Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001432404
Ethics application status
Approved
Date submitted
24/09/2016
Date registered
13/10/2016
Date last updated
23/04/2020
Date data sharing statement initially provided
23/04/2020
Date results information initially provided
23/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community Intervention for Promoting Psychological Well-Being among Unemployed
Scientific title
Development, implementation and evaluation of the impact of a mental health promotion intervention to build capacity and reduce inequalities for unemployed: A community controlled trial
Secondary ID [1] 290211 0
None
Universal Trial Number (UTN)
U1111-1187-2096
Trial acronym
Healthy Search for Employment - HSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 300380 0
Anxiety 300381 0
Addiction 300384 0
Condition category
Condition code
Mental Health 300245 300245 0 0
Depression
Mental Health 300247 300247 0 0
Anxiety
Mental Health 300248 300248 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy Search for Employment intervention focuses on the promotion of unemployed individuals’ social, emotional and interpersonal skills. It also targets the strengthening of resilience and the ability to overcome the adversity of unemployment. A strong focus will be given to mental health literacy strengthening. Health education sessions will be carried out by clinical psychologists with experience in prevention and treatment of depression and anxiety disorders (with more than five years of clinical practice). It is planned to be a short-term intervention adapted and delivered to groups. The intervention will be conducted on site (two public employment centres). The format, setting and contents of the intervention will be defined on basis of literature reviews and Delphi technique, assuring its adequacy as a short-term and sustainable community intervention. Still, the intervention is expected to include the following requirements:
- Modules: Mental health literacy (depression, anxiety, burnout, emotions), work-life balance, mental health related stigma (personal and perceived stigma), assertiveness training, definition of individual plans of action (defining short, medium and long term goals)
- Materials: a standardized operating procedure manual (with training and implementation material for facilitators); each participant will get a booklet with mental health literacy contents and exercises for psychosocial and interpersonal skills self-training.
- Procedures: roleplays, group discussion of vignettes, emotional and cognitive self-awareness individual tasks based on cognitive-behavioural intervention (e.g., ABC task for assessing emotions, behaviours and cognitions, Gallassi’s assertive behaviour grill, for assessing contexts of assertiveness-related difficulties, etc.
- Intervention providers: psychologists with at least 5 years of training
- Mode of delivery: face-to-face, to groups (8-12 participants)
- Number of sessions: 5 sessions, spread out into two- to three-weeks, 20 hours in total (four hours per session)
- Location: two public employment centres
Intervention assessment will follow the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework dimensions: reach, effectiveness, implementation and maintenance of qualities/properties.
The reach assessment will be evaluated by measuring the proportion of invited users from public employment centres that accepts to participate in the intervention. Effectiveness will be assessed through a randomized experimental field study with two arms (arm 1: intervention group ; arm 2: control group). Participants are unemployed people (18-65 years old, both genders, having at least nine years of formal education) registered at two public employment centres (from two different geographical regions) for less than 12 months, including first-job seekers. They will be recruited by intentional sampling and randomly allocated to arm 1 (intervention group) or arm 2 (control group) through a sequential match-to-case process, considering gender, age groups and educational level. The control group will receive the care-as-usual from public employment centres.
The implementation assessment will be done by evaluating the extent to which the syllabus and training intervention is adequate and accomplished across the intervention (fidelity assessment). A specific fidelity assessment form will be filled in by trainers and co-trainers (based on already existent toolkit forms). Also, trainees’ satisfaction with practical exercises will be assessed.
Finally, managers and supervisors’ willingness to replicate the intervention in other units of public employment centres will be assessed as a measure of the extent to which the intervention will be sustained over time (maintenance assessment).
Intervention code [1] 295975 0
Prevention
Intervention code [2] 296026 0
Lifestyle
Intervention code [3] 296027 0
Behaviour
Comparator / control treatment
As mentioned, the intervention will be assessed through a randomized field study with two arms (arm 1: intervention group and arm 2: control group). Users from two public employment centres will be recruited with intentional sampling and randomly allocated to arm 1 or arm 2 groups. The arm 2 group (control group) will receive the care-as-usual from public employment centres (targeting only skills for job search) which includes training and practicing of job seeking skills (e.g., writing a CV or a job application, personal image care, interviewing tips).
Control group
Active

Outcomes
Primary outcome [1] 299723 0
Mental health literacy, assessed by modified/shortened versions of (a) Depression Literacy Questionnaire (D-Lit) and (b) Anxiety Literacy Questionnaire (A-Lit), developed by Griffiths et al (2008).
Timepoint [1] 299723 0
Three moments of evaluation will occur: before intervention (baseline), immediately after its ending and three months later.
Primary outcome [2] 299724 0
Mental health-related personal and perceived stigma (composite primary outcome), assessed by a modified/shortened version of the Depression Stigma Scale (DSS), developed by Griffiths et al (2008).
Timepoint [2] 299724 0
Three moments of evaluation will occur: before intervention (baseline), immediately after its ending and three months later.
Secondary outcome [1] 327947 0
Psychological well-being, assessed by the Brief Symptom Inventory (BSI), developed by Derogatis (1983).
Timepoint [1] 327947 0
Three moments of evaluation will occur: before intervention (baseline), immediately after its ending and three months later.
Secondary outcome [2] 327948 0
Satisfaction with life, assessed by the Satisfaction with Life Scale (SWLS), developed by Diener (1985).
Timepoint [2] 327948 0
Three moments of evaluation will occur: before intervention (baseline), immediately after its ending and three months later.
Secondary outcome [3] 327949 0
Resilience, assessed by the Connor-Davidson Resilience Scale (CD-RISC) (2003).
Timepoint [3] 327949 0
Three moments of evaluation will occur: before intervention (baseline), immediately after its ending and three months later.

Eligibility
Key inclusion criteria
Unemployed people (18-65 years old, both genders, having at least nine years of formal education) registered at public employment centres from different geographical regions for less than 12 months (including first-job seekers).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Public employment centres’ unemployed users already attending, at the moment of the recruitment, other public employment centre’s courses.
Users with a diagnosed mental or physical severe disorder or disability.
Chronic but not disabling diseases, such as depression, anxiety disorder, diabetes or hypertension, are not exclusion criteria.

Study design
Purpose of the study
Prevention
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
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
Intention to treat analysis and per protocol analysis. Logistic regression analyses. Cohens' d and odds ratio for effect size estimation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
1/03/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
30/12/2016
Date of last data collection
Anticipated
30/04/2017
Actual
30/04/2017
Sample size
Target
100
Accrual to date
Final
127
Recruitment outside Australia
Country [1] 8255 0
Portugal
State/province [1] 8255 0
Loures and Sines

Funding & Sponsors
Funding source category [1] 294574 0
Other Collaborative groups
Name [1] 294574 0
European Economic Area (EEA) Grants (Public Health Initiatives Programme [PT06])
Country [1] 294574 0
Portugal
Primary sponsor type
University
Name
Faculdade de Medicina da Universidade de Lisboa
Address
Faculdade de Medicina da Universidade de Lisboa,
Av. Prof. Egas Moniz,
1649 – 028, Lisboa
Portugal
Country
Portugal
Secondary sponsor category [1] 293444 0
None
Name [1] 293444 0
Address [1] 293444 0
Country [1] 293444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296011 0
Comissao de Etica do Centro Academico de Medicina de Lisboa
Ethics committee address [1] 296011 0
Faculdade de Medicina da Universidade de Lisboa
Av. Professor Egas Moniz
1649-028 Lisboa
Ethics committee country [1] 296011 0
Portugal
Date submitted for ethics approval [1] 296011 0
07/04/2015
Approval date [1] 296011 0
20/04/2015
Ethics approval number [1] 296011 0
168/15

Summary
Brief summary
Background: Unemployment rates have increased exponentially over the last 10 years in Portugal. These vulnerable populations have an increased risk of suffering from mood and somatoform disorders (e.g., depression, anxiety), as well as alcohol or drug abuse. Economic recession has also been highlighted as a risk factor for suicide ideation, suicide attempts and death by suicide. In Portugal, there has been limited support to the needs of socio-economic vulnerable groups and there is lack of evidence-based large-scale mental health promotion programs. There is a need for effective programs involving different sectors of the society, such as primary healthcare services, and family and social welfare support structures.
Project goals: Main community intervention goals of the project are: (a) to develop and implement a structured and standardized mental health promotion program, preventing negative psychological effects of unemployment, and (b) to empower unemployed and temporary-working people, in order to enhance mental health resilience and efficacious job search skills. Main research goals are: (a) to review evidence about efficacy of mental health promotion programs targeted to unemployed populations and temporary workers, (b) to create consensus regarding strategies, methods and priority areas of intervention to promote mental health, and (c) to assess effectiveness of a mental health promotion program, developed in the context of this project.
Methods: This is a mental health promotion community-based intervention program for unemployed, aiming to enhance resilience and personal skills to overcome the adversity of job-related socio-economic conditions. Main beneficiaries of the program will be unemployed people registered at employment centers. A systematic literature review (PRISMA guidelines) and a Delphi panel (consensus-building technique) with experts will be carried for supporting key-elements to include in the intervention program (formalized in an operating procedures manual). The intervention will comprise: socio-cognitive/emotional training, time and stress management, unemployment stigma-related coping strategies, assertiveness training, self-efficacy promotion, inoculation against setbacks and empowerment for job search/reintegration. Participants will be recruited by intentional sampling and will be randomly allocated on study or control conditions. The control group will receive a work-promoters’ intervention as usual. The project evaluation will run parallel to the process of developing, implementing and sustaining the program, in order to provide an ongoing feedback the different actors involved. The overall project assessment will follow the REAIM framework (assessing reach, effectiveness, adoption, implementation and maintenance qualities/properties of the program), which will be used for monitoring and evaluating outcome achievement.
Trial website
www.empregosaudavel.org
Trial related presentations / publications
Virgolino, A., Heitor, M. J., Carreiras, J., Lopes, E., Øverland, S., Torp, S., et al. (2017). Facing unemployment: Study protocol for the implementation and evaluation of a community-based intervention for psychological well-being promotion. BMC Psychiatry, 17(1), 1–9.
Public notes

Contacts
Principal investigator
Name 68894 0
Dr Maria Joao Heitor dos Santos
Address 68894 0
Faculdade de Medicina da Universidade de Lisboa,
Av. Prof. Egas Moniz,
1649 – 028 Lisboa
Country 68894 0
Portugal
Phone 68894 0
+351 217985148
Fax 68894 0
Email 68894 0
[email protected]
Contact person for public queries
Name 68895 0
Dr Ana Patricia Lopes Virgolino
Address 68895 0
Faculdade de Medicina da Universidade de Lisboa,
Av. Prof. Egas Moniz,
1649 – 028 Lisboa
Country 68895 0
Portugal
Phone 68895 0
+351 217985148
Fax 68895 0
Email 68895 0
[email protected]
Contact person for scientific queries
Name 68896 0
Dr Ana Patricia Lopes Virgolino
Address 68896 0
Faculdade de Medicina da Universidade de Lisboa,
Av. Prof. Egas Moniz,
1649 – 028 Lisboa
Country 68896 0
Portugal
Phone 68896 0
+351 217985148
Fax 68896 0
Email 68896 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
7737Study protocolVirgolino A, Heitor MJ, Carreiras J, Lopes E, Øverland S, Torp S, Guðmundsdóttir D, Pereira Miguel J, Reis MF, Santos O. Facing unemployment: study protocol for the implementation and evaluation of a community-based intervention for psychological well-being promotion. BMC Psychiatry. 2017;17(1):261. doi: 10.1186/s12888-017-1416-xhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517795/pdf/12888_2017_Article_1416.pdf 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIFacing unemployment: study protocol for the implementation and evaluation of a community-based intervention for psychological well-being promotion2017https://doi.org/10.1186/s12888-017-1416-x
N.B. These documents automatically identified may not have been verified by the study sponsor.