Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000077965
Ethics application status
Approved
Date submitted
19/09/2019
Date registered
30/01/2020
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting mental health in high-risk occupations: A feasibility study to promote psychological capital in medical students and junior doctors.
Scientific title
Promoting mental health in high-risk occupations: A feasibility study to promote psychological capital in medical students and junior doctors.
Secondary ID [1] 299356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 314510 0
anxiety 314511 0
stress 314512 0
Condition category
Condition code
Mental Health 312857 312857 0 0
Depression
Mental Health 312858 312858 0 0
Anxiety
Mental Health 312859 312859 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine the feasibility of a workshop-delivered intervention to boost PsyCap and reduce poor mental health among University of Tasmania medical students and RHH junior medical officers. Using a randomised trial, we will compare the PsyCap workshop with an active control condition (psychoeducation only) and the PsyCap workshop plus a “booster session” and test the following hypotheses:

Hypothesis 1: Intervention will increase PsyCap (resilience, optimism, self-efficacy, and hope) will reduce CF and psychological distress; and

Hypothesis 2: Increased PsyCap (resilience, optimism, self-efficacy, and hope) will reduce CF and psychological distress.

Hypothesis 3: The PsyCap + booster session group will maintain the positive effect of the intervention for longer.

Participants from all three groups will be invited to attend group-based workshops (20-25 participants per group). The intervention will be implemented through a single one-off 3.5 hour facilitated group-based workshop. Online surveys will assess medical students and JMOs in all three groups at baseline, at intervention completion, and at 6-month follow up. Any improvement in ProQoL, depression, and anxiety as a result of increased PsyCap will be expected at 6- and 12-months (H2). All three groups (PsyCap, PsyCap+booster, and control) will also be assessed at 12-month follow-up to examine the maintenance of effects (H3).

Psychological Capital Intervention (PCI)
The PCI model aims to: (1) be brief (e.g. 3-4 hours); (2) enhance all four dimensions of PsyCap; and (3) enhance overall PsyCap through integration of the underlying principles and developmental aspects of each of the four individual PsyCap resource. The PCI involves a series of exercises individuals complete within a facilitated group-based workshop format (approx. 20-25 participants). The exercises develop each individual component of PsyCap (hope, efficacy, resilience and optimism), along with more integrative, reflective exercises which incorporate the development of the individual component training into an understanding and operationalization of overall PsyCap. For instance, individuals are asked to consider a personally meaningful work (or study) related goal. In identifying this goal, the individual is assisted by the facilitator to phrase the goal to enhance ‘agentic capacity’ and to ‘step’ goals into manageable units. The individual is then guided to generate several pathways that could enable them to achieve this goal.
A critical element of the PCI delivery is facilitated small group discussions where individuals share their goals and pathways to generate additional pathways and model positive goal-setting behavior to the group. This group process enhances participants’ level of self-efficacy through the generation of additional pathways to achieve their stated goal/s; while also enhancing their positive expectations (optimism) to achieve it. The generation of multiple pathways for goal achievement also increases resilience by enabling participants to ‘bounce back’ by selecting an alternative pathway, if an original pathway is blocked or met with challenge.
The final element of the PCI focuses on optimism development by increasing participants’ awareness of negative cognitions they may possess when faced with a challenge at work. This element is based upon cognitive-behavioral theory which posits people tend to make automatic, unfounded, negative cognitions when confronted with problems, which generates negative behaviors (e.g. “This is hopeless, I can’t possibly complete this assignment by the deadline. I give up!”). The PCI optimism development phase aims to counter negative cognitive distortions by encouraging participants to identify, challenge and replace them with more positively-oriented, realistic expectations (e.g. “This assignment is going to take a lot of work, but I have done similar assignments before and can do this one if I keep working”). Psychoeducation materials are provided to all three groups. PsyCap and PsyCap+booster groups will receive these at the workshop. The control group will be email electronic versions of these materials at their nominated email address.

One of the groups that receive the PsyCap training workshop will also receive a 1.5-hour PsyCap booster session delivered 2 months following the initial workshop. This facilitated booster session will also be delivered in a group-based workshop format. The booster sessions are designed to provide an opportunity for participants to further develop the skills learned in the initial workshop and to tailor these skills to their own personal work/study-related goals and challenges. The PCI and booster sessions will be facilitated by trained educators/clinical psychologists who have extensive experience in workshop facilitation (Dr. Sarah Dawkins, Prof. Angela Martin) and will involve role-play, group discussion and exercises similar to the initial workshop.
Intervention code [1] 315623 0
Prevention
Comparator / control treatment
Active control group - psychoeducation material.

These materials are readily available resources from beyondblue relating to depression, anxiety, treatment options and recovery/staying, These will be sent to the participants in an email as links. They will also be sent a link to well a link to Health to Health - https://headtohealth.gov.au/?utm_source=mindhealthconnect&utm_medium=301
and beyondblue's "Get Support" page.

Participants in the control group will be offered the opportunity to attend a workshop after the PsyCap and PsyCap+booster groups have completed their 6-month follow up survey.
Control group
Active

Outcomes
Primary outcome [1] 321462 0
The Psychological Capital Questionnaire (PsyCap): A measure of PsyCap with 24 items. Each of the four components in PsyCap (hope, optimism, resilience, and self-efficacy) are measured by six items. The resulting score represents an individual's level of positive PsyCap.
Timepoint [1] 321462 0
Baseline, post-intervention, 6 month, 12 month

Post-intervention is the primary timepoint.
Secondary outcome [1] 375054 0
Secondary Outcome - Depression
- The Depression Anxiety Stress Scores (DASS) – Short form: This is a 21-item questionnaire designed to measure the negative emotional states of depression, anxiety and stress.
­- Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia.
­
Timepoint [1] 375054 0
baseline, post-intervention, 6 months post-baseline, 12 months post baseline
Secondary outcome [2] 378959 0
Secondary Outcome - Anxiety
- The Depression Anxiety Stress Scores (DASS) – Short form: This is a 21-item questionnaire designed to measure the negative emotional states of depression, anxiety and stress.
- Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect.
Timepoint [2] 378959 0
baseline, post-intervention, 6 month post-baseline, 12 month post-baseline
Secondary outcome [3] 378960 0
Secondary Outcome - Stress
- The Depression Anxiety Stress Scores (DASS) – Short form: This is a 21-item questionnaire designed to measure the negative emotional states of depression, anxiety and stress.
- Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient.
Timepoint [3] 378960 0
baseline, post-intervention, 6-month post-baseline, 12-month post-baseline

Eligibility
Key inclusion criteria
This feasibility trial will be open to all 4th and 5th year University of Tasmania medical students based at the University of Tasmania, Hobart Clinical School (approx. n=45) and all Junior Medical Officers – Interns (PGY1), Resident Medical Officers (PGY2, PGY3), and Registrars (PGY3, PGY4 or above) – based at the Royal Hobart Hospital (approx. n=285).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 15638 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 29047 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 303870 0
Commercial sector/Industry
Name [1] 303870 0
TasNetworks
Country [1] 303870 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
TasNetworks
Address
PO Box 606
MOONAH TAS 7009
Country
Australia
Secondary sponsor category [1] 304012 0
None
Name [1] 304012 0
Address [1] 304012 0
Country [1] 304012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304377 0
Tasmanian Health and Medical Human Research Ethics Committee (HMHREC)
Ethics committee address [1] 304377 0
301 Sandy Bay Road
Sandy Bay TAS 7005
Ethics committee country [1] 304377 0
Australia
Date submitted for ethics approval [1] 304377 0
16/09/2019
Approval date [1] 304377 0
17/10/2019
Ethics approval number [1] 304377 0

Summary
Brief summary
This study aims to evaluate the feasibility of an intervention program to reduce depression, anxiety, stress and compassion fatigue among medical students based at the University of Tasmania’s Hobart Clinical School and junior medical officers (JMOs) based at the Royal Hobart Hospital via the development of their psychological capital and promotion of their skills and capacities for coping with inevitable work-related stressors. Using a randomised trial, we will compare the PsyCap workshop with an active control condition (psychoeducation only) and the PsyCap workshop plus a “booster session” and test the following hypotheses:
Hypothesis 1: Increasing PsyCap (resilience, optimism, self-efficacy, and hope) will reduce CF and psychological distress; and
Hypothesis 2: The PsyCap + booster session group will maintain the positive effect of the intervention for longer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96746 0
Dr Fiona Cocker
Address 96746 0
University of Tasmania
School of Medicine
17 Liverpool Street, Hobart TAS 7001
Country 96746 0
Australia
Phone 96746 0
+61 0417333491
Fax 96746 0
Email 96746 0
[email protected]
Contact person for public queries
Name 96747 0
Dr Fiona Cocker
Address 96747 0
University of Tasmania
School of Medicine
17 Liverpool Street, Hobart TAS 7001
Country 96747 0
Australia
Phone 96747 0
+61 0417333491
Fax 96747 0
Email 96747 0
[email protected]
Contact person for scientific queries
Name 96748 0
Dr Fiona Cocker
Address 96748 0
University of Tasmania
School of Medicine
17 Liverpool Street, Hobart TAS 7001
Country 96748 0
Australia
Phone 96748 0
+61 0417333491
Fax 96748 0
Email 96748 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
This is a feasibility trial. Data from the larger future study will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4986Study protocol  [email protected] 378422-(Uploaded-20-01-2020-16-11-46)-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.