Mental DisordersWRAP RCTNCT01024569

Randomized Controlled Trial of Wellness Recovery Action Planning

A study testing Wellness Recovery Action Planning (WRAP) in people with Mental Disorders, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mental Disorders
What is being tested?: Wellness Recovery Action Planning (WRAP)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 555 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Oct 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

age 18 years or older
English speaking
severe mental illness as confirmed by: 1) a Kessler Self-Report Measure (K-6) score of 13 or higher; and/or 2) enrolled as a client of the public mental health system in the state of Ohio.

Who cannot join

non English speaking
not meeting clinical criteria for severe mental illness

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois at Chicago, Department of Psychiatry
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio

The purpose of this research study is to test the effectiveness of a standardized peer-led intervention to teach self-management skills in improving outcomes of individuals with a severe mental illness. The intervention is known as Wellness Recovery Action Planning or WRAP, co-developed by Dr. Mary Ellen Copeland. The focus of the inquiry is on whether and how developing an individualized plan for successful living: 1) lowers psychiatric symptoms; 2) enhances psychosocial outcomes such as self-perceived recovery, empowerment, self-advocacy, coping, and social support; 3) increases knowledge of personal mental illness self-management strategies; and 4) enhances satisfaction with the service delivery system. The study evaluated the following hypotheses:

Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP intervention will report reduced levels of psychiatric symptoms.

Hypothesis #2: Compared to wait-list control subjects, those who participate in the WRAP intervention will report enhanced enhanced feelings of empowerment, hope, recovery, quality of life, and functioning.

Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention will report increased levels of social support.

Hypothesis #4: Compared to wait-list controls, those who participate in the WRAP intervention will report increased use of peer services, higher satisfaction with services, and have lower overall service costs.

Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will report increased knowledge of mental illness self-management, including making/using a WRAP plan.

Hypothesis #6: There will be no difference in employment rates of control vs. intervention subjects.

Read the detailed description

Eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. All study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). Blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; quality of life, and functioning. All study participants were compensated for their time at each interview. All WRAP facilitators were people in recovery from serious mental illnesses who were certified and experienced WRAP facilitators. Fidelity to the WRAP curriculum was assessed on an ongoing basis throughout the study.

Conditions: Mental Disorders
Being tested: Wellness Recovery Action Planning (WRAP)
Keywords: Severe Mental Illness, Recovery, Psychiatric Disability, Wellness, Peer Service, WRAP
Medical subject headings: Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Wellness Recovery Action Planning (WRAP)Behavioural
WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.

Study groups in NCT01024569
Study group	Role	What they receive
Wellness Recovery Action Planning (WRAP)	Experimental	WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues. Receives: Behavioral: Wellness Recovery Action Planning (WRAP)
Comparison Wait-List Group	No intervention	Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.

What is being measured

The primary outcome is the main question the study is designed to answer.

Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
The BSI is a patient self-report mental health symptoms research instrument (Piersma et al., 1994). Respondents are asked how much they were bothered in the past week by 53 symptoms on 9 dimensions with a 5-point response scale ranging from ''not at all'' to ''extremely.'' We assessed the BSI Positive Symptom Score which captures the number of symptoms endorsed in a pathological direction, representing the total volume of different symptoms reported to be present to any degree. The minimum value is 0 and the maximum score is 212, where higher scores mean a worse outcome.
Measured: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
Hopefulness
Hopefulness is measured by the State Hope Scale. Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from "definitely false" to "definitely true" and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income.
Measured: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
Patient Self-Advocacy
The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale, an 18-item scale with a 5-point Likert response set ranging from "strongly disagree" to "strongly agree". Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Values range from a minimum of 18 to a maximum of 90, with higher scores indicating a better outcome.
Measured: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
Recovery From Mental Illness
This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms.
Measured: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Secondary outcomes (1)

Quality of Life Brief Assessment
Quality of Life was assessed by the World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF). The 8-item environment sub-scale was utilized for our study. Respondents rate their experience of 8 quality indicators over the past 2 weeks using a 5-point Likert response scale. The minimum value is 8 and the maximum is 40, with higher scores meaning better outcomes.
Measured: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Oct 2009

First posted3 Dec 2009 (estimated)
Study startDec 2007
Primary completionSep 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Mental DisordersStudies of the same condition, open and under way.
More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 555 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01024569
Sponsor's protocol ID: 2006-0103
Other IDs: UIC WRAP Study
Acronym: WRAP RCT
Status last verified: Dec 2019
First submitted: 2 Dec 2009
Last updated: 10 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cook JA, Copeland ME, Jonikas JA, Hamilton MM, Razzano LA, Grey DD, Floyd CB, Hudson WB, Macfarlane RT, Carter TM, Boyd S. Results of a randomized controlled trial of mental illness self-management using Wellness Recovery Action Planning. Schizophr Bull. 2012 Jun;38(4):881-91. doi: 10.1093/schbul/sbr012. Epub 2011 Mar 14.
PubMed 21402724
Cook JA, Copeland ME, Floyd CB, Jonikas JA, Hamilton MM, Razzano L, Carter TM, Hudson WB, Grey DD, Boyd S. A randomized controlled trial of effects of Wellness Recovery Action Planning on depression, anxiety, and recovery. Psychiatr Serv. 2012 Jun;63(6):541-7. doi: 10.1176/appi.ps.201100125.
PubMed 22508435
Jonikas JA, Grey DD, Copeland ME, Razzano LA, Hamilton MM, Floyd CB, Hudson WB, Cook JA. Improving propensity for patient self-advocacy through wellness recovery action planning: results of a randomized controlled trial. Community Ment Health J. 2013 Jun;49(3):260-9. doi: 10.1007/s10597-011-9475-9. Epub 2011 Dec 14.
PubMed 22167660
Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.
PubMed 8636885
Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042.
PubMed 29407723
Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.
PubMed 16370972
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio
ClinicalTrials.gov ID: NCT01024569
Acronym / sponsor ID: WRAP RCT / 2006-0103
Conditions: Mental Disorders
Keywords: Severe Mental Illness, Recovery, Psychiatric Disability, Wellness, Peer Service, WRAP
Study type: Interventional
Recruitment status: Completed
Enrolment: 555 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Collaborators: U.S. Department of Education, Substance Abuse and Mental Health Services Administration (SAMHSA)
Study start: Dec 2007
Primary completion: Sep 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 3 Dec 2009 (estimated)
Results: Posted 10 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP intervention will report reduced levels of psychiatric symptoms.

Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention will report increased levels of social support.

Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will report increased knowledge of mental illness self-management, including making/using a WRAP plan.

Hypothesis #6: There will be no difference in employment rates of control vs. intervention subjects.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Wellness Recovery Action Planning (WRAP)	Experimental	Behavioral: Wellness Recovery Action Planning (WRAP)WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.
Comparison Wait-List Group	No intervention	–Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age 18 years or older
English speaking
severe mental illness as confirmed by: 1) a Kessler Self-Report Measure (K-6) score of 13 or higher; and/or 2) enrolled as a client of the public mental health system in the state of Ohio.

Key exclusion criteria (2 listed)

non English speaking
not meeting clinical criteria for severe mental illness

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
Wellness Recovery Action Planning (WRAP)WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.	Behavioural	Wellness Recovery Action Planning (WRAP)

Primary outcome

Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
The BSI is a patient self-report mental health symptoms research instrument (Piersma et al., 1994). Respondents are asked how much they were bothered in the past week by 53 symptoms on 9 dimensions with a 5-point response scale ranging from ''not at all'' to ''extremely.'' We assessed the BSI Positive Symptom Score which captures the number of symptoms endorsed in a pathological direction, representing the total volume of different symptoms reported to be present to any degree. The minimum value is 0 and the maximum score is 212, where higher scores mean a worse outcome.
Hopefulness
Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
Hopefulness is measured by the State Hope Scale. Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from "definitely false" to "definitely true" and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income.
Patient Self-Advocacy
Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale, an 18-item scale with a 5-point Likert response set ranging from "strongly disagree" to "strongly agree". Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Values range from a minimum of 18 to a maximum of 90, with higher scores indicating a better outcome.
Recovery From Mental Illness
Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms.

1 secondary outcome

Quality of Life Brief Assessment
Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Results and safety

Results posted to the registry on 10 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wellness Recovery Action Planning (WRAP)	276	251
Comparison Wait-List Group	279	268

Primary outcome: Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)

Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry). Mean (Standard Deviation). Unit: symptom severity score

Measure	Experimental n = 251	Control n = 268
Baseline	20.6 (14.67)	19.29 (14.09)
Postintervention 1	19.52 (13.74)	21.38 (13.68)
Postintervention 2	12.20 (15.22)	12.65 (15.00)

Experimental vs Control: MIXREG Estimate: -1.16, p = 0.027, Mixed Effects Random Regression

Primary outcome: Hopefulness

Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry). Mean (Standard Deviation). Unit: Score on a Scale

Measure	Wellness Recovery Action Planning (WRAP) n = 248	Comparison Wait-List Group n = 264
Baseline	21.67 (4.66)	21.87 (4.42)
Post-intervention 1	22.47 (4.39)	22.07 (4.06)
Post-intervention 2	22.76 (4.68)	22.16 (4.21)

Wellness Recovery Action Planning (WRAP) vs Comparison Wait-List Group: MIXREG Estimate: 0.40, p = 0.020, Mixed Effects Random Regression

Population analysed: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.

Primary outcome: Patient Self-Advocacy

Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry). Mean (Standard Error). Unit: Score on a Scale

Measure	Experimental n = 251	Control n = 268
Baseline (Time 1)	3.47 (0.50)	3.46 (0.53)
Post-intervention 1 (Time 2)	3.61 (0.52)	3.53 (0.53)
Post-intervention 2 (Time 3)	3.65 (0.52)	3.55 (0.49)

Experimental vs Control: MIXREG Estimate: 0.05, p = 0.029, Mixed Effects Random Regression

Population analysed: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline

Primary outcome: Recovery From Mental Illness

Time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry). Mean (Standard Deviation). Unit: score on a scale

Measure	Experimental n = 248	Control n = 265
Baseline (Time 1)	88.2 (14.9)	87.4 (13.2)
Post-intervention 1 (Time 2)	92.9 (14.2)	90.0 (13.7)
Post-intervention 2 (Time 3)	93.7 (14.7)	91.2 (13.1)

Experimental vs Control: MIXREG Estimate: 1.06, p = 0.042, Mixed Effects Random Regression

Population analysed: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wellness Recovery Action Planning (WRAP)	0 of 268 (0%)	1 of 268 (0.4%)	4 of 268
Comparison Wait-List Group	0 of 251 (0%)	1 of 251 (0.4%)	6 of 251

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21402724Cook JA, Copeland ME, Jonikas JA, Hamilton MM, Razzano LA, Grey DD, Floyd CB, Hudson WB, Macfarlane RT, Carter TM, Boyd S. Results of a randomized controlled trial of mental illness self-management using Wellness Recovery Action Planning. Schizophr Bull. 2012 Jun;38(4):881-91. doi: 10.1093/schbul/sbr012. Epub 2011 Mar 14.
Results publication: PubMed 22508435Cook JA, Copeland ME, Floyd CB, Jonikas JA, Hamilton MM, Razzano L, Carter TM, Hudson WB, Grey DD, Boyd S. A randomized controlled trial of effects of Wellness Recovery Action Planning on depression, anxiety, and recovery. Psychiatr Serv. 2012 Jun;63(6):541-7. doi: 10.1176/appi.ps.201100125.
Results publication: PubMed 22167660Jonikas JA, Grey DD, Copeland ME, Razzano LA, Hamilton MM, Floyd CB, Hudson WB, Cook JA. Improving propensity for patient self-advocacy through wellness recovery action planning: results of a randomized controlled trial. Community Ment Health J. 2013 Jun;49(3):260-9. doi: 10.1007/s10597-011-9475-9. Epub 2011 Dec 14.
Results publication: PubMed 8636885Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.
Results publication: PubMed 29407723Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042.
Results publication: PubMed 16370972Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.
Results publication: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
University of Illinois at Chicago National Research \& Training CenterLink provided by the sponsor.

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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.

Judith A. Cook, PhD principal investigator

University of Illinois at Chicago, Department of Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wellness Recovery Action Planning (WRAP) in people with Mental Disorders, run by University of Illinois Chicago 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 3 inclusion and 2 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 10 Jan 2020. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) (time frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01024569, which also lists 7 linked publications.

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 10 Jan 2020.