ClinicalTrials.gg
Not yet recruitingNCT07906496K-ACTUpdated Oct 30, 2026

Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.

An interventional study of K-ACT Intervention in Major Depressive Disorder (MDD), sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Major Depressive Disorder (MDD)

Keywords

  • Acceptance and Commitment Therapy (ACT)
  • ketamine
  • depression
  • difficult-to-treat (DTD) depression
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 50 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

  1. Be of age 18 or older.
  2. Have a diagnosis of major depressive disorder (MDD) or bipolar disorder (BD), in a current major depressive episode.
  3. 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.
  4. Have a referral from a community psychiatrist who agrees to follow the patient throughout the entire trial.
  5. Have the ability to provide .

Exclusion criteria

Exclusion Criteria:

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:

  1. They are experiencing active psychosis.
  2. 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.
  3. They are currently pregnant or breastfeeding.
  4. They have an allergy to ketamine.

Exclusion criteria specific to the K-ACT study include:

  1. Currently undergoing ACT.
  2. Past ACT within last 12 months.
  3. Currently undergoing non-ACT structured psychotherapy (e.g., cognitive-behavioural therapy).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    K-ACT Intervention

    Behavioral: K-ACT Intervention

Interventions

  • BehavioralK-ACT Intervention

    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.

06

What researchers measure

Primary outcomes

  1. Feasibility outcomes

    Rate of recruitment/total participants enrolled, treatment attendance (sessions attended), retention, and follow-up completion

    Time frame: 18 months/end of study

  2. Safety outcomes

    Participant safety will be monitored through routine clinical assessments, including ongoing evaluation of suicidality and adverse events.

    Time frame: 18 months/end of study

Secondary outcomes

  1. 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.

    Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)

  2. 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.

    Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments).

  3. 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.

    Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)

  4. 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.

    Time frame: Changes from baseline to 3-month follow-up (3 months post completion of acute/index ketamine treatments)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906496
Responsible party
Matteo Respino (Clinical Assistant Professor, UBC Department of Psychiatry, University of British Columbia) — Principal investigator
First posted
Oct 30, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Sara Lee
Contact
lam.mddresearch2@ubc.ca
604-822-7804

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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