None listed
Conditions
Brief summary
Combining medication and psychological therapy is recommended for long-term recovery for mood disorders in New Zealand, but most people with mood disorders cannot access psychological intervention, resulting in high rates of readmission. Maori, in particular, are less likely to be referred for psychological therapy, indicating poor implementation of best practice. There is an urgent need for effectively delivered, culturally responsive psychological treatments to reduce the impact of mood disorders for people in New Zealand. This will be an open-label feasibility trial of Behavioural Activation Therapy for Mood Disorders (BeAT-MD), an intervention we have adapted to incorporate unique features of bipolar disorder (e.g., high and low mood states, sleep disruption) and Maori models of health. Forty people with mood disorders will be recruited soon after discharge from mental health services (Te Whatu Ora Waitaha). They will receive BeAT-MD for 6 months (up to 20 sessions), and complete pre- and post-treatment assessments of mood and functioning, as well as an interview about their treatment experience. Feasibility, acceptability and change in research measure scores will inform a larger-scale trial of BeAT-MD.
Interventions
Behavioural Activation Therapy for Mood Disorders (BeAT-MD) BeAT-MD will be delivered according to the Behavioural Activation manual by Martell et al. (Martell et al. Behavioural Activation for Depression: A Clinician's Guide, 2nd edn. New York: The Guilford Press; 2022), The manual has been adapted for the NZ context using therapeutic activities from He Puna Whakaata (McLachlan et al. He Puna Whakaata: Therapeutic Activities to Guide Change II. Wellington: Te Rau Ora; 2019.). Behavioural Activation seeks to re-establish healthy patterns of activity and replace behaviours that function to avoid or manage distress with more adaptive, value-based behaviours that are rewarding or constructive in the longer-term. BeAT-MD includes adaptations from the Martell et al. manual to address the unique clinical features of bipolar disorder (as per: Wright et al: Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. Brain Sci. 2022; 12).. This includes consideration of the person’s relationship to medication. To address concerns about (hypo)manic relapse, we have included contracting work with the individual at an early stage about how symptoms of hypomania/mania would be noticed and responded to within therapy. We have also used the framework of functional analysis to explore mood-driven behaviour prompted by positive, angry or energised states rather than only by negative feelings. Session content: 1) assessment phase (sessions 1-4): psychological assessment using a behavioural activation framework, feedback of psychological formulation, psychoeducation, values assessment, goat setting; 2) middle phase (sessions approx. 5-16): self-monitoring of mood, activities and sleep; activity scheduling using graded task assignment; avoidance modification; and extra modules focused on rumination, problem solving, communication, negotiating support, and managing high mood states; 3) end phase (sessions approx. 17-20): relapse prevention. Mode of training: this is a behavioural psychological intervention (talking therapy), in which a therapist will help the patient learn strategies to improve/stabilise mood. Patients will be provided with a workbook with information about Behavioural Activation, information about mood disorders, and forms required for monitoring mood and scheduling activities throughout therapy. Participants will be offered up to 20 face-to-face individual BeAT-MD sessions over 6 months (Zoom therapy for the occasional session may be used if the patient is physically unwell). Each session will be between 45 minutes to 1 hour. Sessions will be delivered 2x weekly for the first 2 weeks, then weekly for 10 weeks (up to 3 months), then fortnightly to monthly for the second 3 months. Dosing in the final 3 months will be based on progress in treatment and participant preference. A total of 18-20 sessions will be considered a full therapy dose, and 13 sessions (75%) an adequate dose, as per our previous trials. Therapists will be mental health nurse, psychologists or other mental health clinicians. Therapists will be trained in BeAT-MD by study investigators (clinical psychologists) with extensive experience in delivering Behavioural Activation Therapy (A/Prof Jenny Jordan, A/Prof Katie Douglas). Therapy sessions will be audio-taped and 10% will be randomly selected to ensure adherence to therapy protocol using a quality criteria instrument developed for Behavioural Activation. Therapists will participate in fortnightly group supervision, led by A/Prof Jenny Jordan. BeAT-MD will be delivered at the Clinical Research Unit, Department of Psychological Medicine, University of Otago, Christchurch, New Zealand. This is a joint university and health service (Te Whatu Ora: Health New Zealand) for outpatients. MEDICATION MANAGEMENT One of six psychiatrists will provide medication management to all participants in this trial. Participants will be accepted into the trial on any medication regimen, and psychiatrists will use clinical judgement and the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (Malhi et al. The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Aust N Z J Psychiatry. 2021; 55:7-117) to inform medication management decisions. The treating psychiatrist will see participants (face-to-face, individual format) on study entry, and at 3 and 6 months, as well as when requested by the participant’s therapist or the participant. Each medication management session will take between 30-60 minutes. Medication adherence is monitored through the use of the Medication Adherence Report Scale (MARS), conducted at baseline, 3 months, 6 months, 9 months, and 12 months.
Sponsors
Study design
Eligibility
Inclusion criteria
- Individuals with Major Depressive Disorder or Bipolar Disorder - Within 3 months of discharge from specialist mental health services in Canterbury (Te Whatu Ora Waitaha). - Aged between 18-65 years.
Exclusion criteria
Current severe substance use disorder Schizophrenia or schizoaffective disorder Neurodegenerative disease (e.g., dementia) History of severe brain injury (loss of consciousness for >1h) Intellectual disability Pregnancy Having had a course of Behavioural Activation Therapy in the last 18 months Actively engaged in another psychotherapy concurrently Unable to communicate in English