Depression Return to Work Intervention (DRIVEN)

October 16, 2024 updated by: Inspiration at Work

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Inspiration at Work, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Job Search Behavior (JSB) Scale
Time Frame: 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.
Baseline; Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Job Search Self Efficacy (JSSE) Scale
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline; Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
Cognitive Behavioral Avoidance Scale (CBAS)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
Week 6 of program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)
System Usability Scale (SUS)
Time Frame: 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).
Week 1 of program; Week 6 of program
Job Status Questionnaire
Time Frame: 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.
Each week of the program; Follow-up (8 weeks after program); Follow-up (16 weeks after program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inspiration at Work

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R42MH127971 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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