Depression Return to Work Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Job Stress, Distress, Emotional

Intervention / Treatment
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* Behavioral: DRIVEN Application
* Other: Career Resources


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional Job-Search Program<br>6 weeks of self-guided job-seeking | Other: Career Resources<br>* Participants will receive weekly information about job-searching skills and resources from a study coordinator for six weeks.<br>|
| Experimental: DRIVEN App-Based Program<br>6 weeks of job-seeking guided by the DRIVEN curriculum | Behavioral: DRIVEN Application<br>* Participants will complete the six-week DRIVEN program, which includes a smartphone application and job coaching.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, unemployment