Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000024347
Ethics application status
Approved
Date submitted
22/12/2016
Date registered
9/01/2017
Date last updated
31/05/2024
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Activation Therapy for the Treatment of Inpatient Depression
Scientific title
Randomised controlled trial of Activation Therapy versus Treatment As Usual for the treatment of cognitive impairment in inpatients admitted with depression
Secondary ID [1] 290756 0
Nil known
Universal Trial Number (UTN)
U1111-1190-9517
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301346 0
Condition category
Condition code
Mental Health 301105 301105 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 x 30-40 minute therapist sessions of Activation Therapy on-site at the psychiatric unit (4/week) and 10 x online practise sessions over 2 weeks (5/week) in addition to Treatment as Usual (see comparator treatment).

Activation Therapy consists of two components. Cognitive Activation and Behavioural Activation.

Cognitive Activation is the use of therapist guided computerised cognitive exercises from a programme called Scientific Brain Training Pro (https://www.scientificbraintrainingpro.com/ - provided free of charge for this study). These exercises are designed to activate parts of the brain that are under-active with depression. This system has been selected based on its use of tasks with flexibility to alter level of difficulty to meet the individual’s current functioning, ease of use and delivery in an attractive interactive format. Therapists will select cognitive tasks suitable for the patient’s current level of functioning from a menu of tasks, and in later sessions, review progress. Collaborative practice, encouragement and coaching will take place. Therapists will be experienced registered nurses, social workers, or psychologists familiar with the requirements of ward environments and working within multi-disciplinary teams. Patients will be encouraged to practise the exercises in-between therapy sessions to reinforce and build on learning occurring during therapy. Patients will focus on the exercises used in therapy when doing the on-line practise sessions.

Behavioural Activation occurs alongside the Cognitive Activation in the therapy led sessions. Behavioural Activation involves identification of both positive and negative reinforcers maintaining depressive symptoms and behaviours, and of reinforcers that promote more adaptive behaviours (i.e. those that re-engage the depressed person with previously rewarding or potentially rewarding aspects across the important domains of life). Personal values are identified and activities focussed on those values are considered. A graded hierarchy of pleasurable activities and activities that give the patient a sense of competency is then chosen and worked through collaboratively with the patient. Collaborative problem-solving of difficulties in undertaking the tasks occurs.

Training/adherence
Activation Therapy will be delivered according to our Activation Therapy manual by mental health professionals trained and closely supervised with a focus on adherence and competence.
Fidelity checklists of core strategies delivered during each sesson will be completed by therapists after each session to ensure all elements are delivered.
A random selection of 10% of audiotaped sessions will be listened to by a supervisor and scored according to the Quality of Behavioral Activation Scale.
Participant adherence will be measured by the 9-item Short Form Behavioral Activation Scale (BADS-SF) completed by participants at baseline, session 4 and session 8.
A single question self-rating the extent of practice of Behavioural Activation activities within the past 24 hours will be completed by participants at each session. The frequency and duration of on-line cognitive activation exercises will also be monitored through the Scientific Brain Training Pro programme.
Intervention code [1] 296661 0
Treatment: Other
Comparator / control treatment
Treatment as Usual involves nursing care, regular review with medical staff, pharmacotherapy, and an occupational therapist led therapeutic programme including diversional group activities (walks and therapeutic activities e.g., cooking). Availability of psychology input is limited due to resourcing factors and usually only occurs in cases in which the admission has become prolonged and would therefore occur after the end of the treatment period. Treatment as Usual is provided for the study period (2 weeks) and then continues for patients in the comparator and intervention groups until discharge.
Control group
Active

Outcomes
Primary outcome [1] 306908 0
Rates of hospital re-admission within 12 weeks of discharge – these will be determined from the patient’s electronic record and it is therefore very unlikely that there will be any missing data for this outcome.
Timepoint [1] 306908 0
12 weeks following discharhge
Primary outcome [2] 306909 0
Rates of hospital re-admission within 12 weeks of discharge – these will be determined from the patient’s electronic record and it is therefore very unlikely that there will be any missing data for this outcome.
Timepoint [2] 306909 0
12 weeks following discharge
Secondary outcome [1] 330171 0
Change in the Functioning Assessment Short Test will be used to assess functioning
Timepoint [1] 330171 0
14 weeks after baseline assessment
Secondary outcome [2] 330172 0
The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-rated depression severity scale which will be used to assess depression severity.
Timepoint [2] 330172 0
2 weeks, 8 weeks, and 14 weeks following baseline assessment
Secondary outcome [3] 330173 0
Readmission to hospital with a primary diagnosis of depression will be assessed by a review of medical records
Timepoint [3] 330173 0
within 1 year following baseline assessment
Secondary outcome [4] 330174 0
Total days spent in hospital will be assessed by a review of medical records
Timepoint [4] 330174 0
within 1 year following baseline assessment
Secondary outcome [5] 350065 0
Change in a composite cognitive score generated by adding z scores of the change between baseline and follow-up for a pre-selected group of cognitive measures. These measures cover the domains of visual and verbal memory and learning, attention, executive function, and psychomotor function. The composite score measures are comprised from the following variables: Brief Visuospatial Memory Test, Rey Auditory-Verbal Learning Task- total words recalled in all learning trials, Rey Auditory-Verbal Learning Task - words recalled delayed recall, Category Fluency- total words generated, Category Fluency Switching - total correct switches, Digit Span - total forwards plus backwards, Trail Making Test part A and B, Stroop Test, Symbol Coding (BACS). The composite score will be calculated by computing z scores for each variable (score/standard deviation of the score at baseline). The z score for each variable will be added and divided by the number of variables to create a composite z score. z scores at baseline and at follow-up will be entered into general linear model.
Timepoint [5] 350065 0
14 weeks

Eligibility
Key inclusion criteria
Individuals admitted to the participating psychiatric inpatient units with a primary diagnosis of depression, who are computer literate and able to complete questionnaires and therapy in English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of schizophrenia
Current severe alcohol or drug use disorder
Comorbid serious endocrinological, neurological or chronic medical condition
Pregnancy
Previous severe head injury
Electro-convulsive therapy (ECT) in the past six months or ECT planned for the current admission

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur after consent and baseline measures. Randomisation will be undertaken by the research nurse accessing a password protected on-line system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block, stratified by mood disorder diagnosis (bipolar vs unipolar) and by treatment unit (te Awakura in-patient unit vs Te ao Marama in patient unit)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome will be analysed by Cochrane Mantel-Haenszel Test, stratified by site and mood disorder diagnosis. The analysis population will be intention-to-treat.

The 12 week re-admission rate between 2013 and 2015 (prior to the start of the feasibility study) was 40%. We propose that a clinically significant reduction in this rate would be to 20%. To have 80% power to show such a difference between groups as statistically significant (p<0.05) will require 82 patients per group.

The power calculation for the secondary outcome of composite cognitive measure will be as follows. In an equivalent group of patients with depression, the difference in mean z-scores between patients and healthy controls on the composite cognitive measure at follow-up was 0.8. We can therefore assume a similar difference in the TAU group. A clinically meaningful difference would be to reduce this by half - to a difference after treatment of 0.4 in the AT group. The SD of change of the composite z-score in the equivalent group was 0.7. We are therefore aiming for a difference in change in z-score compared with controls of 0.4 with an SD of 0.7. Sixty five patients per group will give 90% power to detect this difference as statistically significant (2-tailed a=0.05).

This secondary outcome will be analysed by general linear mixed model with group and site as between-subject factors and time (baseline/follow-up) as a within-subjects factor. Analysis population will be intention-to-treat with all patients who are randomised entered into the analysis. This will be regardless of protocol (treatment adherence). Patients who do not undergo repeat cognitive testing will be assumed not to have changed. Close liaison with patients and their clinicians following discharge and an interim contact to carry out mood rating, plus testing in patients’ homes will maximise follow-up and minimise the chance of differential dropout between groups.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
4/02/2019
Date of last participant enrolment
Anticipated
2/07/2023
Actual
27/07/2023
Date of last data collection
Anticipated
27/07/2024
Actual
Sample size
Target
170
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 8505 0
New Zealand
State/province [1] 8505 0
Canterbury, South Canterbury

Funding & Sponsors
Funding source category [1] 300264 0
Charities/Societies/Foundations
Name [1] 300264 0
Canterbury Medical Research Foundation
Country [1] 300264 0
New Zealand
Funding source category [2] 309981 0
Government body
Name [2] 309981 0
New Zealand Health Research Council
Country [2] 309981 0
New Zealand
Primary sponsor type
Individual
Name
Professor Richard Porter
Address
Terrace House
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 294013 0
None
Name [1] 294013 0
None
Address [1] 294013 0
None
Country [1] 294013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296537 0
Health and Disabilities Ethics Committees (Northern B Health and Disability Ethics Committee
Ethics committee address [1] 296537 0
Ethics committee country [1] 296537 0
New Zealand
Date submitted for ethics approval [1] 296537 0
09/04/2018
Approval date [1] 296537 0
01/06/2018
Ethics approval number [1] 296537 0
18/NTB/75

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

Contacts
Principal investigator
Name 71186 0
Prof Richard Porter
Address 71186 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 71186 0
New Zealand
Phone 71186 0
+64 3 3726700
Fax 71186 0
+64 3 3726707
Email 71186 0
[email protected]
Contact person for public queries
Name 71187 0
Richard Porter
Address 71187 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 71187 0
New Zealand
Phone 71187 0
+64 3 3726700
Fax 71187 0
+64 3 3726707
Email 71187 0
[email protected]
Contact person for scientific queries
Name 71188 0
Richard Porter
Address 71188 0
Department of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Mail Centre
Christchurch 8140
Country 71188 0
New Zealand
Phone 71188 0
+64 3 3726700
Fax 71188 0
+64 3 3726707
Email 71188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseActivation therapy for the treatment of inpatients with depression - Protocol for a randomised control trial compared to treatment as usual.2019https://dx.doi.org/10.1186/s12888-019-2038-2
N.B. These documents automatically identified may not have been verified by the study sponsor.