Esketamine clinics with supervised monitoring

1. Introduction

Version followed: the US SPRAVATO (esketamine) prescribing information and REMS as described by FDA and the manufacturer (label 2020 version opened; January 2025 monotherapy approval; REMS modifications through June 2026), the UK SmPC (revised 18 July 2025), and the published psychological-support recommendations of Breeksema et al. (2022) and the integration-therapy arm of trial NCT07369102. Drug quantities, routes, frequencies and administration steps are deliberately left out; they belong to the prescriber and the label.

What it is. An esketamine clinic is a service model, not a psychotherapy. Esketamine (brand SPRAVATO, Janssen / Johnson & Johnson) is a prescription antidepressant given only in a medically supervised, certified healthcare setting, where a healthcare provider directly observes the patient during and after each treatment session until the patient is clinically stable and ready to leave. Neither the label nor the manufacturer prescribes any psychotherapy; one US payer protocol states explicitly that psychotherapy is not required. [source: FDA label 2020; J&J Medical Connect REMS page; CBH Spravato procedures 2026]

Indications (US, as of the January 2025 release). Adults with treatment-resistant depression (inadequate response to at least two oral antidepressants), either alone or with an oral antidepressant; and depressive symptoms in adults with major depressive disorder with acute suicidal thoughts or actions, together with an oral antidepressant. It is not a substitute for hospitalisation when hospitalisation is clinically needed, and it has not been shown to prevent suicide. [source: J&J press release 21 Jan 2025]

Core idea of how change happens. The label frames benefit pharmacologically and offers no psychological change model. The psychotherapy literature on this setting adds a second idea: how patients are prepared, supported and debriefed shapes whether the transient dissociative state is experienced as overwhelming or as tolerable or even meaningful, and the period around treatment may be a window in which psychotherapy (e.g. trauma-focused CBT or EMDR) takes hold more easily. These are hypotheses from small qualitative and open-label studies, not established mechanisms. [source: Breeksema et al. 2022; Rothärmel et al. 2022] [uncertain]

Where a psychotherapist fits. A psychotherapist may (a) refer and co-treat a client receiving esketamine elsewhere, (b) work inside a certified clinic delivering preparation, supportive presence and integration alongside the medical monitoring team, or (c) provide adjunctive psychotherapy scheduled around treatment sessions. Medical screening, administration, vital-sign monitoring and discharge decisions are the responsibility of the prescriber and medical staff and are not described technically here. [synthesis, built on the sources above]

Legal and regulatory status (as of the sources' dates).

USA: Federally controlled (Schedule III). Available only through the SPRAVATO REMS (Risk Evaluation and Mitigation Strategy), whose stated goal is to reduce serious adverse outcomes from sedation and dissociation and to reduce abuse and misuse. Only certified healthcare settings and certified pharmacies may handle it; patients treated in outpatient settings must be enrolled; it must never be dispensed to a patient for home use; a healthcare provider monitors the patient for a minimum observation period (stated as at least two hours) and decides when the patient may leave. The REMS was first approved 5 March 2019 and modified on 23 January 2026, 13 April 2026 (adding Spanish translations of REMS materials) and 24 June 2026 (revised website workflows). The content of the January 2026 modification was not verified. [source: FDA label 2020; J&J REMS page; J&J release 2025; FDA letters S-028, S-029] [uncertain: current enrollment and form requirements; check spravatorems.com]
UK: Licensed (SmPC revised July 2025) for treatment-resistant MDD with an SSRI or SNRI, and for acute short-term treatment of a moderate to severe episode that constitutes a psychiatric emergency. The decision to prescribe should be made by a psychiatrist, and treatment takes place under direct supervision of a healthcare professional in an appropriate clinical setting. NICE (TA854) does not recommend it for NHS funding in England and in 2024 declined to re-appraise it. J&J states it is available in Scotland and in about 20 other European countries, including Ireland. [source: UK SmPC; pharmaphorum 2024] [uncertain: SMC decision and EU-wide authorisation details]
Racemic ketamine: Use of generic (racemic) ketamine for depression is a separate, off-label practice that sits outside the SPRAVATO REMS. Its regulatory details are not covered here. [uncertain]

2. Framework

The sources describe a treatment pathway, not psychotherapy phases. The phase names below are organising labels for the clinician. [synthesis, built on label, SmPC, CBH and NCT07369102]

Phase A: Referral and eligibility.

Goal: confirm the diagnosis, treatment resistance or acute suicidality, medical suitability and readiness for the logistical commitment.
Format: psychiatric assessment by the prescriber; medical review by medical staff; structured measures.
Move on when: the prescriber has cleared the patient, there are no contraindications, and the patient understands the time, energy and transport demands. CBH asks that members have a clear understanding of these demands before starting. [source: CBH 2026; label; SmPC]

Phase B: Enrollment, consent and preparation.

Goal: REMS enrollment where required; informed consent covering sedation, dissociation, blood-pressure rises, misuse potential, cognitive and bladder effects, the driving restriction and the observation requirement; psychological preparation.
Format: one or more visits. The trial integration arm uses brief, manualised preparation sessions given by trained clinicians; the manual is not named publicly. [source: label; NCT07369102 via moreblossom listing] [uncertain: session count and content]
Move on when: consent is documented, a transport plan exists, and the patient can describe what to expect and how to signal distress. [synthesis]

Phase C: Supervised treatment sessions (acute, then maintenance).

Goal: safe administration and observation. Each visit includes a pre-treatment check by medical staff, administration under direct observation, and observation until the patient is clinically stable and ready to leave.
Format: individual sessions in a dedicated room or area with a chair (single-chair private room or shared multi-chair space). The prescriber sets how often and how long sessions run, following the label. [source: label; CBH 2026; SmPC]
Each session ends when: medical staff judge the patient clinically stable and ready to leave, and a driver or companion takes them home. [source: label; SmPC; J&J 2025]

Phase D: Integration and adjunctive psychotherapy (in parallel with C).

Goal: debrief experiences, consolidate gains, and address depression, trauma and life problems.
Format: brief integration sessions after each treatment session in the NCT07369102 arm. In Rothärmel et al., trauma-focused CBT and/or EMDR sessions were held within one week of treatment sessions and began on average several months after esketamine started. [source: NCT07369102 listing; Rothärmel et al. 2022]

Phase E: Review, continuation or discontinuation.

Goal: measurement-based review (PHQ-9, C-SSRS, mental status examination at every visit); the prescriber decides whether to continue, adjust or stop; plan relapse prevention and ongoing psychotherapy. [source: CBH 2026; label] [synthesis for relapse-prevention planning]

3. Guiding principles

Medical safety is the medical team's job. The therapist never takes over vital-sign monitoring, administration or discharge decisions; they flag concerns to medical staff. [source: label; SmPC; CBH]
Directly observed, never take-home. Every session happens in the certified setting; requests for home supply are refused and explored clinically. [source: J&J REMS page]
Stable before leaving. Nobody leaves until medical staff judge them clinically stable and ready, and nobody drives until the next day after restful sleep. [source: label; SmPC; J&J 2025]
Thorough preparation prevents overwhelm. Explain the timing, nature, intensity and unpredictability of effects before the first session. [source: Breeksema et al. 2022]
Use neutral language. Describe dissociation as an expected, transient effect rather than loading it with negative words, while still giving honest warnings. [source: Breeksema et al. 2022]
Letting go rather than fighting. Patients cope better when they are prepared to accept loss of control than when they resist it; teach this stance in advance. [source: Breeksema et al. 2022]
Be present, especially early. Staff should be physically present, particularly in the first sessions. [source: Breeksema et al. 2022]
Low stimulus, few interruptions. A private, warm, comfortable room where the patient can lie down, with as few measurements and interruptions at peak effect as medical safety allows. [source: Breeksema et al. 2022]
Touch only by prior agreement. Hand-holding helped some patients, but only after it had been discussed beforehand. [source: Breeksema et al. 2022]
Take experiences seriously. Listen to and debrief what patients report, including fleeting or transformative experiences. [source: Breeksema et al. 2022]
Measure every visit. Use a mental status examination, PHQ-9 and C-SSRS before and during treatment. [source: CBH 2026]
Watch for misuse. Assess abuse and misuse risk before starting and monitor for drug-seeking throughout. [source: SmPC; J&J 2025]
Suicidality needs close supervision. This is especially true early in treatment and after any change in treatment; esketamine does not replace hospitalisation. [source: SmPC; J&J 2025]
Continuity of carer. One named nurse or clinician follows the patient throughout. [source: Rothärmel et al. 2022]
Coordinate care. Have processes for clients referred from, or seen at the same time by, other services. [source: CBH 2026]
Stay in scope. The clinic is not a psychedelic-therapy setting, so do not import high-intensity experiential techniques into the observation period. [synthesis]

4. Intervention inventory

The published sources describe clinic procedures and psychological-support practices, not a named psychotherapy with branded techniques. The procedures below are those the sources describe; anything added is marked [synthesis]. Where the therapist works alongside a medical team, tasks are labelled by owner.

4.1 Referral and suitability assessment (therapist contributes; prescriber decides)

Purpose / when: before referral, or at intake to a clinic, to see whether the client fits the indications and is likely to tolerate and benefit from the clinic format. [source: J&J 2025; SmPC; CBH 2026]
Steps: (1) Document the depressive episode and previous antidepressant trials so the prescriber can judge treatment resistance (two or more inadequate responses). (2) Screen for psychosis, mania and bipolar history; the label asks for careful assessment of psychosis, the SmPC for caution in psychosis, mania and bipolar disorder, and the NCT07369102 trial excluded primary psychotic disorders and manic-phase bipolar I. (3) Screen substance use (see 4.3). (4) Assess suicide risk (see 4.4). (5) Assess practical capacity: someone to drive the client home after every session, time away from work, and the ability to wait through the observation period. (6) Send a referral summary to the prescriber. [source: label; SmPC; NCT07369102 listing; CBH 2026] [synthesis for the sequencing]
Example language (illustrative): "This treatment means coming in to a clinic, staying there for a couple of hours afterwards, and having someone take you home each time. Before we think about whether it suits you, let's look at whether that's workable."
Watch for: a client hoping esketamine will replace needed inpatient care (it does not); unrealistic expectations of a cure; a history of psychosis that has not been disclosed. [source: J&J 2025; label]

4.2 Medical screening and contraindications (medical staff)

Purpose / when: before treatment starts and before each session; this is a medical responsibility, listed here so the therapist knows what will be asked and can pass on relevant history.
What the sources list: contraindications are aneurysmal vascular disease (intracranial, thoracic or abdominal aorta, or peripheral arteries), arteriovenous malformation, a history of intracerebral haemorrhage, hypersensitivity to esketamine or ketamine, and (UK SmPC) a cardiovascular event such as myocardial infarction within the past six weeks. Conditions needing careful assessment include cardiovascular and cerebrovascular disease, uncontrolled hypertension, a history of hypertensive encephalopathy, significant pulmonary insufficiency including COPD, sleep apnoea with high BMI, uncontrolled arrhythmia, severe heart failure or valvular disease, untreated hyperthyroidism, brain injury or raised intracranial pressure, severe hepatic impairment, pregnancy (embryo-fetal risk; breastfeeding not recommended) and, in older adults, fall risk. Where cardiovascular or respiratory conditions are significant, the SmPC asks for treatment where resuscitation equipment and trained staff are available. Blood pressure is checked before each session, and the session is withheld if a rise would pose serious risk. Rothärmel et al. also obtained baseline blood tests and an ECG. [source: label 2020; SmPC 2025; Rothärmel et al. 2022]
Therapist's role: pass on any known history of these conditions; never reassure a client about medical eligibility yourself. [synthesis]
Watch for: new pregnancy, newly diagnosed vascular disease, or new medications (especially other CNS depressants, which the SmPC links to rare respiratory depression). Pass these to the prescriber immediately. [source: SmPC]

4.3 Substance-use and misuse-risk assessment

Purpose / when: at baseline and throughout, because esketamine is a controlled substance with abuse, misuse and diversion potential. [source: SmPC; J&J 2025; label]
Steps: (1) Take a substance-use history, including any past ketamine or other dissociative use. (2) For clients with substance use disorders, regularly assess for active use and educate them about the benefits of SUD treatment. (3) Monitor for drug-seeking: requests for more frequent sessions, for take-home supply, or for a different formulation obtained elsewhere. (4) Feed observations back to the prescriber. [source: CBH 2026; SmPC; J&J 2025] NCT07369102 excluded moderate to severe SUD in the past six months; this is a trial criterion, not a label requirement. [source: NCT07369102 listing]
Example language (illustrative): "Because this medicine can be misused, we ask everyone about alcohol and drugs, including ketamine. It isn't a judgement; it helps us keep the treatment safe."
Watch for: craving for the session state, minimising other substance use, or interest in obtaining ketamine outside the clinic (see 4.18).

4.4 Suicide-risk assessment and measurement-based monitoring

Purpose / when: at every visit. One indication is MDD with acute suicidal ideation or behaviour, and the SmPC asks for close supervision, especially early and after any change in treatment. [source: CBH 2026; SmPC; J&J 2025]
Steps: (1) Do a mental status examination at each visit. (2) Administer the PHQ-9 and C-SSRS before and during treatment; use licensed versions and do not improvise items. (3) Screen health-related social needs. (4) Keep a written safety plan up to date and use lethal-means counselling (safe storage and removal). (5) If imminent risk is present, arrange emergency or inpatient care; esketamine is not a substitute for hospitalisation. (6) Share results with the prescriber. [source: CBH 2026; J&J 2025] [synthesis for steps 4 to 5, following standard practice]
Example language (illustrative): "Some people feel better quickly and some don't, and mood can swing early on. I'll check in about suicidal thoughts every visit, so it never feels like an odd question."
Working if: scores and the mental status examination are tracked and acted on; deterioration triggers a same-day review rather than waiting for the next scheduled session. [synthesis]

4.5 Informed consent and REMS education

Purpose / when: before the first session; repeat key points whenever the treatment plan changes. [source: label; J&J REMS page]
Steps: (1) Explain that treatment happens only in a certified setting under direct observation and is never given to take home. (2) Explain enrollment in the REMS where it applies. (3) Cover the main effects in plain words: sedation; dissociation, including altered sense of time and space, illusions, derealisation and depersonalisation, usually short-lived and confined to the treatment day; dizziness, vertigo, nausea, anxiety, numbness and feeling drunk; transient rises in blood pressure; possible short- and longer-term effects on thinking and memory; bladder symptoms such as urgency, pain on urination or night-time urination, which should be reported; misuse and dependence potential; and embryo-fetal risk. (4) State the observation requirement and that medical staff decide when the patient can leave. (5) State the rule: no driving, machinery or other activities that need full alertness until the next day after restful sleep, and arrange a driver. (6) Check understanding with teach-back and document consent. [source: label 2020; J&J 2025; SmPC] [synthesis for teach-back]
Example language (illustrative): "During the session you may feel detached from your body or your surroundings, or time may seem strange. That usually passes within the visit. A staff member stays with you, and you won't leave until they're sure you're steady."
Watch for: a client who hears only the hopeful parts. Ask them to repeat the driving rule and the observation requirement in their own words.

4.6 Psychological preparation session(s)

Purpose / when: before the first treatment session and again before any change that may intensify effects. Breeksema et al. found that inadequate preparation was a central theme in patients' experiences of being overwhelmed. [source: Breeksema et al. 2022]
Steps: (1) Describe the timing, nature, intensity and unpredictability of effects. (2) Use neutral terms: call dissociation an "effect" or "experience", not a frightening side effect, while still being honest. (3) Manage expectations: effects vary between sessions, and mood on the day can colour the session. (4) Coach a calm, open stance toward letting go of control instead of fighting it. (5) Teach one or two simple breathing or mindfulness anchors to practise beforehand. (6) Agree how the client will signal distress, and whether any touch (such as hand-holding) is welcome. (7) Discuss music and headphones. (8) Identify a supportive person who can accompany them or be available at home afterwards. [source: Breeksema et al. 2022] The NCT07369102 arm uses brief manualised preparation before each dosing session to support emotional processing and engagement; its content is not public. [source: NCT07369102 listing] [uncertain]
Example language (illustrative): "If things start to feel strange or out of control, try not to wrestle with it. Notice your breath, let the feeling pass through, and remember a nurse is right there. If you want help, just raise your hand."
Watch for / working if: the client can describe what may happen and their coping plan; anticipatory anxiety drops; at debrief they report feeling prepared. [synthesis]

4.7 Logistics and day-of-treatment safety planning

Purpose / when: before every session. [source: label; J&J 2025; CBH 2026]
Steps: (1) Confirm the driver or companion who will take the client home. (2) Plan the rest of the day without driving, operating machinery or safety-critical work until the next day after restful sleep. (3) Follow the pre-session instructions the prescribing team gives. (4) Use transport support where available (e.g. CBH points members to the Medical Assistance Transportation Program). [source: label; SmPC; J&J 2025; CBH 2026]
Example language (illustrative): "Who's picking you up today, and what's the plan for this evening, so you're not tempted to drive?"
Watch for: missed sessions because of transport problems, or plans to drive or work a shift after treatment. Problem-solve these before the day. [synthesis]

4.8 Setting design

Purpose / when: set up once and check before every session. [source: Breeksema et al. 2022; CBH 2026]
Steps: (1) Provide a dedicated room or area with a reclining chair or couch; CBH allows a private single-chair room or a shared multi-chair space. (2) Keep it private, warm rather than clinical, low-stimulus and comfortable, with room to lie back. (3) Offer calming music and, where possible, noise-cancelling headphones. (4) Keep interruptions and measurements to the minimum medical staff consider safe during peak effects. (5) Make sure resuscitation equipment and trained staff are available where the client's medical profile requires them. [source: Breeksema et al. 2022; CBH 2026; SmPC] Eyeshades are not mentioned in the sources. [uncertain]
Watch for: shared spaces where other patients' distress or staff conversation intrudes; adjust seating, use screens or headphones. [synthesis]

4.9 Supportive presence during the observation period

Purpose / when: throughout every session, especially the first ones. Patients in Breeksema et al. valued staff presence and emotional support. [source: Breeksema et al. 2022; label]
Steps: (1) Build rapport before the session starts. (2) Stay physically present, or within immediate reach, particularly in early sessions; medical observation itself remains with designated medical staff. (3) Speak little and calmly; let the client lead. (4) Offer touch, such as hand-holding, only where it was agreed in advance; otherwise use voice. (5) Take whatever the client reports seriously, without interpreting it in the moment. (6) Note what the client says for later debrief. [source: Breeksema et al. 2022; label; CBH 2026] CBH allows appropriately trained medical staff, including licensed trainees, to act as monitors; whether a non-medical psychotherapist can count as the REMS monitor depends on the setting's certification and local scope rules. [source: CBH 2026] [uncertain]
Example language (illustrative): "I'm right here. You don't need to do anything; just let it be."
Watch for: rising panic, confusion, unusual drowsiness or physical complaints. Alert medical staff at once and do not manage these yourself. Avoid structured trauma processing or confrontational work while the client is dissociated or sedated. [synthesis]

4.10 Coping with loss of control (in-session)

Purpose / when: when the client struggles against dissociation or becomes anxious. [source: Breeksema et al. 2022]
Steps: (1) Remind them of the preparation: the effect is temporary and they are being watched over. (2) Invite the agreed stance of letting go rather than holding on. (3) Cue the practised breathing or mindfulness anchor. (4) Offer music or headphones, or remove them if they are adding to distress. (5) If distress persists or escalates, involve medical staff. [source: Breeksema et al. 2022] [synthesis for steps 4 to 5]
Example language (illustrative): "This is the medicine working, and it will ease. Breathe out slowly. You're safe in the chair."
Working if: the client settles, and at debrief describes the experience as manageable. [synthesis]

4.11 Observation and discharge readiness (medical staff)

Purpose / when: after every administration, for the full REMS observation period and longer if needed. [source: label; J&J 2025; SmPC]
What the sources describe: a healthcare provider observes the patient for sedation, dissociation and blood-pressure changes until they are clinically stable and judged ready to leave; patients with relevant histories may need more intensive monitoring; blood pressure that stays raised is managed by experienced practitioners, and symptoms of hypertensive crisis need emergency care; older adults are watched for falls when they first get up. [source: label 2020; SmPC 2025]
Therapist's role: never tell a client they may leave; report anything that seems off; check that the companion is present. [synthesis]

4.12 Session documentation

Purpose / when: every session. [source: CBH 2026]
What CBH requires in the record: the administration record kept by medical staff, the exact start and end times of monitoring, the monitoring parameters or tools used, the member's response, confirmation that REMS documentation was completed and submitted, and the monitoring staff's signature and credentials. [source: CBH 2026]
Therapist addition (illustrative): a short note of the client's subjective experience, any distress and how it was handled, and themes for integration. [synthesis]

4.13 Post-session debrief and integration

Purpose / when: before the client leaves, at the next appointment, or in a dedicated integration session. Breeksema et al. recommend clinicians be available to help patients debrief, recall fleeting experiences and talk through overwhelming or transformative ones. [source: Breeksema et al. 2022] NCT07369102 provides brief manualised integration sessions after each dosing session, aimed at emotional processing, meaning-making and therapeutic engagement. [source: NCT07369102 listing] [uncertain: manual content]
Steps: (1) Once medical staff confirm stability, ask open questions about what happened. (2) Help the client put fragmentary impressions into words. (3) Separate what the experience means to them from what it predicts. (4) Link what emerged to the treatment goals: mood, hopelessness, relationships, avoidance. (5) Agree one small action or reflection for the coming days. (6) Note recurring themes for psychotherapy. [source: Breeksema et al. 2022; NCT07369102 listing] [synthesis for steps 3 to 6]
Example language (illustrative): "What stood out for you today? Even small fragments count. And is there anything from it you'd like to take into the week?"
Watch for / working if: the client can describe the session coherently, feels heard, and reports engagement with goals; distressing material is contained rather than left open at the end of the visit. [synthesis]

4.14 Adjunctive psychotherapy timed around treatment

Purpose / when: when residual depression, trauma or life problems need structured psychotherapy. [source: Rothärmel et al. 2022]
What the source describes: in a small open-label pilot in France (TRD with comorbid chronic PTSD), voluntary trauma-focused CBT, EMDR or both were scheduled within one week of esketamine sessions. Therapists observed easier fear reduction and new positive associations. Some patients in a trance-like dissociative state put a traumatic experience into words for the first time. The authors suggest supporting patients before and during the first sessions to improve tolerance, and starting trauma-focused therapy later, once patients have adjusted to the subjective effects and to early benefits. [source: Rothärmel et al. 2022] Both the source and this guide treat the findings as exploratory. [uncertain]
Steps: (1) Choose an evidence-based psychotherapy for the presenting problem (e.g. CBT, EMDR); deliver it on separate days, not during the observation period. (2) Hold off trauma-focused work until the client tolerates sessions well. (3) Review measures before and after each block of therapy (the pilot used the PCL-5 for PTSD symptoms). [source: Rothärmel et al. 2022] [synthesis for step 1's separation rule]
Example language (illustrative): "Now that the sessions feel more manageable, this may be a good time to start working on the memories we've been putting to one side."

4.15 Involving partners and support persons

Purpose / when: at preparation, and on treatment days. Breeksema et al. suggest partners or friends can help during sessions and at home. [source: Breeksema et al. 2022]
Steps: (1) With consent, brief the companion on expected effects, the driving rule and warning signs. (2) Agree their role: driver, calm presence, someone to call. (3) Give them the clinic contact and emergency routes. [source: Breeksema et al. 2022; label] [synthesis for steps 1 and 3]
Example language (illustrative): "It helps if the person collecting you knows you may be a bit tired or spaced-out this evening, and that you shouldn't drive until tomorrow."

4.16 Care coordination

Purpose / when: whenever the client is referred from, or is also seen by, other services. [source: CBH 2026]
Steps: (1) Agree with consent who holds the overall treatment plan. (2) Share risk information, measures and changes in mental state with the prescriber. (3) Agree who does what in a crisis. [source: CBH 2026] [synthesis for steps 1 to 3]

4.17 Ongoing monitoring of longer-term risks

Purpose / when: throughout treatment. [source: label; SmPC]
Steps: (1) Ask regularly about bladder symptoms, memory or thinking changes, drug-seeking and new substance use. (2) Refer to the prescriber when symptoms persist; the SmPC asks for urological referral for persistent urinary symptoms. (3) Remind people of reproductive potential about embryo-fetal risk and the need to report pregnancy. [source: label 2020; SmPC 2025]

4.18 Harm reduction for clients using ketamine outside a clinic [synthesis]

Purpose / when: when a client reports, or is considering, using ketamine outside regulated care. The sources do not address this. The guidance below is the author's synthesis.
Steps: (1) Ask non-judgementally and assess frequency, context and consequences. (2) Give general risk education only: dissociation and accidents, bladder damage, dependence, interactions with alcohol and other sedatives, and not driving. Give no dosing, sourcing or preparation advice. (3) Make a safety plan: never alone, no driving, and know when to call emergency services. (4) Offer referral to regulated treatment (a certified esketamine setting or SUD services). (5) Offer integration support for experiences the client has already had, without facilitating further use. [synthesis]
Example language (illustrative): "I'm not going to lecture you, and I can't advise on how to use it. I do want you to be safe, so let's look at the risks and what a regulated option might look like."

5. Handling problems

The sources say little about psychotherapeutic problem-handling. Items marked [synthesis] are the author's guidance.

Overwhelming dissociation or panic in session. The sources list overwhelming experiences and inadequate preparation as central patient themes. Respond with calm presence, the agreed letting-go stance and breathing anchor, and adjust music or headphones; involve medical staff if distress persists or physical symptoms appear. Afterwards, review the preparation and repeat it before the next session. [source: Breeksema et al. 2022] [synthesis for the review step]
Anticipatory dread before later sessions. Debrief what was frightening, normalise variability between sessions, rehearse coping, and offer more staff presence or, if previously agreed, hand-holding. If dread stays high, discuss with the prescriber whether to continue. [synthesis, drawing on Breeksema et al. 2022]
Traumatic material surfacing while dissociated. Do not deepen or process it in the observation period. Ground the client, note the content, and contain it at debrief. Bring it into scheduled trauma-focused therapy once the client tolerates sessions well. [source: Rothärmel et al. 2022 on surfacing and on timing] [synthesis for in-session handling]
Worsening suicidality or a crisis between sessions. Do a same-day risk assessment and update the safety plan and lethal-means counselling; arrange emergency or inpatient care if needed, since esketamine is not a substitute for hospitalisation; inform the prescriber. [source: J&J 2025; SmPC] [synthesis for steps]
Emerging psychotic or manic symptoms. Stop and refer to the prescriber urgently; the sources ask for careful assessment or caution in these conditions. [source: label; SmPC]
Non-response. Use measures to show the trajectory; the prescriber decides about continuation. Explore beliefs such as "I'm untreatable", and make sure evidence-based psychotherapy and social-needs support are in place. [source: CBH 2026 for measures] [synthesis]
Non-adherence and missed sessions. Common causes are transport, time off work, cost and coverage, and fear. Problem-solve rides (CBH points members to MATP), schedule around work, check coverage, and address fear through preparation. In England, NHS access is limited because NICE does not recommend it. [source: CBH 2026; pharmaphorum 2024] [synthesis]
Plans to drive or leave early. Restate the rule: medical staff decide when the patient may leave, and no driving until the next day after restful sleep. Confirm the companion before treatment begins. [source: label; J&J 2025]
Requests for take-home supply, extra sessions or "something stronger". Explain that the REMS forbids home dispensing; explore what the request is about (craving, avoidance, wanting to escape); assess for misuse and inform the prescriber. [source: J&J REMS page; SmPC] [synthesis for exploration]
Ruptures: feeling unheard, rushed or treated as "just another chair to monitor". Breeksema et al. stress taking experiences seriously and building rapport. Name the rupture, apologise for anything you got wrong, schedule time to debrief, and give continuity through one named nurse or clinician. [source: Breeksema et al. 2022; Rothärmel et al. 2022] [synthesis for repair steps]
Client wants "psychedelic-style" deep work. Explain that this is a medically monitored antidepressant service, not psychedelic-assisted psychotherapy; offer integration and evidence-based psychotherapy instead; do not add high-intensity experiential methods during observation. [synthesis]
Shared multi-chair rooms reducing privacy. Use screens, headphones and seating choices; limit staff conversation. [source: CBH 2026 for room types; Breeksema et al. 2022 for privacy] [synthesis]
Scope confusion for non-medical therapists. Check the setting's REMS certification and local rules on who may act as monitor; never make medical or discharge calls. [source: CBH 2026] [uncertain]
Bladder, cognitive or blood-pressure concerns raised in therapy. Refer to the prescriber promptly. [source: label; SmPC]
Client also using ketamine outside a clinic. Follow 4.18: harm reduction, general risk education, no dosing advice, and referral. [synthesis]

Sources

Sources:

Papers and documents cited:

Breeksema JJ, Niemeijer A, Kuin B, Veraart J, Kamphuis J, Schimmel N, van den Brink W, Vermetten E, Schoevers RA (2022). Holding on or letting go? Patient experiences of control, context, and care in esketamine treatment for treatment-resistant depression: a qualitative study. Frontiers in Psychiatry 13:948115. (Off-label programme in the Netherlands using a different formulation from SPRAVATO; recommendations applied here by analogy.) [uncertain transferability]
Rothärmel M, Benosman C, El-Hage W, Berjamin C, Ribayrol D, Guillin O, Gaillard R, Berkovitch L, Moulier V (2022). Frontiers in Psychiatry 13:865466.
NICE (2020; reviewed 2024). TA854: Esketamine for treatment-resistant depression (status from pharmaphorum). [uncertain]

Further reading (not drawn on; not verified): the current REMS document and spravatorems.com materials (enrollment and monitoring-form details after the January 2026 modification), the EMA EPAR, the SMC decision, and the regulatory status of racemic ketamine. [uncertain]

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