Clinical trial NCT06026280: Depression Return to Work Intervention
Official title: Developing an App-based Behavioral Intervention to Help Depressed Individuals Return to Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Job Stress
Distress, Emotional
Keywords: depression
unemployment
Lead sponsor: Inspiration at Work
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2023-09-07
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Job Search Behavior (JSB) Scale
timeFrame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary outcomes:
measure: Job Search Self Efficacy (JSSE) Scale
timeFrame: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: The Inventory of Depression and Anxiety Symptoms (IDAS) - Social Anxiety Subscale
timeFrame: Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Patient Reported Outcome Measures Information System (PROMIS) Depression Scale
timeFrame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Patient Reported Outcome Measures Information System (PROMIS) Positive Affect Scale
timeFrame: Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Patient Reported Outcome Measures Information System (PROMIS) Meaning and Purpose Scale
timeFrame: Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Cognitive Behavioral Avoidance Scale (CBAS)
timeFrame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Cognitive Flexibility Inventory (CFI)
timeFrame: Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: Participant Global Impression of Change (PGIC)
timeFrame: Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
measure: System Usability Scale (SUS)
timeFrame: Week 1 of program; Week 6 of program
measure: Job Status Questionnaire
timeFrame: Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Inspiration at Work, Inc.
state: Illinois
Study officials:
affiliation: Inspiration at Work
name: Alexandra R. Levit
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University, Department of Psychiatry and Behavioral Sciences
name: Stewart A. Shankman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: James W. Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
References: