DRIVEN: Depression Return to Work Intervention

Sponsor
Inspiration at Work (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06026280
Collaborator
Northwestern University (Other)
120
1
2
13.4
8.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DRIVEN Application
  • Other: Career Resources
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Developing an App-based Behavioral Intervention to Help Depressed Individuals Return to Work
Actual Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Conventional Job-Search Program

6 weeks of self-guided job-seeking

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

Experimental: DRIVEN App-Based Program

6 weeks of job-seeking guided by the DRIVEN curriculum

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

Outcome Measures

Primary Outcome Measures

  1. Job Search Behavior (JSB) Scale [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 Outcome Measures

  1. Job Search Self Efficacy (JSSE) Scale [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 [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 [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 [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 [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) [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) [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) [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) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 or family history of mania or psychosis

  • Currently employed, retired, or a full-time student

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inspiration at Work, Inc. Chicago Illinois United States 60614

Sponsors and Collaborators

  • Inspiration at Work
  • Northwestern University

Investigators

  • Principal Investigator: Alexandra R. Levit, Inspiration at Work
  • Principal Investigator: Stewart A. Shankman, PhD, Northwestern University, Department of Psychiatry and Behavioral Sciences
  • Principal Investigator: James W. Griffith, PhD, Northwestern University, Department of Medical Social Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inspiration at Work
ClinicalTrials.gov Identifier:
NCT06026280
Other Study ID Numbers:
  • R42MH127971
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Inspiration at Work
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023