Major Depressive Disorder (MDD)K-ACTNCT07906496
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
A study testing K-ACT Intervention in people with Major Depressive Disorder (MDD), run by University of British Columbia at 1 site in Canada.
Trial summary
Ketamine is often used to treat depression where standard treatments have failed. Yet, even with ketamine, depression can persist and make it difficult to keep up with life. This study examines whether it is practical, safe and helpful to use a talk therapy (Acceptance and Commitment Therapy, ACT) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- K-ACT 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
- 1 siteCanada
- Study dates
- Jan 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in this study, individuals must be eligible for and enrolled in the Ketamine Intervention Program (KIP) at UBC Hospital, an ongoing clinical program for difficult-to-treat depression, which has the following inclusion criteria:
- Be of age 18 or older.
- Have a DSM-5-TR diagnosis of major depressive disorder (MDD) or bipolar disorder (BD), in a current major depressive episode.
- If diagnosed with MDD, have failed adequate trials of at least 2 antidepressants and 1 adjunctive medication(s); if BD, having failed adequate trials of at least 3 agents for bipolar depression.
- Have a referral from a community psychiatrist who agrees to follow the patient throughout the entire trial.
- Have the ability to provide informed consent.
Who cannot join
- Individuals will not be eligible for the K-ACT study if they are deemed ineligible for enrollment with the KIP at UBC Hospital due to meeting any of the following existing exclusion criteria:
- They are experiencing active psychosis.
- They have: any of history of ketamine use disorder; a history of alcohol or other substance use disorder in the past 6 months; dementia or delirium; unstable medical conditions; uncontrolled hypertension; a history of seizures in the past 6 months; a history of elevated intracranial pressure/aneurysmal disease/arteriovenous malformation/intracranial hemorrhage.
- They are currently pregnant or breastfeeding.
- They have an allergy to ketamine.
- Currently undergoing ACT.
- Past ACT within last 12 months.
- Currently undergoing non-ACT structured psychotherapy (e.g., cognitive-behavioural therapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
UBC Hospital
Vancouver, British Columbia, V6T 2B5
Sara Lee, 604-822-7804, lam.mddresearch2@ubc.ca
About this study
Official title: Recovery-focused Acceptance and Commitment Therapy Combined With Ketamine (K-ACT) for Patients With Difficult-to-treat Depression: a Feasibility Study.
Ketamine is often used to treat depression where standard treatments have failed. Yet, even with ketamine, depression can persist and make it difficult to keep up with life. This study examines whether it is practical, safe and helpful to use a talk therapy (Acceptance and Commitment Therapy, ACT) in patients with difficult-to-treat depression receiving ketamine through the Ketamine Intervention Program at UBC Hospital. Researchers expect that combining ACT plus Ketamine ("K-ACT") will be feasible, safe, and will help patients functioning better in their daily lives, feeling that they are recovering, and having fewer symptoms of depression.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- K-ACT Intervention
- Keywords
- Acceptance and Commitment Therapy (ACT), ketamine, depression, difficult-to-treat (DTD) depression
- Medical subject headings
- Depressive Disorder, Major, Depression, Diastrophic dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-ACT InterventionBehavioural
Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention that aims to help people develop acceptance of their experiences, awareness of the present moment, distance ("defusion") from one's thoughts/emotions, clarification of one's values, commitment to actions consistent with those values, and flexible experience of self. Through these processes, participants can develop better psychological flexibility, which in turn can support depression recovery.
In this study, ACT is provided in parallel to a ongoing clinical ketamine treatment program for depression, within a Ketamine-Combined with Psychotherapy (KCP) framework.
| Study group | Role | What they receive |
|---|---|---|
| K-ACT Intervention | Experimental | Not described Receives: Behavioral: K-ACT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes
Rate of recruitment/total participants enrolled, treatment attendance (sessions attended), retention, and follow-up completion
Measured: 18 months/end of study
Safety outcomes
Participant safety will be monitored through routine clinical assessments, including ongoing evaluation of suicidality and adverse events.
Measured: 18 months/end of study
Secondary outcomes (4)
Change in Work and Social Adjustment Scale (WSAS)
The Work and Social Adjustment Scale (WSAS) is a measure of functioning. It is a short 5-items self-reported scale. Each item is scored 0 to 8. The higher the score, the greater the functional impairment.
Measured: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Change in Questionnaire about the Process of Recovery (QPR-15)
The Questionnaire about the Process of Recovery (QPR-15) is a self-reported scale on personal recovery. There are 15 items rated on a scale from 0 to 4 (0= disagree strongly, 1=disagree, 2=neither agree nor disagree, 3=agree, 4=agree strongly). Higher scores indicate greater recovery.
Measured: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments).
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale to rate the severity of depression. Items are scored from 0 to 6. The total possible score is 60. Higher scores indicate greater depression severity.
Measured: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Change in Acceptance and Commitment Questionnaire (AAQ-II)
The Acceptance and Commitment Questionnaire (AAQ-II) is a measure of psychological flexibility. It is a self-reported scale with 7 items, each scored on a 7-points scale. Higher values indicate less flexibility, while lower scores more flexibility.
Measured: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Respino, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906496
- Sponsor's protocol ID
- H26-02512
- Acronym
- K-ACT
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery-focused Acceptance and Commitment Therapy Combined With Ketamine (K-ACT) for Patients With Difficult-to-treat Depression: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT07906496
- Acronym / sponsor ID
- K-ACT / H26-02512
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Acceptance and Commitment Therapy (ACT), ketamine, depression, difficult-to-treat (DTD) depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Oct 2026 (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.
Ketamine is often used to treat depression where standard treatments have failed. Yet, even with ketamine, depression can persist and make it difficult to keep up with life. This study examines whether it is practical, safe and helpful to use a talk therapy (Acceptance and Commitment Therapy, ACT) in patients with difficult-to-treat depression receiving ketamine through the Ketamine Intervention Program at UBC Hospital. Researchers expect that combining ACT plus Ketamine ("K-ACT") will be feasible, safe, and will help patients functioning better in their daily lives, feeling that they are recovering, and having fewer symptoms of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-ACT Intervention | Experimental | Behavioral: K-ACT Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To participate in this study, individuals must be eligible for and enrolled in the Ketamine Intervention Program (KIP) at UBC Hospital, an ongoing clinical program for difficult-to-treat depression, which has the following inclusion criteria:
- Be of age 18 or older.
- Have a DSM-5-TR diagnosis of major depressive disorder (MDD) or bipolar disorder (BD), in a current major depressive episode.
- If diagnosed with MDD, have failed adequate trials of at least 2 antidepressants and 1 adjunctive medication(s); if BD, having failed adequate trials of at least 3 agents for bipolar depression.
- Have a referral from a community psychiatrist who agrees to follow the patient throughout the entire trial.
Key exclusion criteria (8 listed)
- Individuals will not be eligible for the K-ACT study if they are deemed ineligible for enrollment with the KIP at UBC Hospital due to meeting any of the following existing exclusion criteria:
- They are experiencing active psychosis.
- They have: any of history of ketamine use disorder; a history of alcohol or other substance use disorder in the past 6 months; dementia or delirium; unstable medical conditions; uncontrolled hypertension; a history of seizures in the past 6 months; a history of elevated intracranial pressure/aneurysmal disease/arteriovenous malformation/intracranial hemorrhage.
- They are currently pregnant or breastfeeding.
- They have an allergy to ketamine.
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 |
|---|---|---|
| K-ACT InterventionAcceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention that aims to help people develop acceptance of their experiences, awareness of the present moment, distance ("defusion") from one's thoughts/emotions, clarification of one's values, commitment to actions consistent with those values, and flexible experience of self. Through these processes, participants can develop better psychological flexibility, which in turn can support depression recovery. In this study, ACT is provided in parallel to a ongoing clinical ketamine treatment program for depression, within a Ketamine-Combined with Psychotherapy (KCP) framework. | Behavioural | K-ACT Intervention |
Primary outcome
Feasibility outcomes
Time frame: 18 months/end of study
Rate of recruitment/total participants enrolled, treatment attendance (sessions attended), retention, and follow-up completion
Safety outcomes
Time frame: 18 months/end of study
Participant safety will be monitored through routine clinical assessments, including ongoing evaluation of suicidality and adverse events.
4 secondary outcomes
Change in Work and Social Adjustment Scale (WSAS)
Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Change in Questionnaire about the Process of Recovery (QPR-15)
Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments).
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Change in Acceptance and Commitment Questionnaire (AAQ-II)
Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-ACT Intervention in people with Major Depressive Disorder (MDD), run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Lee (604-822-7804, lam.mddresearch2@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (time frame: 18 months/end of study). The study lists 2 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 30 Oct 2026.