A pilot study of Behaviour Activation Therapy combined with ketamine treatment for people with treatment-resistant depression

A co-produced behaviour activation therapy used as an adjunct to ketamine for treatment-resistant depression (BA-KET). The BA-KET intervention will be administered over an 8-week period by an AHPRA approved psychologist or supervised provisional psychologist, There are a total of 8-10 therapy sessions, alongside the current 8-week standard ketamine treatment protocols used at study sites. There are three components to the manualised BA-KET therapy: 1. The Therapist Manual 2. The Patient Manual 3. The Patient Journal/Workbook Within the BA-KET manual there are 7 core tasks or aims, which utilise 9 worksheets. The core tasks and aims include: Task 1: Notice – Understanding My Depression • Aim 1: Learn how depression works and how the participant’s behaviour affects their mood. Task 2: Track – Monitoring My Daily Life • Aim 2: Build awareness of what helps or hurts the participants mood. Task 3: Explore – Identifying My Values • Aim 3: Reconnect with what really matters to the participant. Task 4: Plan – Turning Values into Action • Aim 4: Take small, realistic steps that build momentum. Task 5: Connect – Strengthening My Relationships • Aim 5: Rebuild safe, supportive connections. Task 6: Grow – Consolidating My Progress • Aim 6: Recognise what’s working and build confidence. Task 7: Maintain – Planning for the Future • Aim 7: Prepare for ups and downs with a plan that keeps the participant safe and steady after discharge. The Therapist Manual is designed to provide therapists with enough information to help conduct sessions and guide patients through the core tasks of BA-KET. The Patient Manual provides a more user-friendly guide for participants to use to help remind them of what they are aiming to do with each task. It is designed to reduce patient burden, while giving them enough information to be useful. The Patient Workbook/Journal has empty versions of the worksheets which can be photocopied and revisited as they work through the tasks under the guidance of their therapist. Core components as described in the Therapist Manual: • BATAK-D is designed as an 8–10 session program, delivered in parallel with repeat-dose ketamine treatment. Each session typically lasts 45–60 minutes, with flexibility to adapt to the patient’s needs and clinical setting. Sessions are structured, with clear goals and worksheets, but the therapist is encouraged to adjust pacing and emphasis depending on patient progress, energy, and engagement. The lived-experience co-design team felt flexibility in the delivery time and method would help reduce the barriers to completing BA. The only consensus was that therapy would not do well during ketamine treatments. Obviously, there will be limitations within your service model and according to therapist schedules, so this conversation is best had prior to beginning treatment, in collaboration with patients. The first session must be conducted prior to beginning ketamine treatment whenever possible. We recommend the first two sessions be completed prior to beginning ketamine treatment to ensure adequate time to complete a formulation and practice activity monitoring. • Subsequent sessions are usually scheduled weekly and when possible, coordinated with patient preferences around ketamine dosing days. • We recommend you wait at least 4 hours after ketamine dosing, before a BA session. • We also recommend you avoid BA sessions immediately before ketamine treatments, to reduce cognitive load or potential psychosocial stressors prior to treatment. At least an hour break is recommended to allow the patient to process information and ground themselves prior to dosing with ketamine. • Otherwise, BA sessions may be conducted at any time around ketamine treatments. • Sessions are suitable to be conducted in-person or via teleconference. The Therapy Roadmap (and worksheets), as described in the Therapist Manual: Step 1 – Orientation & Preparation o Learn how ketamine and Behavioural Activation work together. Meet your therapist, learn about your depression, and prepare your journal. o Worksheet 1: depression formulation Step 2 – Monitoring My Days o Record what you do and how you feel. No judgment — just noticing patterns. o Worksheet 2: Activity monitoring Step 3 – Understanding My Cycles o Spot when avoidance keeps you stuck and when small actions help. o Worksheet 3: Vicious Cycles Step 4 – Exploring My Values o Identify what really matters to you across work, health, relationships, hobbies, and daily life. o Worksheet 4: Life Areas and Values Step 5 – Planning Activities o Turn your values into small, achievable actions. o Worksheet 5: Activity List Step 6 – Strengthening Connection o Map your support network and plan safe, meaningful contact with others. o Worksheet 6: My Connection Map o Worksheet 7: My Connection Activities Step 7 – Consolidating Progress o Review what’s worked, celebrate small wins, notice early warning signs. Step 8 – Planning for the Future o Create your Relapse Prevention Plan and gather your ongoing supports. o Worksheet 8: Relapse Awareness Checklist o Worksheet 9: Relapse Prevention Plan TREATMENT ADHERENCE - will be montired using the Behavioural Activation for Depression Scale long form (BADS-LF). KETAMINE TREATMENTS - Ketamine treatments are being conducted as per the standard treatment protocols at each site. - Ketamine treatments are not the intervention being investigated, and thus ketamine treatment algorithms are not being standardised, but rather are being used as per naturalistic protocols. - The dose, treatment frequency, and route of administration varies at each site, including esketamine nasal spray, subcutaneous ketamine injection, and intravenous ketamine infusion. - an 8-week program of ketamine treatments will be used. - All treatments are administered in clinics and thus, treatment adherence is assessed by attendance to scheduled treatment sessions.