Major Depressive DisorderNCT05108701
Individual MBCT vs. CBT in Major Depression: A Pilot Study.
A study testing Individual Psychotherapy in people with Major Depressive Disorder, run by The Royal Ottawa Mental Health Centre.
Trial summary
Background: Depression is a highly recurrent disorder, which often requires lifelong treatment. Psychotherapy has an important role in the treatment of depression, both in the treatment of the acute phase and in prevention of relapses. Mindfulness-based therapies have become popular in the last decade. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Individual Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 15 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: a) Diagnosis of MDD, current episode mild to moderate or in partial remission, according to the Diagnostic and Statistical Manual of Mental Disorders - DSM-IV criteria; b) Hamilton rating scale for Depression (HAMD-17), total score between 8 and 18, included; c) age between 18 and 65 years, d) able to comply with the study protocol, e.g. able to attend weekly sessions; and e) English speaking and able to provide informed consent.
Exclusion Criteria: a) a current diagnosis of bipolar disorder, substance use disorder, schizophrenia or primary personality disorder; b) a trial of electroconvulsive therapy (ECT) in the past 6 months; c) depression secondary to a concurrent medical disorder; d) current practice of meditation more than once per week or yoga more than twice per week; and e) treated with MBCT or CBT in the previous year.
About this study
Official title: Individual Mindfulness-Based Cognitive Therapy vs. Cognitive Behavior Therapy and Treatment As Usual as Treatment for Major Depressive Disorder: A Pilot Study.
Background: Depression is a highly recurrent disorder, which often requires lifelong treatment. Psychotherapy has an important role in the treatment of depression, both in the treatment of the acute phase and in prevention of relapses. Mindfulness-based therapies have become popular in the last decade. Mindfulness-based Cognitive Therapy (MBCT) is an established treatment for relapse prevention in Major Depressive Disorder (MDD) and there is preliminary evidence of its efficacy in treating acute symptoms. Several studies have highlighted the benefits of MBCT in reducing the severity of depressive symptoms in patients diagnosed with a current Major Depressive Episode, as indicated by some meta-analyses showing that MBCT is more effective than treatment as usual in decreasing depressive symptoms and equivalent to active treatments. However, the results at follow-up were less conclusive, due to the limited number of studies and moderate-to-large heterogeneity within the subgroups.
A number of studies have examined the effects of MBCT on a larger spectrum of factors that can affect the severity of depression. In patients with MDD, MBCT was more effective than treatment as usual in decreasing rumination, worry, negative affect and dysfunctional attitudes, increasing mindfulness skills and positive affect and improving sleep and quality of life. However, data comparing the specific effect of MBCT with other active treatments (for example Cognitive Behavioural Therapy, CBT) are lacking.
Read more
Most trials exploring the efficacy of MBCT have been conducted with group MBCT, but there is less evidence about the use of individual MBCT (I-MBCT). Individual MBCT may have some advantages, compared with group therapy, such as better attendance and higher efficacy in major depression, when compared with group therapy. Furthermore, the individual format can often be better tailored to a specific patient, with a slower progression and a longer number of sessions, if needed.
Objective: The primary objective of this pilot trial was to test the feasibility of a larger randomized trial examining the changes in depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts during I-MBCT and cognitive behavioural therapy (CBT). Further objectives were: (a) replicating studies evaluating the efficacy of I-MBCT to improve depression, in particularly in patients diagnosed with a major depressive disorder; (b) assessing the persistence of benefits of I-MBCT after the end of treatment; (c) comparing the effects of I-MBCT with CBT, not only on depressive symptoms, but also on factors which are specifically targeted by MBCT, such as rumination and mindfulness; explore possible predictors of outcome of MBCT.
Hypotheses: We make the following hypotheses: a) a larger trial comparing I-MBCT with CBT examining the changes of depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts is feasible, with recruitment rates and drop-off rates consistent with those usually observed among participants with current major depression; b) the levels of depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts will decrease during I-MBCT, while the levels of mindfulness and behavioral activation will increase, with effect sizes similar to those observed in CBT; c) the changes in depressive and anxiety symptoms, rumination, emotion dysregulation, negative automatic thoughts, mindfulness and behavioral activation will be maintained at follow-up; d) the changes in mindfulness and rumination dimensions are expected to be larger during MBCT than CBT; these analyses will be exploratory, given the state of knowledge; d) we will explore the role of predictors of clinical variables, such as earlier age at onset of the mood disorder; longer and more severe current episode; presence of current comorbidity with anxiety disorders, initial levels of anxiety, behavioral activation, emotion dysregulation and of the history of severe childhood maltreatment in predicting the outcome to MBCT and CBT.
Read the detailed description
The trial is a parallel, two-arm, randomised pilot trial (Ottawa, Ontario, Canada). Participants will be recruited from the Mood and Anxiety Program of the Royal Ottawa Mental Health Centre, which is a specialized tertiary care centre, and from two psychiatrists working in community.
Procedure Participants will be referred to the study by the treating psychiatrist, then screened in a telephone interview by the research coordinator; the eligibility criteria will be finally assessed by a psychiatrist involved in the study and by the research coordinator. The psychiatrist will administer the Structured Clinical Interview (SCID) for DSM-IV-TR (First et al. 2002) and collect the information related to clinical variables: previous hospitalizations, history of suicide attempts, comorbidity with a current anxiety disorder, age at onset of the mood disorder, number of previous major depressive episodes, duration of the current episode, severity of the current depressive episode, use of alcohol or street drugs, family history of affective disorders, and number of chronic medical conditions. The research coordinator will assess the severity of depression using the HAMD-17. If the criteria of eligibility to the study were satisfied, participants will be asked to sign an informed written consent. Individuals meeting study criteria will be randomly assigned by computer-generated numbers to treatment with either I-MBCT or CBT (1:1). Participants included in the trial will be followed by the referring clinician. Concurrent use of psychotropics will be allowed. Concomitant treatment with any form of structured "bona fide" psychotherapy is not permitted during the study.
Participants randomized to I-MBCT receive 12 weekly 60- minute sessions of I-MBCT according to the protocol of Segal et al. (2002), integrated with the "theme, rationale, intention and practice" skills (TRIP) protocol (Woods et al. 2016, 2019). The original MBCT protocol, created for eight group sessions lasting two hours, is adapted to twelve individual sessions.
Participants randomized to CBT receive 12 weekly 60-minute individual sessions of standard CBT strategies following Beck et al. (1979). Participants receive a copy of Greenberger and Padesky's Mind over Mood (The Guilford Press, 1995) for use during the intervention.
Data Analyses The statistical analysis will be performed on the overall sample of patients who will start the treatment. As this was a feasibility study, a formal sample size calculation was not required. We applied the "rule of thumb" recommended by Julious (2005), suggesting a minimum of 12 participants per treatment arm, which optimizes the gain in precision around the mean. Pre-treatment demographic and clinical characteristics will be compared between I-MBCT and CBT treatment using univariate analyses (t-test for continuous variables and Fisher test for categorical variables).
The primary outcome will be the HAM-D. The changes in depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts during MBCT and at follow-up will be tested through linear mixed-effects models (LMM, SPSS Mixed procedure). Interaction between time and treatment will be use to compare the changes during MBCT and CBT. Multiple regression analyses will be used to test the value of clinical variables in predicting the changes in severity of depressive symptoms during psychotherapy, adjusting for age, gender and baseline depressive severity .
To evaluate the strength of the changes in outcome variables (depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts) during I-MBCT and CBT, within-group effect sizes of the change pre- and post-treatment using Cohen's delta for repeated measures will be used.
- Conditions
- Major Depressive Disorder
- Being tested
- Individual Psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual PsychotherapyBehavioural
Psychotherapy using meditation, yoga, through being in the present moment a non judgmental way and open minded
| Study group | Role | What they receive |
|---|---|---|
| I-MBCT | Experimental | Participants randomized to I-MBCT (Mindfulness-Based Cognitive Therapy) receive 12 weekly 60- minute sessions of I-MBCT according to the protocol of Segal et al. (2002), integrated with the "theme, rationale, intention and practice" skills (TRIP) protocol (Woods et al. 2016, 2019). The original MBCT protocol, created for eight group sessions lasting two hours, is adapted to twelve individual sessions. Receives: Behavioral: Individual Psychotherapy |
| CBT | Active comparator | Participants randomized to Individual Cognitive Behavioural Therapy (CBT) receive 12 weekly 60-minute individual sessions of standard CBT strategies following Beck et al. (1979). Participants receive a copy of Greenberger and Padesky's Mind over Mood (The Guilford Press, 1995) for use during the intervention. Receives: Behavioral: Individual Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton for Depression - 17 items
clinician-rated scale measure of depression severity
Measured: 10 minutes
Secondary outcomes (7)
Beck Depression Inventory - Depression
self-rated measure of depression severity
Measured: 3 minutes
Five Facet Mindfulness Questionnaire
self-rated measure of mindfulness
Measured: 3 minutes
Reflection Rumination Questionnaire - Rumination subscale (RRQ)
self-rated measure of rumination
Measured: 3 minutes
Difficulties in Emotion Regulation Scale
self-rated measure of emotion regulation
Measured: 3 minutes
Automatic Thoughts Questionnaire
self-rated measure of negative automatic thoughts
Measured: 3 minutes
Beck Anxiety Inventory
self-rated measure of anxiety
Measured: 3 minutes
Behavioral Activation for Depression Scale
self-rated measure of behavioural activation
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start2 Nov 2015
- Primary completion15 Jan 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, two-arm, randomised pilot trial comparing Individual MBCT with Individual CBT
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108701
- Sponsor's protocol ID
- G6302357
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tovote KA, Fleer J, Snippe E, Peeters AC, Emmelkamp PM, Sanderman R, Links TP, Schroevers MJ. Individual mindfulness-based cognitive therapy and cognitive behavior therapy for treating depressive symptoms in patients with diabetes: results of a randomized controlled trial. Diabetes Care. 2014 Sep;37(9):2427-34. doi: 10.2337/dc13-2918. Epub 2014 Jun 4.
PubMed 24898301Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.
PubMed 20846726Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Kearney DJ, Simpson TL. Mindfulness-based cognitive therapy for the treatment of current depressive symptoms: a meta-analysis. Cogn Behav Ther. 2019 Nov;48(6):445-462. doi: 10.1080/16506073.2018.1556330. Epub 2019 Feb 8.
PubMed 30732534
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Mindfulness-Based Cognitive Therapy vs. Cognitive Behavior Therapy and Treatment As Usual as Treatment for Major Depressive Disorder: A Pilot Study.
- ClinicalTrials.gov ID
- NCT05108701
- Acronym / sponsor ID
- G6302357
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 5 Nov 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.
Background: Depression is a highly recurrent disorder, which often requires lifelong treatment. Psychotherapy has an important role in the treatment of depression, both in the treatment of the acute phase and in prevention of relapses. Mindfulness-based therapies have become popular in the last decade. Mindfulness-based Cognitive Therapy (MBCT) is an established treatment for relapse prevention in Major Depressive Disorder (MDD) and there is preliminary evidence of its efficacy in treating acute symptoms. Several studies have highlighted the benefits of MBCT in reducing the severity of depressive symptoms in patients diagnosed with a current Major Depressive Episode, as indicated by some meta-analyses showing that MBCT is more effective than treatment as usual in decreasing depressive symptoms and equivalent to active treatments. However, the results at follow-up were less conclusive, due to the limited number of studies and moderate-to-large heterogeneity within the subgroups.
A number of studies have examined the effects of MBCT on a larger spectrum of factors that can affect the severity of depression. In patients with MDD, MBCT was more effective than treatment as usual in decreasing rumination, worry, negative affect and dysfunctional attitudes, increasing mindfulness skills and positive affect and improving sleep and quality of life. However, data comparing the specific effect of MBCT with other active treatments (for example Cognitive Behavioural Therapy, CBT) are lacking.
Most trials exploring the efficacy of MBCT have been conducted with group MBCT, but there is less evidence about the use of individual MBCT (I-MBCT). Individual MBCT may have some advantages, compared with group therapy, such as better attendance and higher efficacy in major depression, when compared with group therapy. Furthermore, the individual format can often be better tailored to a specific patient, with a slower progression and a longer number of sessions, if needed.
Objective: The primary objective of this pilot trial was to test the feasibility of a larger randomized trial examining the changes in depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts during I-MBCT and cognitive behavioural therapy (CBT). Further objectives were: (a) replicating studies evaluating the efficacy of I-MBCT to improve depression, in particularly in patients diagnosed with a major depressive disorder; (b) assessing the persistence of benefits of I-MBCT after the end of treatment; (c) comparing the effects of I-MBCT with CBT, not only on depressive symptoms, but also on factors which are specifically targeted by MBCT, such as rumination and mindfulness; explore possible predictors of outcome of MBCT.
Hypotheses: We make the following hypotheses: a) a larger trial comparing I-MBCT with CBT examining the changes of depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts is feasible, with recruitment rates and drop-off rates consistent with those usually observed among participants with current major depression; b) the levels of depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts will decrease during I-MBCT, while the levels of mindfulness and behavioral activation will increase, with effect sizes similar to those observed in CBT; c) the changes in depressive and anxiety symptoms, rumination, emotion dysregulation, negative automatic thoughts, mindfulness and behavioral activation will be maintained at follow-up; d) the changes in mindfulness and rumination dimensions are expected to be larger during MBCT than CBT; these analyses will be exploratory, given the state of knowledge; d) we will explore the role of predictors of clinical variables, such as earlier age at onset of the mood disorder; longer and more severe current episode; presence of current comorbidity with anxiety disorders, initial levels of anxiety, behavioral activation, emotion dysregulation and of the history of severe childhood maltreatment in predicting the outcome to MBCT and CBT.
Detailed description
The trial is a parallel, two-arm, randomised pilot trial (Ottawa, Ontario, Canada). Participants will be recruited from the Mood and Anxiety Program of the Royal Ottawa Mental Health Centre, which is a specialized tertiary care centre, and from two psychiatrists working in community.
Procedure Participants will be referred to the study by the treating psychiatrist, then screened in a telephone interview by the research coordinator; the eligibility criteria will be finally assessed by a psychiatrist involved in the study and by the research coordinator. The psychiatrist will administer the Structured Clinical Interview (SCID) for DSM-IV-TR (First et al. 2002) and collect the information related to clinical variables: previous hospitalizations, history of suicide attempts, comorbidity with a current anxiety disorder, age at onset of the mood disorder, number of previous major depressive episodes, duration of the current episode, severity of the current depressive episode, use of alcohol or street drugs, family history of affective disorders, and number of chronic medical conditions. The research coordinator will assess the severity of depression using the HAMD-17. If the criteria of eligibility to the study were satisfied, participants will be asked to sign an informed written consent. Individuals meeting study criteria will be randomly assigned by computer-generated numbers to treatment with either I-MBCT or CBT (1:1). Participants included in the trial will be followed by the referring clinician. Concurrent use of psychotropics will be allowed. Concomitant treatment with any form of structured "bona fide" psychotherapy is not permitted during the study.
Participants randomized to I-MBCT receive 12 weekly 60- minute sessions of I-MBCT according to the protocol of Segal et al. (2002), integrated with the "theme, rationale, intention and practice" skills (TRIP) protocol (Woods et al. 2016, 2019). The original MBCT protocol, created for eight group sessions lasting two hours, is adapted to twelve individual sessions.
Participants randomized to CBT receive 12 weekly 60-minute individual sessions of standard CBT strategies following Beck et al. (1979). Participants receive a copy of Greenberger and Padesky's Mind over Mood (The Guilford Press, 1995) for use during the intervention.
Data Analyses The statistical analysis will be performed on the overall sample of patients who will start the treatment. As this was a feasibility study, a formal sample size calculation was not required. We applied the "rule of thumb" recommended by Julious (2005), suggesting a minimum of 12 participants per treatment arm, which optimizes the gain in precision around the mean. Pre-treatment demographic and clinical characteristics will be compared between I-MBCT and CBT treatment using univariate analyses (t-test for continuous variables and Fisher test for categorical variables).
The primary outcome will be the HAM-D. The changes in depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts during MBCT and at follow-up will be tested through linear mixed-effects models (LMM, SPSS Mixed procedure). Interaction between time and treatment will be use to compare the changes during MBCT and CBT. Multiple regression analyses will be used to test the value of clinical variables in predicting the changes in severity of depressive symptoms during psychotherapy, adjusting for age, gender and baseline depressive severity .
To evaluate the strength of the changes in outcome variables (depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts) during I-MBCT and CBT, within-group effect sizes of the change pre- and post-treatment using Cohen's delta for repeated measures will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, two-arm, randomised pilot trial comparing Individual MBCT with Individual CBT
| Arm | Type | Receives |
|---|---|---|
| I-MBCT | Experimental | Behavioral: Individual PsychotherapyParticipants randomized to I-MBCT (Mindfulness-Based Cognitive Therapy) receive 12 weekly 60- minute sessions of I-MBCT according to the protocol of Segal et al. (2002), integrated with the "theme, rationale, intention and practice" skills (TRIP) protocol (Woods et al. 2016, 2019). The original MBCT protocol, created for eight group sessions lasting two hours, is adapted to twelve individual sessions. |
| CBT | Active comparator | Behavioral: Individual PsychotherapyParticipants randomized to Individual Cognitive Behavioural Therapy (CBT) receive 12 weekly 60-minute individual sessions of standard CBT strategies following Beck et al. (1979). Participants receive a copy of Greenberger and Padesky's Mind over Mood (The Guilford Press, 1995) for use during the intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Individual PsychotherapyPsychotherapy using meditation, yoga, through being in the present moment a non judgmental way and open minded | Behavioural | CBT, I-MBCT |
Primary outcome
Hamilton for Depression - 17 items
Time frame: 10 minutes
clinician-rated scale measure of depression severity
7 secondary outcomes
Beck Depression Inventory - Depression
Time frame: 3 minutes
Five Facet Mindfulness Questionnaire
Time frame: 3 minutes
Reflection Rumination Questionnaire - Rumination subscale (RRQ)
Time frame: 3 minutes
Difficulties in Emotion Regulation Scale
Time frame: 3 minutes
Automatic Thoughts Questionnaire
Time frame: 3 minutes
Beck Anxiety Inventory
Time frame: 3 minutes
Behavioral Activation for Depression Scale
Time frame: 3 minutes
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 5 Nov 2021.
- Background: PubMed 24898301Tovote KA, Fleer J, Snippe E, Peeters AC, Emmelkamp PM, Sanderman R, Links TP, Schroevers MJ. Individual mindfulness-based cognitive therapy and cognitive behavior therapy for treating depressive symptoms in patients with diabetes: results of a randomized controlled trial. Diabetes Care. 2014 Sep;37(9):2427-34. doi: 10.2337/dc13-2918. Epub 2014 Jun 4.
- Background: PubMed 20846726Chiesa A, Serretti A. Mindfulness based cognitive therapy for psychiatric disorders: a systematic review and meta-analysis. Psychiatry Res. 2011 May 30;187(3):441-53. doi: 10.1016/j.psychres.2010.08.011. Epub 2010 Sep 16.
- Background: PubMed 30732534Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Kearney DJ, Simpson TL. Mindfulness-based cognitive therapy for the treatment of current depressive symptoms: a meta-analysis. Cogn Behav Ther. 2019 Nov;48(6):445-462. doi: 10.1080/16506073.2018.1556330. Epub 2019 Feb 8.
- 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 Individual Psychotherapy in people with Major Depressive Disorder, run by The Royal Ottawa Mental Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Nov 2021. 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?
Hamilton for Depression - 17 items (time frame: 10 minutes). 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 NCT05108701, which also lists 3 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 5 Nov 2021.