focus. Such changes in brain activity are associated with increased well-being. Brain regions to be examined include: 1) insula-opercula and dorsal anterior cingulate brain regions responsible for mediating 'narrative' self-focus thinking styles; 2) rostral-medial and lateral frontal, and hippocampal brain regions responsible for mediating 'experiential' self-focus thinking styles; and 3) default mode and insular-paralimbic networks thought to be involved in the generation and maintenance of depressive episodes.
Behavioral Tasks
- Breath Count Task - an objective behavioral measure of mindfulness; Dot-Probe Task - a measure of negative emotion attentional bias
- Autobiographical Memory Interview - a means to quantify the nature of participants' autobiographical memory recall in an ecologically-valid manner
- Free-Association Semantic Task - a measure of associative processing
- Emotional Movies - a measure of emotional reactivity
- N-Back Task - a measure of working memory.
Neuroimaging Tasks
- Rest Task - a means to examine brain activity and thought content during an unconstrained task
- 'Narrative' vs 'Experiential' Task during Autobiographical Memory Recall vs. n-back - a means to examine brain activity during 'narrative' vs 'experiential' forms of self-focus during autobiographical memory recall, vs. a demanding working memory task.
- Self-Syllable Judgment Task - a means to examine brain activity during self-judgment vs non-self-judgment tasks.
Thought Sampling Participants will undergo an experience sampling paradigm in which daily thought surveys will be administered multiple times per day over the course of 7-10 days. These thought sampling surveys are designed to estimate several factors characterizing the occurrence of spontaneous thoughts in real-world settings as well as the nature and content of individuals' thoughts in real-world settings.
- Conditions
- Recurrent Major Depression
- Being tested
- Online mindfulness based cognitive therapy intervention
- Keywords
- major depression, Mindfulness based cognitive therapy, MBCT, fMRI, recurrent depression, brain
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness based cognitive therapy interventionBehavioural
Also called online MBCT, Mindful mood balance (MMB)
MBCT is based on Mindfulness-Based Stress Reduction (MBSR), combining principles of cognitive therapy (CT) with those of mindfulness meditation to prevent depression relapse. Both MBSR and MBCT use contemplative practices, including sitting meditation, body scan and walking meditation, as core methods to teach awareness of negative thoughts and emotions with the aim of disengaging from pervasive patterns of ruminative self-centered mentation. Participants will be given an initial orientation session and then complete an online 8-week MBCT program. Each week participants will take part in one 2-hour online group session and will complete homework assignments anticipated to take 15-30 minutes per day to complete. Additionally, weekly phone coaching will be offered based on the modified tele-coach manual developed by Mohr and colleagues (Duffecy et al. 2010).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Women with a history of depression and no other mental health disorders undergoing Mindfulness Based Cognitive Therapy. Receives: Behavioral: Online mindfulness based cognitive therapy intervention |
| Control | No intervention | Healthy women with no prior history of depression or other mental health disorders as a control group for time-repetition effects on brain activity and task performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of mood episodes and post treatment relapse rate
Assessed via clinical interview
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Depression symptoms
Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Rumination
Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Cognitive Decentering
Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, \& Williams, 2007)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Self-Compassion
Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Mindfulness
Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer \& Toney, 2006)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Autobiographical Memory
Assessed via the Autobiographical Memory Test (Williams \& Broadbent, 1986)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Self concept
Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Brain activity during autobiographical memory recall
Measured using task-based fMRI bold sequence
Measured: Up to 15 weeks
Brain activity in the absence of a task
Measured using fMRI resting-state bold sequence
Measured: Up to 15 weeks
Brain activity during processing of self-referential traits
Measured using task-based fMRI bold sequence
Measured: Up to 15 weeks
Everyday thinking patterns
Measured with experience sampling in daily life, questions developed for our study
Measured: Up to 15 weeks
Secondary outcomes (12)
Mindfulness
Assessed using the previously validated breath counting task (Levinson et al., 2014)
Measured: Up to 15 weeks
Lexical Associations
Assessed using the Thought fluency task (Andrews-Hanna et al., in prep.)
Measured: Up to 15 weeks
Worry
Worry score using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, \& Borkovec, 1990).
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Fatigue
Assessed using the Multidimensional Fatigue Inventory (Smets et al. 1995).
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Physical pain
Assessed using the Brief Pain Inventory-short form (Cleeland and Ryan, 1994).
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Expectations about treatment outcome
Score in the Credibility/Expectancy Questionnaire (CEQ, Devilly, G. J., \& Borkovec, T. D. 2000)
Measured: Pre-intervention
Client satisfaction about treatment outcome
Assessed using the Client Satisfaction Questionnaire (CSQ, Attkisson \& Greenfield, 2009).
Measured: Up to 15 weeks
Positive and negative emotion
Assessed by measuring responses while watching emotional movies (based on Gruber et al, 2008)
Measured: Up to 15 weeks
Positive and negative affect
Assessed using the Positive and Negative Affect Scale (PANAS; Watson \& Clark, 1994)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Emotion-induced attentional bias
Assessed using the dot-brobe task (Kruijt et al., 2016)
Measured: Up to 15 weeks
Mind wandering
Score on the Imaginal Process Inventory (IPI, Singer et al., 1963)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Well-being
Assessed via the Ryff Scales of Psychological Well-Being (RYFF; Ryff, 1989; Ryff \& Keyes, 1995)
Measured: Throughout study (pre-intervention to 6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start5 Mar 2016
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Major DepressionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group of 25 currently remitted recurrent major depression patients undergoing mindfulness based cognitive therapy for 8 weeks and one group of 25 matched healthy controls to control for time-repetition effects on brain activity and task performance
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts, University of Arizona, University of Toronto, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Marina Lopez Sola, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106375
- Sponsor's protocol ID
- 13-0257
- Acronym
- WWS
- Status last verified
- Sep 2019
- First submitted
- 9 Jul 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Mindfulness Based Cognitive Therapy in Women at High Risk for Depressive Relapse ("The Women's Wellness Study")
- ClinicalTrials.gov ID
- NCT04106375
- Acronym / sponsor ID
- WWS / 13-0257
- Conditions
- Recurrent Major Depression
- Keywords
- major depression, Mindfulness based cognitive therapy, MBCT, fMRI, recurrent depression, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts, University of Arizona, University of Toronto, Children's Hospital Medical Center, Cincinnati
- Study start
- 5 Mar 2016 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 27 Sep 2019 (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 primary objective of the study is to examine the efficacy of mindfulness based cognitive therapy (MBCT) on the prevention of relapse in women with a history of depression. Additionally, the investigators will explore how brain activity might be affected in several brain regions as a result of MBCT. This study consists of two groups, a patient group consisting of women with a history of depression and a control group consisting of healthy women. All participants within the patient group will receive an 8-week MBCT intervention program and will continue their normal medication treatment. Participants will undergo, both pre and post intervention, various behavioral and neuroimaging tasks to assess intervention effects of well-established psychological measurements related to cognitive and emotional function.
Detailed description
Overall, this study aims to characterize the neural and psychological effects of an eight-week mindfulness based cognitive therapy (MBCT) intervention (online group class) in preventing depressive relapse in women with past history of major depression when exposed to different forms of self-relevant and context-specific emotional challenge. The investigators also aim to establish psychological and neural mechanisms contributing to depressive symptoms prior to intervention. A key objective of the study is to assess baseline markers of depressive symptoms and possible change resulting from the MBCT intervention from interdisciplinary perspectives, including the psychological perspective (i.e. measured with computer-based tasks, self-report ratings, questionnaires, etc.) and the neural perspective (neural activity measured with functional MRI).
In addition, a critical factor the investigators will be observing is the shift from more 'narrative' to 'experiential' forms of self-related awareness as a function of MBCT. Narrative self-focus refers to a concept of self that is extended in time, including past memories and intentions for the future, together with abstract self-representations in relation to socio-emotional values. In contrast, the "experiential self-focus" refers to a more immediate self-experience and is associated with greater awareness of external stimuli and internal somatic-visceral bodily states. MBSR has been shown to increase brain activity in regions relevant for conferring "experiential" self-focus (insula-opercula, dorsal anterior cingulate/supplementary motor area), while decreasing responses in rostral-medial, lateral frontal and hippocampal regions that support the "narrative" mode of self-focus. Such changes in brain activity are associated with increased well-being. Brain regions to be examined include: 1) insula-opercula and dorsal anterior cingulate brain regions responsible for mediating 'narrative' self-focus thinking styles; 2) rostral-medial and lateral frontal, and hippocampal brain regions responsible for mediating 'experiential' self-focus thinking styles; and 3) default mode and insular-paralimbic networks thought to be involved in the generation and maintenance of depressive episodes.
Behavioral Tasks
- Breath Count Task - an objective behavioral measure of mindfulness; Dot-Probe Task - a measure of negative emotion attentional bias
- Autobiographical Memory Interview - a means to quantify the nature of participants' autobiographical memory recall in an ecologically-valid manner
- Free-Association Semantic Task - a measure of associative processing
- Emotional Movies - a measure of emotional reactivity
- N-Back Task - a measure of working memory.
Neuroimaging Tasks
- Rest Task - a means to examine brain activity and thought content during an unconstrained task
- 'Narrative' vs 'Experiential' Task during Autobiographical Memory Recall vs. n-back - a means to examine brain activity during 'narrative' vs 'experiential' forms of self-focus during autobiographical memory recall, vs. a demanding working memory task.
- Self-Syllable Judgment Task - a means to examine brain activity during self-judgment vs non-self-judgment tasks.
Thought Sampling Participants will undergo an experience sampling paradigm in which daily thought surveys will be administered multiple times per day over the course of 7-10 days. These thought sampling surveys are designed to estimate several factors characterizing the occurrence of spontaneous thoughts in real-world settings as well as the nature and content of individuals' thoughts in real-world settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group of 25 currently remitted recurrent major depression patients undergoing mindfulness based cognitive therapy for 8 weeks and one group of 25 matched healthy controls to control for time-repetition effects on brain activity and task performance
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Online mindfulness based cognitive therapy interventionWomen with a history of depression and no other mental health disorders undergoing Mindfulness Based Cognitive Therapy. |
| Control | No intervention | –Healthy women with no prior history of depression or other mental health disorders as a control group for time-repetition effects on brain activity and task performance |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women with past history of recurrent major depressive disorder
- Healthy control women
Key exclusion criteria (18 listed)
- Current diagnoses of: psychosis, bipolar disorder/maniac episodes, OCD, persistent antisocial behavior, severe developmental delay, or persistent self-injury needing clinical management or therapy, organic brain injury, substance misuse.
- Past diagnoses of psychosis, bipolar disorder/mania episodes or OCD.
- Use of marijuana equal or more than 4 days per week.
- Non-removable metal piercing
- Tattoos on head or neck, an older tattoo with metal-containing inks, and/or permanent makeup (eyeliner).
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 |
|---|---|---|
| Online mindfulness based cognitive therapy interventionAlso: online MBCT, Mindful mood balance (MMB)MBCT is based on Mindfulness-Based Stress Reduction (MBSR), combining principles of cognitive therapy (CT) with those of mindfulness meditation to prevent depression relapse. Both MBSR and MBCT use contemplative practices, including sitting meditation, body scan and walking meditation, as core methods to teach awareness of negative thoughts and emotions with the aim of disengaging from pervasive patterns of ruminative self-centered mentation. Participants will be given an initial orientation session and then complete an online 8-week MBCT program. Each week participants will take part in one 2-hour online group session and will complete homework assignments anticipated to take 15-30 minutes per day to complete. Additionally, weekly phone coaching will be offered based on the modified tele-coach manual developed by Mohr and colleagues (Duffecy et al. 2010). | Behavioural | Intervention Group |
Primary outcome
Occurrence of mood episodes and post treatment relapse rate
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Assessed via clinical interview
Depression symptoms
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Assessed via Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001)
Rumination
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Rumination score measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema 1987;1999).
Cognitive Decentering
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Score in the Experiences Questionnaire (Fresco, Moore, Dulmen, Segal, Ma, Teasdale, \& Williams, 2007)
Self-Compassion
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Self-compassion scores measured using the Self-Compassion Scale (SCS: Neff, 2003).
Mindfulness
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Score on the Five-factor Mindfulness Scale (FFMQ; Baer, Smith, Hopkins, Krietemeyer \& Toney, 2006)
Autobiographical Memory
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Assessed via the Autobiographical Memory Test (Williams \& Broadbent, 1986)
Self concept
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Assessed via the Twenty Statements Test (Kuhn and McPartland, 1954)
Brain activity during autobiographical memory recall
Time frame: Up to 15 weeks
Measured using task-based fMRI bold sequence
Brain activity in the absence of a task
Time frame: Up to 15 weeks
Measured using fMRI resting-state bold sequence
Brain activity during processing of self-referential traits
Time frame: Up to 15 weeks
Measured using task-based fMRI bold sequence
Everyday thinking patterns
Time frame: Up to 15 weeks
Measured with experience sampling in daily life, questions developed for our study
12 secondary outcomes
Mindfulness
Time frame: Up to 15 weeks
Lexical Associations
Time frame: Up to 15 weeks
Worry
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Fatigue
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Physical pain
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Expectations about treatment outcome
Time frame: Pre-intervention
Client satisfaction about treatment outcome
Time frame: Up to 15 weeks
Positive and negative emotion
Time frame: Up to 15 weeks
Positive and negative affect
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Emotion-induced attentional bias
Time frame: Up to 15 weeks
Mind wandering
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
Well-being
Time frame: Throughout study (pre-intervention to 6 months post-intervention)
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 27 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness based cognitive therapy intervention in people with Recurrent Major Depression, run by University of Colorado, Boulder.
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 10 inclusion and 18 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Occurrence of mood episodes and post treatment relapse rate (time frame: Throughout study (pre-intervention to 6 months post-intervention)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.