Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000854831
Ethics application status
Approved
Date submitted
5/07/2012
Date registered
14/08/2012
Date last updated
14/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of Problem-solving versus Cognitive restructuring Of Medically Ill Seniors with depression (PROMISE-D trial)
Scientific title
A randomized controlled trial of the effect on depression of Problem-solving versus Cognitive restructuring Of Medically Ill Seniors with depression (PROMISE-D trial)
Secondary ID [1] 280784 0
Nil
Universal Trial Number (UTN)
U1111-1132-4599
Trial acronym
PROMISE-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Illness in the context of one or more medical illnesses 286844 0
Condition category
Condition code
Mental Health 287163 287163 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem-solving therapy: Participants are taught problem solving strategies for dealing with illness and other stress related problems. 10 x 1 hour weekly individual sessions

Cognitive Therapy: Participants are introduced to the role of thoughts in emotions, learn to recognise and challenge unhelpful beliefs and construct behavioural experiments to test out their concerns. 10, 1 hour weekly individual sessions
Intervention code [1] 285213 0
Treatment: Other
Comparator / control treatment
Enhanced treatment as usual (Following the pre to post treatment phase, GPs will be informed if participants in the control condition continue to experience an affective disorder)
Control group
Active

Outcomes
Primary outcome [1] 287464 0
Diagnosis of depression (PRIME-MD)
Timepoint [1] 287464 0
Pre-treatment
Mid-treatment at 5 weeks
Post-treatment
6 month follow-up
12 month follow-up
Primary outcome [2] 287549 0
Severity of depression (Hamilton Depression Rating Scale)
Timepoint [2] 287549 0
Pre-treatment
Post-treatment
6 month follow-up
12 month follow-up
Primary outcome [3] 287550 0
Depressive symptoms (Geriatric Depression Scale)
Timepoint [3] 287550 0
Pre-treatment
Post-treatment
6 month follow-up
12 month follow-up
Secondary outcome [1] 298216 0
Quality of life (SF-36)
Timepoint [1] 298216 0
Pre-treatment
Post-treatment
6 month follow-up
12 month follow-up
Secondary outcome [2] 298367 0
Anxiety (Beck Anxiety Inventory)
Timepoint [2] 298367 0
Pre-treatment
Post-treatment
6 month follow-up
12 month follow-up
Secondary outcome [3] 298765 0
Health Care Utilization
Timepoint [3] 298765 0
At two year follow-up

Eligibility
Key inclusion criteria
(1) diagnosis of major or minor depressive disorder or dysthymia;
(2) if taking anti-depressant medication, a stable dose for > 8 weeks;
(3) have not received electroconvulsive therapy within 6 mths (to exclude memory problems) and
(4) sufficient English.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) suicidal intent requiring immediate treatment;
(2) alcohol or drug abuse or dependence;
(3) a history of bipolar disorder or cyclothymia;
(3) a psychotic illness;
(4) cognitive deficits (< 24 on the Mini-Mental State Examination); or
(5) have received psychotherapy within six 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 over 65 presenting to primary care services will be asked to complete a mood screener (GDS). Those who screen as having "possible depression" will be telephoned and the diagnostic interview given over the telephone. Those who have a diagnosable disorder will be consented into the trial by the assessor. The assessor will contact an independent research assistant (yet to be appointed), who is not involved in the assessment of participants, will then allocate the participant to conditions. These will be concealed in opaque envelopes (or equivalent) prior to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be determined using randomizer.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single-blind, randomized controlled trial of two psychological therapies in comparison to an enhanced treatment as usual control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
177
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285579 0
Charities/Societies/Foundations
Name [1] 285579 0
BeyondBlue
Country [1] 285579 0
Australia
Primary sponsor type
Individual
Name
Louise Sharpe
Address
School of Psychology
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 284489 0
University
Name [1] 284489 0
The University of Sydney
Address [1] 284489 0
School of Psychology
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country [1] 284489 0
Australia
Other collaborator category [1] 276911 0
Individual
Name [1] 276911 0
Pat Arean
Address [1] 276911 0
Department of Psychology, University of California in San Francisco, 401 Parnassus Ave, San Francisco, CA 94143
Country [1] 276911 0
United States of America
Other collaborator category [2] 276912 0
Individual
Name [2] 276912 0
Tanya Covic
Address [2] 276912 0
School of Social Sciences and Psychology, University of Western Sydney, Locked Bag 1797, Penrith NSW 2751
Country [2] 276912 0
Australia
Other collaborator category [3] 276913 0
Individual
Name [3] 276913 0
Helen Correia
Address [3] 276913 0
School of Psychology
South Street
Murdoch
Western Australia 6150
Country [3] 276913 0
Australia
Other collaborator category [4] 276914 0
Individual
Name [4] 276914 0
Michael Nicholas
Address [4] 276914 0
Pain Management and Research Centre
The University of Sydney
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country [4] 276914 0
Australia
Other collaborator category [5] 277018 0
Individual
Name [5] 277018 0
Pat Raue
Address [5] 277018 0
Weill Cornell Medical College
21 Bloomingdale Road
White Plains, NY 10605
Country [5] 277018 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287588 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287588 0
Jane Foss Russell Building
The University of Sydney
NSW 2006
Ethics committee country [1] 287588 0
Australia
Date submitted for ethics approval [1] 287588 0
14/06/2012
Approval date [1] 287588 0
Ethics approval number [1] 287588 0
Ref. No. 15027

Summary
Brief summary
The proposed study is a randomized controlled trial of two evidence-based treatments for late-life depression for patients who also have at least one co-morbid health problem. Participants will be randomised to two active interventions (ie PST or CBT) or treatment as usual (TAU). Randomization will be stratified by diagnosis: major depressive episode or minor depression/dysthymia, using computer-generated random numbers. All assessments will be completed by a researcher that remains blind to the allocation throughout the study. Participants will be assessed, using a range of questionnaire measures and a diagnostic interview, at pre and post-treatment, 6, and 12 months follow-up.
Trial website
N/a
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 34397 0
Address 34397 0
Country 34397 0
Phone 34397 0
Fax 34397 0
Email 34397 0
Contact person for public queries
Name 17644 0
Catherine Gittins
Address 17644 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 17644 0
Australia
Phone 17644 0
+61 2 93514558
Fax 17644 0
Email 17644 0
[email protected]
Contact person for scientific queries
Name 8572 0
Louise Sharpe
Address 8572 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 8572 0
Australia
Phone 8572 0
61 2 93514558
Fax 8572 0
61 2 9351 7328
Email 8572 0
[email protected]

No information has been provided regarding IPD availability


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.