AzTrials
AzTrials

Job StressDRIVENNCT06026280

Depression Return to Work Intervention

A study testing DRIVEN Application and Career Resources in people with Job Stress and Distress, Emotional, run by Inspiration at Work at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized controlled trial to test the effectiveness of a mobile app-based program aimed to help individuals with unemployment-related emotional distress return to work. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Job Stress, Distress, Emotional
What is being tested?
DRIVEN Application and Career Resources
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
141 participants
Where
1 siteUnited States
Study dates
7 Aug 2023to 28 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18-65 years of age
  • Currently unemployed and actively searching for work
  • Prior to unemployment, were employed full-time (35 hours per week or more) for at least 1 year
  • Prior to unemployment, received an individual highest salary of $100,000 or less
  • Owns an iPhone or Android Phone
  • Willing and able to provide informed consent
  • Has a minimum depression score according to the PROMIS depression scale
  • Able to communicate in English (verbal and written)

Who cannot join

  • Current moderate or severe alcohol/substance use disorders
  • Current symptoms of mania or psychosis
  • Currently employed, retired, or a full or part-time student

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inspiration at Work, Inc.

    Chicago, Illinois, 60614

Other trials in United States

About this study

Official title: Developing an App-based Behavioral Intervention to Help Depressed Individuals Return to Work

This study is a randomized controlled trial to test the effectiveness of a mobile app-based program aimed to help individuals with unemployment-related emotional distress return to work.

Read the detailed description

This study will compare two different approaches to reducing unemployment-related emotional distress. Participants will be involved in the study for a total of 22 weeks. During the first 6 weeks, participants will complete activities relating to either the mobile-app based program or the self-guided job-seeking program. The study team will follow up with participants at 8 weeks after the program is completed and at 16 weeks after the program is completed. Participants will also be asked to complete questionnaires before starting the program, during the program, after they complete the program, and at the follow-up visits. The questionnaires will be about the participant's mood, job seeking behavior, and related emotional experiences.

Being tested
DRIVEN Application, Career Resources
Keywords
depression, unemployment
Medical subject headings
Occupational Stress, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DRIVEN ApplicationBehavioural

    Participants will complete the six-week DRIVEN program, which includes a smartphone application and job coaching.

  • Career ResourcesOther

    Participants will receive weekly information about job-searching skills and resources from a study coordinator for six weeks.

Study groups in NCT06026280
Study groupRoleWhat they receive
Conventional Job-Search ProgramPlacebo comparator6 weeks of self-guided job-seeking
Receives: Other: Career Resources
DRIVEN App-Based ProgramExperimental6 weeks of job-seeking guided by the DRIVEN curriculum
Receives: Behavioral: DRIVEN Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Job Search Behavior (JSB) Scale

    10-item scale to assess the frequency that a person performs certain job seeking behaviors within a week. Each item has 5 answer options (from 0 times to 6 or more times). A higher score indicates that someone performs more job seeking behaviors each week.

    Measured: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

Secondary outcomes (11)

  1. Job Search Self Efficacy (JSSE) Scale

    20-item scale to assess someone's confidence in performing job seeking behaviors and achieving job seeking outcomes. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are averaged to produce a final domain score between 1 and 5. A higher score indicates that someone is more confident in performing a job seeking behavior or achieving a job seeking outcome, depending on the domain.

    Measured: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  2. The Inventory of Depression and Anxiety Symptoms (IDAS) - Social Anxiety Subscale

    6-item scale to assess social anxiety symptoms. Each item has 5 answer options (from 1 to 5). A higher score indicates a greater presence of that symptom within the past two weeks.

    Measured: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  3. Patient Reported Outcome Measures Information System (PROMIS) Depression Scale

    8-item scale to assess depression. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater presence of depressive symptoms.

    Measured: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  4. Patient Reported Outcome Measures Information System (PROMIS) Positive Affect Scale

    15-item scale to assess positive affect. Each item has 5 answer options (from 1 to 5). Minimum score = 15; maximum score = 75. A higher score indicates a greater presence of positive affect.

    Measured: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  5. Patient Reported Outcome Measures Information System (PROMIS) Meaning and Purpose Scale

    8-item scale to assess meaning and purpose in someone's life. Each item has 5 answer options (from 1 to 5). Minimum score = 8; maximum score = 40. A higher score indicates a greater sense of meaning and purpose.

    Measured: Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  6. Cognitive Behavioral Avoidance Scale (CBAS)

    31-item scale to assess what strategies someone uses to deal with situations and problems, with strategies falling into the domains of behavioral-social, cognitive-nonsocial, cognitive-social, and behavioral-nonsocial. Each item has 5 answer options (from 1 to 5). Raw scores of items from each domain are summed to produce a final domain score. A higher score indicates a greater presence of that coping strategy in someone's life.

    Measured: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  7. Behavioral Activation for Depression Scale (BADS)

    9-item scale to assess behavioral activation. Each item has 7 answer options (from 0 to 6). Minimum score = 0; maximum score = 54. A higher score indicates higher activation.

    Measured: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  8. Cognitive Flexibility Inventory (CFI)

    20-item scale to assess cognitive flexibility. Each item has 7 answer options (from 1 to 7). Minimum score = 20; maximum score = 140. A higher score indicates more cognitive flexibility.

    Measured: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  9. Participant Global Impression of Change (PGIC)

    To assess participant's impression of change in their depression since the start of the intervention. This scale is 1-item. Minimum score = 1; maximum score = 5. A higher score indicates the best change since starting the intervention.

    Measured: Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

  10. System Usability Scale (SUS)

    10-item measure to assess the usability of the program. Each item has 5 answer options (from 1 to 5). Minimum raw score = 0; maximum raw score = 40. Raw scores are multiplied by 2.5 to give a final score of 0 (representing the worst usability) to 100 (representing the best usability).

    Measured: Week 1 of program; Week 6 of program

  11. Job Status Questionnaire

    Measure to assess whether or not someone obtained a job throughout the course of the study.

    Measured: Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start7 Aug 2023
  3. Primary completion28 Sep 2024
  4. Study completion28 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06026280
Sponsor's protocol ID
R42MH127971
Acronym
DRIVEN
Status last verified
Oct 2024
First submitted
30 Aug 2023
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Danielson EC, Saturday M, Leonard S, Levit A, Graham AK, Marquez M, Alperin K, Shankman SA, Griffith JW. Efficacy of a Mobile App-Based Behavioral Intervention (DRIVEN) to Help Individuals With Unemployment-Related Emotional Distress Return to Work: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 26;13:e62715. doi: 10.2196/62715.

    PubMed 39589786

Questions about this trial

What is this clinical trial studying?

A study testing DRIVEN Application and Career Resources in people with Job Stress and Distress, Emotional, run by Inspiration at Work at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Job Search Behavior (JSB) Scale (time frame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06026280, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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