Testing Acceptance and Commitment Therapy with Ketamine for depression - major depressive disorder
Official title: ACT_for Alcohol Use Disorder and Depression
Acceptance and Commitment Therapy in Patients With Alcohol Use Disorder and Comorbid Treatment-Resistant Depression Who Are Undergoing Ketamine Intervention: A Feasibility Study
Interventions
Acceptance and Commitment Therapy
The ACT intervention consists of eight weekly 50 minute sessions, delivered in person when possible, with virtual options available. ACT targets psychological flexibility by addressing fusion, evaluation, avoidance, and reason giving through six core processes: acceptance, values, committed action, present moment awareness, cognitive defusion, and self as context. Sessions combine didactic content and experiential exercises following a standardized manual, with therapists trained in ACT. Participants receive a workbook to support practice. Each session begins with a brief mindfulness exercise that evolves across weeks, starting with grounding and simple emotional labeling, then progressing to neutral sensory descriptions and openness to challenging sensations.
Ketamine
The protocol includes 6 IV ketamine infusions over 4 weeks at the CHUM Neuromodulation Unit, following the Montreal Model integrating psychotherapeutic and contextual elements (e.g. preparation, music, and integration). Infusions occur twice weekly in weeks 3 and 4 of the treatment protocol, then once weekly in weeks 5 and 6. The first dose is 0.5 mg/kg in 250 mL saline over 40 minutes, with possible titration up to 1.0 mg/kg based on tolerability, clinical response, and participant preferences. Blood alcohol level is measured by breathalyzer before each session, and if any detectable alcohol is present (i.e., BAC ≠ 0%), the infusion will be postponed and rescheduled. Infusions occur in a quiet, dim room with continuous monitoring. Before each infusion, a brief mindfulness exercise promotes openness to internal experience. During the infusion, participants listen to a curated 60 minute instrumental playlist to support emotional exploration.
Canadian Sites (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for33 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Average daily ethanol consumption of at least moderate risk as per WHO risk levels (Men: \>40 to 60 g per day or \>2.9 to 4.3 drinks / Women: \>20 to 40 g per day or \>1.4 to 2.9 drinks)
- +Age 18 to 70 years
- +Provision of written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → after reading and understanding the patient information handout
- +Alcohol Use Disorder (AUD) diagnosed by a trained psychiatrist
- +Diagnosis of treatment resistant unipolar or bipolar depression, defined as failure to respond to ≥2 adequate trials per Canadian national depression guidelines
- +Willingness to engage in 8 weekly psychotherapy sessions
- +No changes to psychotropic medications during treatment
- +Bipolar or unipolar depressive episode (DSM5), current episode, with MADRS ≥ 20
- +Agreement to abstain from consuming grapefruit juice on ketamine infusion days
- +Agreement to abstain from driving or operating heavy machinery after infusions until the next day
Exclusion
- −Known intolerance or hypersensitivity to ketamine
- −Significant hearing impairment not improved by aids
- −Current participation in other evidence based psychotherapeutic interventions for mood disorders or substance abuse
- −Inability to commit to the study protocolProtocolThe detailed plan a study must follow.Read more → due to professional or personal obligations
- −Non English or non French speaking
- −Psychiatric comorbidity likely to take precedence over AUD or TRD
- −Acute psychotic disorder or acute psychotic symptoms
- −Non response to esketamine or ketamine during the current depressive episode
- −Known intellectual disability or autism spectrum disorder
- −Inability to attend regular visits to the CHUM Neuromodulation clinic
- −Depression secondary to stroke, cancer, or severe medical conditions
- −Uncontrolled hypertension or significant coronary or cerebrovascular disease
- −Renal or hepatic impairment
- −Abnormal liver function tests (AST or ALT ≥ 3 times upper normal limit)
- −Clinically significant abnormal ECG results
- −Unstable thyroid hormone levels or uncorrected hypo or hyper thyroidism
- −Any unstable or clinically significant condition judged by the study physician to interfere with treatment
- −Positive toxicology screen for drugs not prescribed
- −Unwillingness to abstain from benzodiazepines, narcotics, or NMDA antagonists (including memantine and lamotrigine) 12 hours before infusions
- −Any recent significant decline in exercise tolerance
- −Pregnant, lactating, or of childbearing potential without approved contraception use during ketamine treatment, with a negative urine pregnancy test required at baselineBaselineYour starting measurements, taken before treatment begins.Read more →
- −Risk factors for intracranial hemorrhage (trauma, aneurysm, neurosurgery)
- −Current or prior substance abuse or dependence other than AUD (except caffeine or nicotine)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Acceptance and Commitment Therapy, Ketamine.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 70 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → at 12 weeks (phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →, weeks 0 to 12) and from week 1 to week 8.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Study completion AND Adherence to ketamine infusions and ACT psychotherapy sessions — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → at 12 weeks (phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →, weeks 0 to 12) and from week 1 to week 8.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06620276 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Acceptance and Commitment TherapyBehavioural
The ACT intervention consists of eight weekly 50 minute sessions, delivered in person when possible, with virtual options available. ACT targets psychological flexibility by addressing fusion, evaluation, avoidance, and reason giving through six core processes: acceptance, values, committed action, present moment awareness, cognitive defusion, and self as context. Sessions combine didactic content and experiential exercises following a standardized manual, with therapists trained in ACT. Participants receive a workbook to support practice. Each session begins with a brief mindfulness exercise that evolves across weeks, starting with grounding and simple emotional labeling, then progressing to neutral sensory descriptions and openness to challenging sensations.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About KetamineDrug
The protocol includes 6 IV ketamine infusions over 4 weeks at the CHUM Neuromodulation Unit, following the Montreal Model integrating psychotherapeutic and contextual elements (e.g. preparation, music, and integration). Infusions occur twice weekly in weeks 3 and 4 of the treatment protocol, then once weekly in weeks 5 and 6. The first dose is 0.5 mg/kg in 250 mL saline over 40 minutes, with possible titration up to 1.0 mg/kg based on tolerability, clinical response, and participant preferences. Blood alcohol level is measured by breathalyzer before each session, and if any detectable alcohol is present (i.e., BAC ≠ 0%), the infusion will be postponed and rescheduled. Infusions occur in a quiet, dim room with continuous monitoring. Before each infusion, a brief mindfulness exercise promotes openness to internal experience. During the infusion, participants listen to a curated 60 minute instrumental playlist to support emotional exploration.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 70 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 70 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the end of the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → at 12 weeks (phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →, weeks 0 to 12) and from week 1 to week 8.
The study as a whole is currently expected to finish around 2028-06-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Alcohol use disorders (AUDs) and depressive disorders frequently coexist, complicating the clinical management of patients suffering from them. Taken separately, these two disorders have a significant prevalence in the population, and a recent meta-analysis concluded that coexistence could reach 1 in 5 patients (20.8%). This comorbidity represents a considerable challenge, particularly in cases of treatment-resistant depression (TRD), where patients do not respond to conventional pharmacological interventions. Since alcohol can act as a powerful trigger for depressive symptoms, and conversely, a depressive state increases the risk of alcohol abuse, the question of intervention sequence is also of clinical interest: should priority be given to treating TRD, AUD or both simultaneously? This question raises a major issue for healthcare professionals, as current conventional therapeutic approaches present limitations in the concomitant management of these complex disorders. Thus, in certain clinical settings, ketamine has emerged as a promising intervention to treat both TRD and AUD. In fact, ketamine has been shown to produce rapid but only transient antidepressant effects, and is part of the possible treatment arsenal for TRD. The potential of ketamine in the treatment of AUD has also been explored in recent studies, with a few small randomized controlled trials. In these trials, the combination of ketamine with psychotherapy, versus placebo, was investigated as a means of alleviating AUD. Ketamine was shown to increase abstinence rates, time to relapse and decrease the number of heavy drinking days. Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioural therapy that emphasizes psychological flexibility and acceptance of difficult emotions and thoughts without judgment, a type of psychotherapy particularly relevant to AUD. Thus, adding ACT to ketamine treatment could increase the duration of ketamine's effect on depressive symptoms, while reducing AUD. In view of this accumulated evidence of the potential benefit of ketamine and ACT, adding acceptance and commitment therapy to ketamine appears to be a promising option for improving outcomes in patients diagnosed with TRD comorbid with AUD. This study will not only verify the feasibility of this type of intervention in this particular patient population, but also the preliminary effects on their alcohol consumption and depressive symptoms.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.