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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

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]

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

Anxiety

Addiction

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]