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Depression Return to Work Intervention (DRIVEN)

Primary Purpose

Job Stress, Distress, Emotional

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DRIVEN Application
Career Resources
Sponsored by
Inspiration at Work
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Job Stress focused on measuring depression, unemployment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Inspiration at Work, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Conventional Job-Search Program

DRIVEN App-Based Program

Arm Description

6 weeks of self-guided job-seeking

6 weeks of job-seeking guided by the DRIVEN curriculum

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2023
Last Updated
August 30, 2023
Sponsor
Inspiration at Work
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT06026280
Brief Title
Depression Return to Work Intervention
Acronym
DRIVEN
Official Title
Developing an App-based Behavioral Intervention to Help Depressed Individuals Return to Work
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspiration at Work
Collaborators
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Job Stress, Distress, Emotional
Keywords
depression, unemployment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Job-Search Program
Arm Type
Placebo Comparator
Arm Description
6 weeks of self-guided job-seeking
Arm Title
DRIVEN App-Based Program
Arm Type
Experimental
Arm Description
6 weeks of job-seeking guided by the DRIVEN curriculum
Intervention Type
Behavioral
Intervention Name(s)
DRIVEN Application
Intervention Description
Participants will complete the six-week DRIVEN program, which includes a smartphone application and job coaching.
Intervention Type
Other
Intervention Name(s)
Career Resources
Intervention Description
Participants will receive weekly information about job-searching skills and resources from a study coordinator for six weeks.
Primary Outcome Measure Information:
Title
Job Search Behavior (JSB) Scale
Description
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.
Time Frame
Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Secondary Outcome Measure Information:
Title
Job Search Self Efficacy (JSSE) Scale
Description
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.
Time Frame
Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
The Inventory of Depression and Anxiety Symptoms (IDAS) - Social Anxiety Subscale
Description
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.
Time Frame
Baseline; Week 3 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Patient Reported Outcome Measures Information System (PROMIS) Depression Scale
Description
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.
Time Frame
Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Patient Reported Outcome Measures Information System (PROMIS) Positive Affect Scale
Description
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.
Time Frame
Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Patient Reported Outcome Measures Information System (PROMIS) Meaning and Purpose Scale
Description
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.
Time Frame
Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Cognitive Behavioral Avoidance Scale (CBAS)
Description
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.
Time Frame
Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Behavioral Activation for Depression Scale (BADS)
Description
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.
Time Frame
Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Cognitive Flexibility Inventory (CFI)
Description
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.
Time Frame
Baseline; Week 5 of program; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
Participant Global Impression of Change (PGIC)
Description
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.
Time Frame
Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Title
System Usability Scale (SUS)
Description
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).
Time Frame
Week 1 of program; Week 6 of program
Title
Job Status Questionnaire
Description
Measure to assess whether or not someone obtained a job throughout the course of the study.
Time Frame
Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 or family history of mania or psychosis Currently employed, retired, or a full-time student
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mystie L. Saturday, BA
Phone
(872) 252-8260
Email
mystie.saturday@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra R. Levit
Organizational Affiliation
Inspiration at Work
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stewart A. Shankman, PhD
Organizational Affiliation
Northwestern University, Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James W. Griffith, PhD
Organizational Affiliation
Northwestern University, Department of Medical Social Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inspiration at Work, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Levit
Phone
773-349-2610
Email
arl@alexandralevit.com
First Name & Middle Initial & Last Name & Degree
Mystie L Saturday
Phone
‪(872) 252-8260‬
Email
mystie.saturday@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Depression Return to Work Intervention

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