Psychiatric DisorderNCT03409991
Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities
A study testing Opening Doors in people with Psychiatric Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This project is designed to develop and test a career guidance intervention called Opening Doors (OD) expected to assist individuals with psychiatric disabilities acquire knowledge, skills, and attitudes needed to pursue and advance in their careers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Opening Doors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2015to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18 years or older;
- have a psychiatric disability as evidenced by a) the presence of a psychiatric diagnosis, b) the interference of psychiatric symptoms with important areas of life functioning such as, work or school, and c) current or past use of psychiatric services such as, medications, hospitalizations, psychotherapy, etc.;
- express an interest in exploring their career options;
- are unemployed or engaged in part-time employment;
- express an interest in working in the future;
- have basic knowledge of using computers; and,
- are willing and able to attend a 1-2 hour orientation session at the Recovery Center.
Who cannot join
- are unable to give full and knowing consent;
- are unable to participate in data collection;
- are actively receiving vocational counseling; and, 4) have full-time paid employment;
- 5) have a legal guardian.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Center for Psychiatric Rehabilitation
Boston, Massachusetts, 02215
About this study
This project is designed to develop and test a career guidance intervention called Opening Doors (OD) expected to assist individuals with psychiatric disabilities acquire knowledge, skills, and attitudes needed to pursue and advance in their careers. This project is a three-stage mixed methods study to 1) refine and pilot-test the Opening Doors career guidance intervention, 2) conduct a randomized control trial (RCT) to test the efficacy of the intervention with a waitlist control group, and 3) conduct a qualitative and process sub-study of the critical ingredients of the OD intervention from the perspective of participants. This study takes place at the Boston University Center for Psychiatric Rehabilitation (CPR). It is hypothesized that when compared to control group participants, individuals receiving Opening Doors will report 1) higher levels of vocational and pre-vocational activities, 2) greater career adaptability, fewer dysfunctional and more functional career thoughts, 3) greater work hope when compared to the waitlist control group participants, 4) greater vocational goal attainment, and 5) improved symptoms and functioning.
Read the detailed description
This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention called Opening Doors to improve the employability and employment trajectory of individuals with psychiatric disabilities.
Stage 1 involved a pilot-test of the Opening Doors (OD) career guidance intervention to conduct a feasibility test. In Stage 2 the investigators are conducting a randomized control trial (RCT) to test the efficacy of the intervention. Stage 3, which is a qualitative and process sub-study to understand the value of the OD intervention from the perspective of participants, is being conducted simultaneously with Stage 2 The Opening Doors Intervention: The Opening Doors intervention is a new career guidance intervention for individuals with psychiatric disabilities that uses traditional career guidance resources, progressive employment principles and mainstream Internet-based resources, delivered in the context of providing tailored supports for participants' with mental illness. Opening Doors is designed as an approximately 12- week group and individual career guidance intervention. The curriculum is delivered by trained career counselors in small groups over about 20 sessions of 90 minutes each with the addition of up to 8 weekly 1 hour individual sessions. Opening Doors also has optional on-going drop-in hours available for participants of the program (current and past) to improve their job application potential on an on-going basis. Opening Doors includes considerable peer involvement i.e. the consultation and inclusion of individuals with lived experience of psychiatric disabilities in the development and delivery of the intervention.
Method: The Opening Doors intervention has been pilot-tested using a simple pretest-posttest design in order to assess feasibility of the intervention and research procedures. The investigators are currently using a randomized clinical trial design (RCT) to test the effectiveness of the Opening Doors intervention. Up to 108 participants are expected to participate in the intervention. Baseline assessments are completed and random assignment to experimental or control conditions are performed, stratifying for gender and minority status using a computer generated randomization plan. Assessments are conducted at baseline, 3, 6, 9 and 12 months post-baseline for both experimental and control groups. Control participants are placed on a waitlist and offered participation at a later date i.e. 12 months after the baseline assessment. The investigators use qualitative methods for a sub-study and process evaluation. Twelve participants (2 per wave) who have completed at least 12 sessions of the OD will be invited to participate in one-hour qualitative interviews to obtain their perspectives on the intervention. Each participant participates in a one hour single-session audio-taped interview by research staff. Data from the qualitative interviews is collected using an interview guide and participants are probed for perceived benefits of the intervention and hypothesized helpful mechanisms of OD. The investigators also query the staff about their perceptions of the barriers and facilitators to delivering OD. Additional process information described above in "process data" is collected on all study participants.
Data Analysis: Depending on the level of measurement, analysis of variance, t-tests, or chi-square tests were conducted to determine baseline equivalency between Experimental and Control groups. All hypotheses were tested using mixed modeling analyses, adjusting for baseline values and examining effects for time, group, and the group-by-time interactions. We found no differences between the experimental and control groups using an ITT approach or adjusting for intervention intensity. We conducted responder analyses to further explore what worked and for whom.
- Conditions
- Psychiatric Disorder
- Being tested
- Opening Doors
- Keywords
- Psychiatric Rehabilitation, Career Counseling
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opening DoorsBehavioural
This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention for individuals with psychiatric disabilities. We are using both a randomized clinical trial design coupled with a small qualitative sub-study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Receives the 12-week Opening Doors group sessions, and up to 8 individual career counseling sessions. Receives: Behavioral: Opening Doors |
| Waitlist Control | No intervention | Offered non-vocational classes at the Boston University Center for Psychiatric Rehabilitation, and offered the chance to attend the Opening Doors program at the end of their enrolled 12-month study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment and Vocational Activities Checklist
Participants will report greater engagement in vocational activities. Employment and Vocational Activities Checklist, a brief instrument used in prior Center studies that inquires about current pre-employment and vocational activities, including for example, career development activities and independent job searches
Measured: 12 months
Work Hope Scale (Juntunen & Wettersten, 2006)
24-item 7-point Likert-type scale that measures the construct of work hope, and includes: Work Goals, Agency, and Pathways. The scale is a stable and well-validated measure with reported internal consistency of the overall scale of .93 and .87, .68 and .81 for the sub-scales
Measured: 12 months
Goal Attainment Scale (GAS, Kiresuk, et al, 1968)
Goal Attainment Scale provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal (Kiresuk \& Sherman, 1968). Recent reviews of GAS confirms that it can be useful in measuring rehabilitation goals, is reliable and sensitive to change (Marson, et al., 2009; Hurn, et al., 2006, Turner-Stokes, 2009)
Measured: 12 months
Career Adapt-Abilities Scale (CAAS; Savickas & Porfeli, 2012)
Career Adapt-Abilities Scale (CAAS; Savickas \& Porfeli, 2012) measures an individual's psychosocial readiness and resources for coping with current and imminent vocational development tasks, occupational transitions, and work traumas using four scales which measure concern, control, curiosity, and confidence. Internal consistency estimates for the subscale and total scores ranged from good to excellent i.e. .82 to .88. Concurrent validity evidence was found to be strong between the subscales of CAAS and the Vocational Identity Status Assessment (VISA; Porfeli, Lee, Vondracek, \& Weigold, 2011)
Measured: 12 months
Career Thoughts Inventory (CTI; Sampson et al., 1996)
The CTI consists of 48 Likert-scale items rated on a 4-point agree scale representing typical dysfunctional/negative career thoughts including Decision-Making Confusion, Commitment Anxiety, and External Conflict. The CTI developers report alpha coefficients for the total score ranging from .93 to .97; and for the subscales ranged from .74 to .94. The authors also provide support for the CTI's construct validity, convergent validity, and criterion validity.
Measured: 12 months
Behavior and Symptom Identification Scale (BASIS - 24) (Eisen, et al., 2004, Eisen et al., 2006)
The BASIS-24 is designed to measure mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use using a 5-point Likert-type scale. Extensive and excellent reliability and validity data exists for the instrument from a national study involving over 5,000 participants (Eisen, et al., 2004; Eisen, et al., 2006)
Measured: 12 months
Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988)
Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988) measures both objective and subjective quality of life across multiple domains including living situation, family relations, social relations, work, and the like. It has considerable psychometric data suggesting adequate validity and reliability (Lehman, 1995; Russo et al., 1997). We will employ 2 items from this scale: the subjective measures of life in general and work satisfaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start24 Sep 2015
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Erna Sally Rogers, Boston University Charles River Campus
- Investigators
- Erna S. Rogers, Sc.D., Principal investigator, Boston University Center for Psychiatric Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409991
- Sponsor's protocol ID
- 3727
- Status last verified
- Sep 2021
- First submitted
- 18 Jan 2018
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT03409991
- Acronym / sponsor ID
- 3727
- Conditions
- Psychiatric Disorder
- Keywords
- Psychiatric Rehabilitation, Career Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 24 Sep 2015 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to develop and test a career guidance intervention called Opening Doors (OD) expected to assist individuals with psychiatric disabilities acquire knowledge, skills, and attitudes needed to pursue and advance in their careers. This project is a three-stage mixed methods study to 1) refine and pilot-test the Opening Doors career guidance intervention, 2) conduct a randomized control trial (RCT) to test the efficacy of the intervention with a waitlist control group, and 3) conduct a qualitative and process sub-study of the critical ingredients of the OD intervention from the perspective of participants. This study takes place at the Boston University Center for Psychiatric Rehabilitation (CPR). It is hypothesized that when compared to control group participants, individuals receiving Opening Doors will report 1) higher levels of vocational and pre-vocational activities, 2) greater career adaptability, fewer dysfunctional and more functional career thoughts, 3) greater work hope when compared to the waitlist control group participants, 4) greater vocational goal attainment, and 5) improved symptoms and functioning.
Detailed description
This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention called Opening Doors to improve the employability and employment trajectory of individuals with psychiatric disabilities.
Stage 1 involved a pilot-test of the Opening Doors (OD) career guidance intervention to conduct a feasibility test. In Stage 2 the investigators are conducting a randomized control trial (RCT) to test the efficacy of the intervention. Stage 3, which is a qualitative and process sub-study to understand the value of the OD intervention from the perspective of participants, is being conducted simultaneously with Stage 2 The Opening Doors Intervention: The Opening Doors intervention is a new career guidance intervention for individuals with psychiatric disabilities that uses traditional career guidance resources, progressive employment principles and mainstream Internet-based resources, delivered in the context of providing tailored supports for participants' with mental illness. Opening Doors is designed as an approximately 12- week group and individual career guidance intervention. The curriculum is delivered by trained career counselors in small groups over about 20 sessions of 90 minutes each with the addition of up to 8 weekly 1 hour individual sessions. Opening Doors also has optional on-going drop-in hours available for participants of the program (current and past) to improve their job application potential on an on-going basis. Opening Doors includes considerable peer involvement i.e. the consultation and inclusion of individuals with lived experience of psychiatric disabilities in the development and delivery of the intervention.
Method: The Opening Doors intervention has been pilot-tested using a simple pretest-posttest design in order to assess feasibility of the intervention and research procedures. The investigators are currently using a randomized clinical trial design (RCT) to test the effectiveness of the Opening Doors intervention. Up to 108 participants are expected to participate in the intervention. Baseline assessments are completed and random assignment to experimental or control conditions are performed, stratifying for gender and minority status using a computer generated randomization plan. Assessments are conducted at baseline, 3, 6, 9 and 12 months post-baseline for both experimental and control groups. Control participants are placed on a waitlist and offered participation at a later date i.e. 12 months after the baseline assessment. The investigators use qualitative methods for a sub-study and process evaluation. Twelve participants (2 per wave) who have completed at least 12 sessions of the OD will be invited to participate in one-hour qualitative interviews to obtain their perspectives on the intervention. Each participant participates in a one hour single-session audio-taped interview by research staff. Data from the qualitative interviews is collected using an interview guide and participants are probed for perceived benefits of the intervention and hypothesized helpful mechanisms of OD. The investigators also query the staff about their perceptions of the barriers and facilitators to delivering OD. Additional process information described above in "process data" is collected on all study participants.
Data Analysis: Depending on the level of measurement, analysis of variance, t-tests, or chi-square tests were conducted to determine baseline equivalency between Experimental and Control groups. All hypotheses were tested using mixed modeling analyses, adjusting for baseline values and examining effects for time, group, and the group-by-time interactions. We found no differences between the experimental and control groups using an ITT approach or adjusting for intervention intensity. We conducted responder analyses to further explore what worked and for whom.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Opening DoorsReceives the 12-week Opening Doors group sessions, and up to 8 individual career counseling sessions. |
| Waitlist Control | No intervention | –Offered non-vocational classes at the Boston University Center for Psychiatric Rehabilitation, and offered the chance to attend the Opening Doors program at the end of their enrolled 12-month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are 18 years or older;
- have a psychiatric disability as evidenced by a) the presence of a psychiatric diagnosis, b) the interference of psychiatric symptoms with important areas of life functioning such as, work or school, and c) current or past use of psychiatric services such as, medications, hospitalizations, psychotherapy, etc.;
- express an interest in exploring their career options;
- are unemployed or engaged in part-time employment;
- express an interest in working in the future;
Key exclusion criteria (4 listed)
- are unable to give full and knowing consent;
- are unable to participate in data collection;
- are actively receiving vocational counseling; and, 4) have full-time paid employment;
- 5) have a legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opening DoorsThis project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention for individuals with psychiatric disabilities. We are using both a randomized clinical trial design coupled with a small qualitative sub-study. | Behavioural | Experimental |
Primary outcome
Employment and Vocational Activities Checklist
Time frame: 12 months
Participants will report greater engagement in vocational activities. Employment and Vocational Activities Checklist, a brief instrument used in prior Center studies that inquires about current pre-employment and vocational activities, including for example, career development activities and independent job searches
Work Hope Scale (Juntunen & Wettersten, 2006)
Time frame: 12 months
24-item 7-point Likert-type scale that measures the construct of work hope, and includes: Work Goals, Agency, and Pathways. The scale is a stable and well-validated measure with reported internal consistency of the overall scale of .93 and .87, .68 and .81 for the sub-scales
Goal Attainment Scale (GAS, Kiresuk, et al, 1968)
Time frame: 12 months
Goal Attainment Scale provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal (Kiresuk \& Sherman, 1968). Recent reviews of GAS confirms that it can be useful in measuring rehabilitation goals, is reliable and sensitive to change (Marson, et al., 2009; Hurn, et al., 2006, Turner-Stokes, 2009)
Career Adapt-Abilities Scale (CAAS; Savickas & Porfeli, 2012)
Time frame: 12 months
Career Adapt-Abilities Scale (CAAS; Savickas \& Porfeli, 2012) measures an individual's psychosocial readiness and resources for coping with current and imminent vocational development tasks, occupational transitions, and work traumas using four scales which measure concern, control, curiosity, and confidence. Internal consistency estimates for the subscale and total scores ranged from good to excellent i.e. .82 to .88. Concurrent validity evidence was found to be strong between the subscales of CAAS and the Vocational Identity Status Assessment (VISA; Porfeli, Lee, Vondracek, \& Weigold, 2011)
Career Thoughts Inventory (CTI; Sampson et al., 1996)
Time frame: 12 months
The CTI consists of 48 Likert-scale items rated on a 4-point agree scale representing typical dysfunctional/negative career thoughts including Decision-Making Confusion, Commitment Anxiety, and External Conflict. The CTI developers report alpha coefficients for the total score ranging from .93 to .97; and for the subscales ranged from .74 to .94. The authors also provide support for the CTI's construct validity, convergent validity, and criterion validity.
Behavior and Symptom Identification Scale (BASIS - 24) (Eisen, et al., 2004, Eisen et al., 2006)
Time frame: 12 months
The BASIS-24 is designed to measure mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use using a 5-point Likert-type scale. Extensive and excellent reliability and validity data exists for the instrument from a national study involving over 5,000 participants (Eisen, et al., 2004; Eisen, et al., 2006)
Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988)
Time frame: 12 months
Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988) measures both objective and subjective quality of life across multiple domains including living situation, family relations, social relations, work, and the like. It has considerable psychometric data suggesting adequate validity and reliability (Lehman, 1995; Russo et al., 1997). We will employ 2 items from this scale: the subjective measures of life in general and work satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erna S. Rogers, Sc.D. principal investigator
Boston University Center for Psychiatric Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opening Doors in people with Psychiatric Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment and Vocational Activities Checklist (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.