Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000907943p
Ethics application status
Submitted, not yet approved
Date submitted
21/07/2020
Date registered
14/09/2020
Date last updated
14/09/2020
Date data sharing statement initially provided
14/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Tele-therapy for recurrent mood disorders
Scientific title
Evaluating the feasibility of tele-therapy for recurrent mood disorders
Secondary ID [1] 301834 0
N/A
Universal Trial Number (UTN)
U1111-1255-7871
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Mood disorders 318317 0
Major depressive disorder 318609 0
Bipolar Disorder 318610 0
Condition category
Condition code
Mental Health 316326 316326 0 0
Depression
Mental Health 316629 316629 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Patients will receive tele-therapy. Either 20 x 1 hour sessions of Interpersonal and Social Rhythm Therapy (IPSRT) initially weekly and then two-weekly or monthly over 30 weeks; or 5 one-hour sessions of Patient-centred Psychoeducation for Depression (PPD) over 30 weeks. Both therapies will be delivered on to one via teleconference. There are four therapists (3 nurses and one social worker) who have been trained in IPSRT and with experience of its delivery in research conditions ranging from 2 - 15 years. PPD is a newly developed therapy which follows a manualised protocol and has been designed as an equivalent to good case management in community mental health services. This has been designed specifically for this study. In addition to face to face sessions, patients will receive their own resource book. PPD will be delivered by 3 nurses with extensive experience in caring for patients with mood disorders. All therapists will attend two-weekly supervision to ensure fidelity to the treatment. We have effective processes to ensure fidelity for in-person delivery but need to evaluate whether these can be maintained via tele-conferencing. The feasibility study will, therefore, need to assess the fidelity to both therapies by evaluating recordings of the sessions.
Intervention code [1] 318128 0
Treatment: Other
Comparator / control treatment
Control treatment: Patients will receive 5 x 1 hour sessions over 30 weeks (frequency to be negotiated with the patient but anticipated to be 4-6 weekly) of Patient-directed Psychoeducation for Mood Disorders (PPMD). The goals of PPMD which is an educational rather than psychological intervention like IPSRT are: The goals of PCP are to:
• Provide knowledge of depression (MDD and BD)
• Identify triggers and early warning signs
This is a manual developed specifically for this study.
• Explore strategies for healthy living
• Develop a relapse plan
PPMD provides information about publicly available online psychoeducational resources and a resource book that covers understanding your mood, knowing what to do, healthy lifestyle, and relapse prevention. Participants are provided with questions to consider between sessions and then at each face to face session, the therapist provides the patient with a 15-minute didactic session and an opportunity to discuss what this means for them. Patients are able to choose what aspects of the broad topics they wish to discuss. This is markedly different from IPSRT which is a structured psychological intervention consisting of interpersonal psychotherapy and social rhythm therapy.on the topic of that particular session.. PPMD replicates what most patients would receive from good case management within specialist community mental health services.
Control group
Active

Outcomes
Primary outcome [1] 324494 0
Acceptability of the tele-health mode of delivery for patients and therapists: Tele-IPSRT will be delivered for 20 sessions and tele-PDP for five sessions via Zoom. We will record the number of potential patients who are unable to participate because of lack of access to a computer and internet connection. Semi-structured qualitative interviews will be conducted at follow-up with both therapists and patients to identify the acceptability of this mode of delivery. The number of drop-outs and reasons for drop-out will also be used to indicate acceptability
Timepoint [1] 324494 0
At completion of study intervention anticipated to be up until Sept 2022
Secondary outcome [1] 384810 0
Acceptability of the intervention and mode of delivery for Maori: We hope to recruit five Maori patients and the therapy team includes one Maori therapist (with plans to train further Maori). We will seek feedback from Maori patients and therapists on cultural acceptability of the intervention and the need for any modifications. Data will be collected via one-on-one audio-recorded qualitative interviews.
Timepoint [1] 384810 0
At completion of study intervention anticipated to be up until Sept 2022
Secondary outcome [2] 385741 0
Ability to recruit sufficient patients in a timely manner and engage patients in both interventions for a full dose of treatment: We aim to recruit 20 patients who have previously received treatment from mental health services in Christchurch and 5 in Timaru. Patients will consent to be randomised to either tele-IPSRT or tele-PDP. (200 patients for the full study would require estimated recruitment over 3 years as follows: Christchurch 60, Wellington 60, Dunedin 30, Timaru 15, Nelson 15, West Coast 10, Hawkes Bay 10. Feasibility will, therefore, be supported if in one year we are able to recruit 5 patients from Timaru and 20 from Christchurch). We will record the number of sessions patients complete and the number who complete 75% (adequate dose) of sessions in both the intervention and control arms.
Timepoint [2] 385741 0
At the end of recruitment anticipated to be September 2021
Secondary outcome [3] 385742 0
Ability to maintain treatment fidelity with tele-therapy delivery: 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. At follow-up, patients will complete modified versions of the Psychotherapy Practice Scale (Miranda J, Hepner KA, Azocar F, Greenwood G, Ngo V, Burnam MA. Development of a patient-report measure of psychotherapy for depression. Adm Policy Ment Health. 2010;37(3):245-53) , to examine what techniques they perceived the therapist as using. Greater than 80% fidelity for the interventions will be considered feasible.
Timepoint [3] 385742 0
At conclusion of intervention anticipated to be before Sept 2022
Secondary outcome [4] 385743 0
Ability to manage risk with tele-mental health mode of delivery: 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 [4] 385743 0
This will be assessed at the end of the intervention anticipated to be Sept 2022

Eligibility
Key inclusion criteria
Inclusion criteria: diagnosis of MDD or BD; recent treatment and discharge from specialist mental health services (within 3 months); access to a computer with camera; reliable internet connectivity.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: severe substance abuse disorder; unable to speak sufficient English for psychotherapy; schizophrenia or schizoaffective disorder; and having completed a course of IPSRT in past 18 months.

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)
Participants will receive sealed opaque envelopes with their randomisation outcome
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 the feasibility study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 22777 0
New Zealand
State/province [1] 22777 0
Christchurch

Funding & Sponsors
Funding source category [1] 306259 0
Government body
Name [1] 306259 0
Health Research Council
Country [1] 306259 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345 Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 306747 0
None
Name [1] 306747 0
Address [1] 306747 0
Country [1] 306747 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306467 0
Southern Health and Disability Ethics Committee, NZ
Ethics committee address [1] 306467 0
Ethics committee country [1] 306467 0
New Zealand
Date submitted for ethics approval [1] 306467 0
31/07/2020
Approval date [1] 306467 0
Ethics approval number [1] 306467 0

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

Contacts
Principal investigator
Name 103990 0
Prof Marie Crowe
Address 103990 0
Dept of Psychological Medicine
University of Otago,
PO Box 4345
Christchurch, NZ 8011
Country 103990 0
New Zealand
Phone 103990 0
+64 3 3726700
Fax 103990 0
+64 3 3720405
Email 103990 0
[email protected]
Contact person for public queries
Name 103991 0
Marie Crowe
Address 103991 0
Dept of Psychological Medicine
University of Otago,
PO Box 4345
Christchurch, NZ 8011
Country 103991 0
New Zealand
Phone 103991 0
+64 3 3726700
Fax 103991 0
+64 3 3720405
Email 103991 0
[email protected]
Contact person for scientific queries
Name 103992 0
Marie Crowe
Address 103992 0
Dept of Psychological Medicine
University of Otago,
PO Box 4345
Christchurch, NZ 8011
Country 103992 0
New Zealand
Phone 103992 0
+64 3 3726700
Fax 103992 0
+64 3 3720405
Email 103992 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8551Ethical approval  [email protected]
8552Informed consent form  [email protected] 380233-(Uploaded-17-08-2020-12-20-14)-Study-related document.docx



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.