Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001170617
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
13/11/2023
Date last updated
14/02/2024
Date data sharing statement initially provided
13/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural Activation Therapy for Mood Disorders in Aotearoa
Scientific title
The BeAT-MD Feasibility Trial: Behavioural Activation Therapy for Mood Disorders in Aotearoa
Secondary ID [1] 310820 0
Nil
Universal Trial Number (UTN)
Trial acronym
BeAT-MD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 331813 0
Bipolar disorder 331814 0
Condition category
Condition code
Mental Health 328558 328558 0 0
Depression
Mental Health 328559 328559 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327232 0
Treatment: Other
Intervention code [2] 327233 0
Treatment: Drugs
Comparator / control treatment
No control group - open label trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336366 0
Study feasibility
Timepoint [1] 336366 0
Treatment feasibility - 6 months post-baseline (treatment-end)

Treatment satisfaction - 6 months post-baseline (treatment-end)

Recruitment and retention - baseline, 6 months post-baseline, 12 months post-baseline
Primary outcome [2] 336367 0
Safety
Timepoint [2] 336367 0
3 months post-baseline and 6 months post-baseline
Secondary outcome [1] 428027 0
Experience of intervention (BeAT-MD)
Timepoint [1] 428027 0
6 months post-baseline
Secondary outcome [2] 428028 0
Mood burden
Timepoint [2] 428028 0
Baseline, 3 months post-baseline, 6 months post-baseline, 9 months post-baseline, 12 months post-baseline
Secondary outcome [3] 428029 0
Depression
Timepoint [3] 428029 0
Baseline, 3 months post-baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [4] 428030 0
Mania
Timepoint [4] 428030 0
Baseline, 3 months post-baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [5] 428031 0
Depression (self-report)
Timepoint [5] 428031 0
Baseline, 3 months post-baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [6] 428032 0
Medication adherence
Timepoint [6] 428032 0
Baseline, 3 months post-baseline, 6 months post-baseline, 9 months post-baseline, 12 months post-baseline
Secondary outcome [7] 428033 0
General functioning
Timepoint [7] 428033 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [8] 428034 0
Subjective cognitive functioning
Timepoint [8] 428034 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [9] 428035 0
Quality of life
Timepoint [9] 428035 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [10] 428036 0
Behavioural activation
Timepoint [10] 428036 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [11] 428050 0
Sleep rhythms
Timepoint [11] 428050 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [12] 428051 0
Rumination
Timepoint [12] 428051 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [13] 428053 0
Wellbeing and health
Timepoint [13] 428053 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [14] 428054 0
Objective cognitive function - global cognition
Timepoint [14] 428054 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [15] 428055 0
Objective cognitive function - verbal learning and memory
Timepoint [15] 428055 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [16] 428056 0
Objective cognitive function - visuospatial learning and memory
Timepoint [16] 428056 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [17] 428058 0
Objective cognitive function - executive function
Timepoint [17] 428058 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [18] 428060 0
Objective cognitive function - sustained attention
Timepoint [18] 428060 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [19] 428062 0
Objective cognitive function - psychomotor speed
Timepoint [19] 428062 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [20] 428063 0
Objective cognitive function - emotion processing
Timepoint [20] 428063 0
Baseline, 6 months post-baseline, 12 months post-baseline

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis of feasibility outcomes, as per above.
Effect size differences on quantitative outcomes between baseline and treatment-end (6 months), and baseline and study end (12 months).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
29/01/2024
Date of last participant enrolment
Anticipated
1/02/2026
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 25910 0
New Zealand
State/province [1] 25910 0
Canterbury

Funding & Sponsors
Funding source category [1] 315063 0
Charities/Societies/Foundations
Name [1] 315063 0
Canterbury Medical Research Foundation
Country [1] 315063 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317089 0
None
Name [1] 317089 0
Address [1] 317089 0
Country [1] 317089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314015 0
New Zealand Health and Disability Ethics Committee (Central)
Ethics committee address [1] 314015 0
Ethics committee country [1] 314015 0
New Zealand
Date submitted for ethics approval [1] 314015 0
03/08/2023
Approval date [1] 314015 0
06/10/2023
Ethics approval number [1] 314015 0
2023 EXP 18439

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130126 0
A/Prof Katie Douglas
Address 130126 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 130126 0
New Zealand
Phone 130126 0
+64 3 3726739
Fax 130126 0
Email 130126 0
katie.douglas@otago.ac.nz
Contact person for public queries
Name 130127 0
Katie Douglas
Address 130127 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 130127 0
New Zealand
Phone 130127 0
+64 3 3726739
Fax 130127 0
Email 130127 0
katie.douglas@otago.ac.nz
Contact person for scientific queries
Name 130128 0
Katie Douglas
Address 130128 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch
Country 130128 0
New Zealand
Phone 130128 0
+64 3 3726739
Fax 130128 0
Email 130128 0
katie.douglas@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data individual participant data underlying published results only.
When will data be available (start and end dates)?
Following publication; no end-date determined
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal and meta-analysis
How or where can data be obtained?
By email approach to the principal investigator on katie.douglas@otago.ac.nz


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.