Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000894897p
Ethics application status
Submitted, not yet approved
Date submitted
21/05/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based Intensive Activation Therapy for Major Depression
Scientific title
Feasibility and Efficacy of Community-based Intensive Activation Therapy for Major Depression
Secondary ID [1] 304277 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Depression 322005 0
Condition category
Condition code
Mental Health 319725 319725 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is evaluating the feasibility of delivering therapy to people currently being treated for Major Depressive Disorder by their general practitioners. They will be randomised to receive either Intensive Activation Therapy or Patient-centred Psychoeducation – a supportive educational therapy. Intensive Activation Therapy is a combination of Behavioural Activation and Cognitive Remediation which has been designed for this study. Sessions will be delivered in person or via videoconference and will be delivered twice a week for four weeks and then weekly for another four weeks, with some flexibility in timing (allowing a total therapy time of 10 weeks). Sessions last between 30 and 40 minutes. The intervention is delivered by nurses and psychologists. Fidelity to treatment model will be monitored by the supervising psychologist with regular supervision sessions. Therapy tracking forms will contain date, session number, level of engagement, therapy focus and duration of session.
Intervention code [1] 320616 0
Behaviour
Intervention code [2] 320924 0
Treatment: Other
Comparator / control treatment
Patient-centred Psychoeducation (PDP) is a supportive educational control therapy. It will be delivered one-to-one either in-person or via teleconferencing platform. It is a manualised therapy designed for use in a previous feasibility study. It involves supportive therapy and education about triggers, early warning signs and management strategies. Patients will receive 5 sessions of 30-40 minutes over 8 weeks of PDP. PDP uses online and hard copy psychoeducational resources combined with 5 psychoeducational sessions with a therapist. The education resources have been designed for this study. The intervention is delivered by nurses and psychologists. Fidelity to treatment model will be monitored by the supervising psychologist with regular supervision sessions. Therapy tracking forms will contain date, session number, level of engagement, therapy focus and duration of session.
Control group
Active

Outcomes
Primary outcome [1] 327592 0
Ability to recruit 40 participants and deliver therapy over 2 years.
This will be assessed using an audit of the study database and therapy tracking forms.
Timepoint [1] 327592 0
24 months from commencement of recruitment process.
Primary outcome [2] 328199 0
Acceptability of the process of recruitment, assessment and therapy to Maori and non-MaoriData will be collected on the numbers who engage in >75% of sessions, those that drop out and the reasons for drop out. Data will be collected on participant preferences for in-person or tele-conference delivery and reasons. Qualitative interviews will be conducted with all participants on completion of the intervention to evaluate their perceptions of effectiveness, accessibility of the intervention, and its general acceptability as an intervention.
Timepoint [2] 328199 0
24 months
Primary outcome [3] 328200 0
Completion of adequate dose of therapy
Number of, and content of therapy sessions will be recorded and doses of therapy calculated from this.
Timepoint [3] 328200 0
24 months
Secondary outcome [1] 395825 0
Depressive symptoms measured using Quick Inventory of Depressive Symptoms - Self-Report.
Timepoint [1] 395825 0
8 weeks from commencement of intervention.
Secondary outcome [2] 397997 0
Ability to manage risk in a community setting
Brief risk assessments will be conducted in each session and crisis plans developed with each patient, including directions regarding contacting family or doctors. Therapists may also recommend that patients seek a medication review with their GP if this is deemed necessary. At recruitment, patients will provide details of contacts for GPs and/or private psychiatrists and a letter from the medical practitioner acknowledging that the patient is participating in the study but that they will continue to provide usual care. The feasibility study will assess the practicality of these arrangements and their acceptability for primary care clinicians.
Timepoint [2] 397997 0
24 months
Secondary outcome [3] 397998 0
Training of therapists and ability to maintain treatment fidelity. Intervention and control treatments will be delivered according to a manualised protocol. Some sessions will be recorded to assess the degree to which the therapist employs techniques appropriate to both interventions.
Timepoint [3] 397998 0
24 months

Eligibility
Key inclusion criteria
Primary diagnosis of major depressive episode
Under GP care
Able to participate in weekly sessions in person or via zoom
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Major Depressive Disorder. (MDD) not the primary diagnosis, (ii) unable to provide informed consent, (iii) unable to participate in a 8-10-week psychotherapy (iii) cognitive impairment from organic causes. Patients in remote centres will only be able to participate if they have a computer and workable internet access

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)
Patients will receive sealed opaque envelopes with their randomisation allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No statistical methods in feasibility study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
Date of last participant enrolment
Anticipated
29/07/2023
Actual
Date of last data collection
Anticipated
29/07/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 23717 0
New Zealand
State/province [1] 23717 0
Canterbury

Funding & Sponsors
Funding source category [1] 308654 0
Government body
Name [1] 308654 0
NZ Health Research Council
Country [1] 308654 0
New Zealand
Primary sponsor type
University
Name
UNiversity of Otago
Address
PO Box 4345 Christchurch NZ 8011
Country
New Zealand
Secondary sponsor category [1] 309531 0
None
Name [1] 309531 0
Nil
Address [1] 309531 0
Nil
Country [1] 309531 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308580 0
NZ Health and Disability Ethics Committee-Expedited Review pathway.
Ethics committee address [1] 308580 0
Ethics committee country [1] 308580 0
New Zealand
Date submitted for ethics approval [1] 308580 0
21/05/2021
Approval date [1] 308580 0
Ethics approval number [1] 308580 0

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

Contacts
Principal investigator
Name 111214 0
Prof Marie Crowe
Address 111214 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
NZ 8011
Country 111214 0
New Zealand
Phone 111214 0
+64 3 3726700
Fax 111214 0
Email 111214 0
marie.crowe@otago.ac.nz
Contact person for public queries
Name 111215 0
Marie Crowe
Address 111215 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
NZ 8011
Country 111215 0
New Zealand
Phone 111215 0
+64 3 3726700
Fax 111215 0
Email 111215 0
marie.crowe@otago.ac.nz
Contact person for scientific queries
Name 111216 0
Marie Crowe
Address 111216 0
Dept of Psychological Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch
NZ 8011
Country 111216 0
New Zealand
Phone 111216 0
+64 3 3726700
Fax 111216 0
Email 111216 0
marie.crowe@otago.ac.nz

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


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.