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Completed

NCT Number: NCT06026280

Depression Return to Work Intervention

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inspiration at Work, Inc.

Chicago, Illinois, 60614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

DRIVEN Application

Behavioral

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

Career Resources

Other

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Job Search Self Efficacy (JSSE) Scale

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  6. Cognitive Behavioral Avoidance Scale (CBAS)

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

    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.

  7. Behavioral Activation for Depression Scale (BADS)

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

    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.

  8. Cognitive Flexibility Inventory (CFI)

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

    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.

  9. Participant Global Impression of Change (PGIC)

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

    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.

  10. System Usability Scale (SUS)

    Time frame: Week 1 of program; Week 6 of program

    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).

  11. Job Status Questionnaire

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

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

Sponsors and collaborators

Lead sponsor

Inspiration at Work

Industry

Collaborators

  • Northwestern University

Registry information

Official study title

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

Acronym: DRIVEN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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