Depression Return to Work Intervention

Distress, Emotional Clinical Trial

— DRIVEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026280
• Other study ID #: R42MH127971
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: September 19, 2024

Study information

• Verified date: April 2024
• Source: Inspiration at Work
• Contact: Mystie L. Saturday, BA
• Phone: (872) 252-8260
• Email: mystie.saturday[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 19, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional
• Job Stress
• Occupational Stress

Intervention

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

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

Locations

Country	Name	City	State
United States	Inspiration at Work, Inc.	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Inspiration at Work	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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.	Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary	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).	Week 1 of program; Week 6 of program
Secondary	Job Status Questionnaire	Measure to assess whether or not someone obtained a job throughout the course of the study.	Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)