DepressionNCT02314624

PracticeGround: Transforming Training and Delivery of Mental Health EBPs

A study testing Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality and Care-as-Usual Psychotherapy in people with Depression and Insomnia, run by Evidence-Based Practice Institute, Seattle, WA 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Insomnia, Suicide
What is being tested?: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality and Care-as-Usual Psychotherapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteUnited States
Study dates: Dec 2014to 31 Dec 2018
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

Meets DSM-IV criteria for MDD and/or DD
Obtains a score of 11 or greater on the PHQ-9
Currently receiving psychosocial treatment for depression by a study-participant clinician
Payment-eligible to receive at least 12 weeks of additional psychosocial treatment
English speaker
18 years or older

Show all 10Show fewer

Currently licensed mental health treatment provider (or a therapist working towards licensure under direct supervision of licensed mental health treatment provider)
Have an office with access to internet
Have access to computer with sound card and/or tablet and printer
Capacity to accept new patients seeking treatment for depressive symptoms

Who cannot join

Current diagnosis of bipolar disorder or another psychotic disorder
Active mania
Current diagnosis of alcohol and/or drug dependence
At imminent risk of suicide (as deemed by their clinician).
PROVIDERS
(PILOT ONLY) Receiving training for an evidence based treatment for depression, including behavioral activation, interpersonal therapy, cognitive/cognitive-behavioral therapy, mindfulness-based cognitive therapy or cognitive behavioral analysis system of psychotherapy

Show all 9Show fewer

Participated in the Field Test for WILLOW
Is not comfortable/savvy with technology (by answering "I get easily frustrated and usually walk away from it" to the question "Which response best matches how you typically respond to complicated problems you encounter when using a new app, computer, or technology for the first time?"; answering "I am not comfortable and/or do not enjoy technology, particularly new forms of technology. I avoid the use of technology as much as is realistically possible." to the question "How technologically savvy/skilled are you?")
Does not have a feasible office set up for using a computer in therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Evidence-Based Practice Institute
Seattle, Washington, 98121

Other trials in United States

About this study

The ultimate goal is to facilitate the delivery of empirically supported treatments (ESTs) for mental disorders and to improve client mental health outcomes. Toward this end, this Phase II SBIR proposal seeks to complete the development and testing of PracticeGround, a comprehensive software system designed to integrate with electronic health records, and that contains multiple methods of training clinicians in ESTs and delivering ESTs to clients, continuous progress monitoring of client outcomes, and clinical support tools to guide clinicians and clients through delivery of the necessary EST. The investigators will conduct an 18-week randomized controlled trial (N=80) comparing PracticeGround (n=40) to care-as-usual (n=40) in depressed outpatient clients. PracticeGround clinicians will have full access to the software. Study clinicians and clients will be assessed once every six weeks (baseline, 6, 12, and 18 weeks). To ensure generalizability of findings, the investigators will not control for natural therapy variations (e.g.,session frequency, medication use, etc.). Primary outcomes include: depression, psychological distress, treatment satisfaction (clients and clinicians), and treatment drop out. Secondary clinician outcomes include: extent of PracticeGround use with clients across clinicians' caseload.

Conditions: Depression, Insomnia, Suicide
Being tested: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality, Care-as-Usual Psychotherapy
Medical subject headings: Depression, Sleep Initiation and Maintenance Disorders, Suicide

What participants receive

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

Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of SuicidalityBehavioural
Evidence-based interventions for treating depression and concurrent problems
Care-as-Usual PsychotherapyBehavioural
Usual care psychotherapy for depression and concurrent problems

Study groups in NCT02314624
Study group	Role	What they receive
WILLOW	Experimental	Clinicians have access to WILLOW's dynamic progress monitoring, clinical decision support, rich visual displays of client outcomes, online training modules in ESTs, just-in-time training for guided real-time assistance in delivering ESTs, educational videos, and a client portal Receives: Behavioral: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality
Treatment-as-Usual	Active comparator	Usual care without access to WILLOW. Receives: Behavioral: Care-as-Usual Psychotherapy

What is being measured

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

Depression, Anxiety, and Stress Scale (DASS)
Higher scores on subscales from this 23-item measure reflected higher depression, anxiety, stress, and suicidality. Other researchers added two suicidality items to the original 21-item measure with permission from the original authors. Each subscale score is computed by summing the subscale items, then multiplying by 2. Total possible scores for the depression, anxiety, and stress subscales range from 0-42. We categorized DASS depression, anxiety, and stress scores into severity levels coded as 0, 1, and 2: Normal (0 through 9), Mild/moderate (10 through 20), and Severe/extremely severe (21 through 42) (Psychology Foundation of Australia, 2018). The DASS suicide subscale ranged from 0-12 and not recategorized.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Beck Depression Inventory (BDI-II)
Higher scores on this 21-item reflect greater depressive symptoms in the past two weeks. All items are summed to a total score (possible range 0-63). We categorized BDI scores into severity levels coded as 0, 1, and 2: Minimal (raw scores 0 through 13), Mild/moderate (14 through 28), and Severe (29 through 63).
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Higher scores on this ten-item measure reflects more severe depression. The total score (possible range 0-27) is created by summing the first nine items. We categorized PHQ severity levels coded as 0, 1, and 2 based on authors' research as minimal (0 through 4), mild/moderate (5 through 14), and moderately severe/severe (15 through 27). The recategorized scores are reported here.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Behavioral Activation for Depression Scale Short Form (BADS-SF)
The Behavioral Activation for depression Scale Short Form has 9 questions each having a scale from 0 (Not at All) to 6 (Completely) with a total range of 0-54. Higher scores on this nine-item scale reflect lower engagement in avoidance and higher engagement in activation behaviors over the course of BA for depression.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Mental Health Services Satisfaction Survey (MHSSS)
We created a ten-item measure in which higher scores reflected greater satisfaction with services they received. The measure had 10 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 10-50. Higher scores indicated a better outcome.
Measured: After first study therapy session, 4 weeks, 8 weeks, 12 weeks
Working Alliance Inventory (WAI)
We modified this measure to include items from the BHS from Group Health. The resulting 12-item scale measures the therapeutic relationship with higher scores indicating stronger alliance. With 12 questions and each having a scale of 1(Never) to 7(Always) the total range was 12-84.
Measured: 4 weeks, 8 weeks, 12 weeks
Therapy Task Checklist (TTC) - Patient Version
We developed the TTC. The Therapy Task Checklist-Patient Version with 25 questions and each having a scale of 0 (Never/Very Rarely) to 7 (All of the Time) has a total range of 0-100. Higher scores reflected more frequent use of evidence-based therapy tasks, positive outcomes.
Measured: 4 weeks, 8 weeks, 12 weeks
Modified Practice Attitudes Scale (MPAS)
The Modified Practice Attitudes Scale with eight questions, each having a scale of 0 (Not at all) to 4(To a very great extent), has a total range of 0-32. Higher scores on this eight-item scale reflect more positive attitudes towards evidence-based practices.
Measured: Baseline, 12 weeks
Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)
The Perceptions of Computer-Assisted Therapy Questionnaire has 34 questions each having a scale of 1(Strongly Disagree) to 7 Strongly Agree). Thus, the total range was 34-238. Higher scores on this 34-item scale indicate stronger agreement with the benefits of computer-assisted therapy, or a better outcome.
Measured: Baseline, 12 weeks
ASA-Monitoring and Feedback Version (ASA-MF)
The ASA-Monitoring and Feedback Version (ASA-MF) measure has 18 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 18-90. Higher scores on this 18-item scale reflect positive attitudes about standardized and routine progress monitoring, or positive outcomes.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Monitoring and Feedback Attitudes Scale (MFA)
The Monitoring and Feedback Attitudes Scale has 14 questions and each has a scale of 1(Strongly Disagree) to 5(Strongly Agree), thus the total range was 14-70. Higher scores on this 14-item measure indicate more positive attitudes about routine progress monitoring and providing feedback to patients about treatment progress, or positive outcomes.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Routine Monitoring (RM)
We created a three-item measure where the total score is found by summing the items. The first two items are yes(scored 1)/no(scored 0) questions. The last item is a count measure that can be any number greater than or equal to 0. Thus, the total score can have any integer value greater than or equal to 0, with higher scores reflecting greater use of routine progress monitoring.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Current Assessment Practice Evaluation-Revised (CAPER)
We modified the original measure into nine items. The Current Assessment Practice Evaluation-Revised has 9 questions with each having a scale of 1(None, 0%) to 5 (Nearly All, 81-100%). Thus, the total range was 9-45 and higher scores reflect greater provider use of measurement-based care or positive outcomes.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Therapy Task Checklist (TTC) - Provider Version
The Therapy Task Checklist -Provider Version has 22 questions and each have a scale of 0(Never/Very Rarely) to 4 (All of the time) with a total range of 0-88. Higher scores reflected more frequent use of evidence-based therapy tasks, or positive outcomes.
Measured: 4 weeks, 8 weeks, 12 weeks

Timeline

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

Dec 201431 Dec 2018

First posted11 Dec 2014 (estimated)
Study startDec 2014
Primary completion31 Dec 2018
Study completion31 Dec 2018

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.
Other trials for DepressionStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314624
Sponsor's protocol ID: 2R44MH093993-02A1
Status last verified: Aug 2024
First submitted: 5 Dec 2014
Last updated: 30 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PracticeGround: Transforming Training and Delivery of Mental Health EBPs
ClinicalTrials.gov ID: NCT02314624
Acronym / sponsor ID: 2R44MH093993-02A1
Conditions: Depression, Insomnia, Suicide
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Evidence-Based Practice Institute, Seattle, WAIndustry (pharma, biotech, devices)
Study start: Dec 2014 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 15 Jun 2023

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
WILLOW	Experimental	Behavioral: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of SuicidalityClinicians have access to WILLOW's dynamic progress monitoring, clinical decision support, rich visual displays of client outcomes, online training modules in ESTs, just-in-time training for guided real-time assistance in delivering ESTs, educational videos, and a client portal
Treatment-as-Usual	Active comparator	Behavioral: Care-as-Usual PsychotherapyUsual care without access to WILLOW.

Who may qualify

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

Key inclusion criteria (10 listed)

Meets DSM-IV criteria for MDD and/or DD
Obtains a score of 11 or greater on the PHQ-9
Currently receiving psychosocial treatment for depression by a study-participant clinician
Payment-eligible to receive at least 12 weeks of additional psychosocial treatment
English speaker

Key exclusion criteria (9 listed)

Current diagnosis of bipolar disorder or another psychotic disorder
Active mania
Current diagnosis of alcohol and/or drug dependence
At imminent risk of suicide (as deemed by their clinician).
PROVIDERS

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
Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of SuicidalityEvidence-based interventions for treating depression and concurrent problems	Behavioural	WILLOW
Care-as-Usual PsychotherapyUsual care psychotherapy for depression and concurrent problems	Behavioural	Treatment-as-Usual

Primary outcome

Depression, Anxiety, and Stress Scale (DASS)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Higher scores on subscales from this 23-item measure reflected higher depression, anxiety, stress, and suicidality. Other researchers added two suicidality items to the original 21-item measure with permission from the original authors. Each subscale score is computed by summing the subscale items, then multiplying by 2. Total possible scores for the depression, anxiety, and stress subscales range from 0-42. We categorized DASS depression, anxiety, and stress scores into severity levels coded as 0, 1, and 2: Normal (0 through 9), Mild/moderate (10 through 20), and Severe/extremely severe (21 through 42) (Psychology Foundation of Australia, 2018). The DASS suicide subscale ranged from 0-12 and not recategorized.
Beck Depression Inventory (BDI-II)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Higher scores on this 21-item reflect greater depressive symptoms in the past two weeks. All items are summed to a total score (possible range 0-63). We categorized BDI scores into severity levels coded as 0, 1, and 2: Minimal (raw scores 0 through 13), Mild/moderate (14 through 28), and Severe (29 through 63).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Higher scores on this ten-item measure reflects more severe depression. The total score (possible range 0-27) is created by summing the first nine items. We categorized PHQ severity levels coded as 0, 1, and 2 based on authors' research as minimal (0 through 4), mild/moderate (5 through 14), and moderately severe/severe (15 through 27). The recategorized scores are reported here.
Behavioral Activation for Depression Scale Short Form (BADS-SF)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The Behavioral Activation for depression Scale Short Form has 9 questions each having a scale from 0 (Not at All) to 6 (Completely) with a total range of 0-54. Higher scores on this nine-item scale reflect lower engagement in avoidance and higher engagement in activation behaviors over the course of BA for depression.
Mental Health Services Satisfaction Survey (MHSSS)
Time frame: After first study therapy session, 4 weeks, 8 weeks, 12 weeks
We created a ten-item measure in which higher scores reflected greater satisfaction with services they received. The measure had 10 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 10-50. Higher scores indicated a better outcome.
Working Alliance Inventory (WAI)
Time frame: 4 weeks, 8 weeks, 12 weeks
We modified this measure to include items from the BHS from Group Health. The resulting 12-item scale measures the therapeutic relationship with higher scores indicating stronger alliance. With 12 questions and each having a scale of 1(Never) to 7(Always) the total range was 12-84.
Therapy Task Checklist (TTC) - Patient Version
Time frame: 4 weeks, 8 weeks, 12 weeks
We developed the TTC. The Therapy Task Checklist-Patient Version with 25 questions and each having a scale of 0 (Never/Very Rarely) to 7 (All of the Time) has a total range of 0-100. Higher scores reflected more frequent use of evidence-based therapy tasks, positive outcomes.
Modified Practice Attitudes Scale (MPAS)
Time frame: Baseline, 12 weeks
The Modified Practice Attitudes Scale with eight questions, each having a scale of 0 (Not at all) to 4(To a very great extent), has a total range of 0-32. Higher scores on this eight-item scale reflect more positive attitudes towards evidence-based practices.
Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)
Time frame: Baseline, 12 weeks
The Perceptions of Computer-Assisted Therapy Questionnaire has 34 questions each having a scale of 1(Strongly Disagree) to 7 Strongly Agree). Thus, the total range was 34-238. Higher scores on this 34-item scale indicate stronger agreement with the benefits of computer-assisted therapy, or a better outcome.
ASA-Monitoring and Feedback Version (ASA-MF)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The ASA-Monitoring and Feedback Version (ASA-MF) measure has 18 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 18-90. Higher scores on this 18-item scale reflect positive attitudes about standardized and routine progress monitoring, or positive outcomes.
Monitoring and Feedback Attitudes Scale (MFA)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Monitoring and Feedback Attitudes Scale has 14 questions and each has a scale of 1(Strongly Disagree) to 5(Strongly Agree), thus the total range was 14-70. Higher scores on this 14-item measure indicate more positive attitudes about routine progress monitoring and providing feedback to patients about treatment progress, or positive outcomes.
Routine Monitoring (RM)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
We created a three-item measure where the total score is found by summing the items. The first two items are yes(scored 1)/no(scored 0) questions. The last item is a count measure that can be any number greater than or equal to 0. Thus, the total score can have any integer value greater than or equal to 0, with higher scores reflecting greater use of routine progress monitoring.
Current Assessment Practice Evaluation-Revised (CAPER)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
We modified the original measure into nine items. The Current Assessment Practice Evaluation-Revised has 9 questions with each having a scale of 1(None, 0%) to 5 (Nearly All, 81-100%). Thus, the total range was 9-45 and higher scores reflect greater provider use of measurement-based care or positive outcomes.
Therapy Task Checklist (TTC) - Provider Version
Time frame: 4 weeks, 8 weeks, 12 weeks
The Therapy Task Checklist -Provider Version has 22 questions and each have a scale of 0(Never/Very Rarely) to 4 (All of the time) with a total range of 0-88. Higher scores reflected more frequent use of evidence-based therapy tasks, or positive outcomes.

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WILLOW	80	49
Treatment-as-Usual	62	36

Primary outcome: Depression, Anxiety, and Stress Scale (DASS)

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	WILLOW n = 31	Treatment-as-Usual n = 25
Baseline (depression subscale)	1.55 (.68)	1.68 (.56)
Week 4 (depression subscale)	1.32 (.79)	1.4 (.65)
Week 8 (depression subscale)	1.1 (.75)	1.08 (.76)
Week 12 (depression subscale)	.94 (.94)	1.08 (.76)
Baseline (anxiety subscale)	.97 (.8)	.84 (.75)
Week 4 (anxiety subscale)	.81 (.75)	.76 (.78)
Week 8 (anxiety subscale)	.74 (.77)	.76 (.83)
Week 12 (anxiety subscale)	.58 (.81)	.72 (.74)

WILLOW vs Treatment-as-Usual: p = .734, Chi-squared
WILLOW vs Treatment-as-Usual: p = .27, Chi-squared
WILLOW vs Treatment-as-Usual: p = .75, Chi-squared

Population analysed: Patient participants

Primary outcome: Beck Depression Inventory (BDI-II)

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	WILLOW n = 31	Treatment-as-Usual n = 25
Baseline	1.25 (.63)	1.52 (.65)
Week 4	1.16 (.82)	1.12 (.78)
Week 8	1.00 (.78)	1.08 (.76)
Week 12	.71 (.86)	1.04 (.74)

WILLOW vs Treatment-as-Usual: p = .036, Chi-squared

Population analysed: Patient participants

Primary outcome: Patient Health Questionnaire-9 (PHQ-9)

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	WILLOW n = 31	Treatment-as-Usual n = 25
Baseline	1.48 (.57)	1.44 (.58)
Week 4	1.23 (.62)	1.24 (.60)
Week 8	1.24 (.64)	1.28 (.61)
Week 12	.97 (.71)	1.08 (.76)

WILLOW vs Treatment-as-Usual: p = .664, Chi-squared

Population analysed: Patient participants

Primary outcome: Behavioral Activation for Depression Scale Short Form (BADS-SF)

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	WILLOW n = 31	Treatment-as-Usual n = 25
Baseline	18.8 (7.37)	17.3 (6.47)
Week 4	23.4 (9.42)	20.4 (6.68)
Week 8	24.6 (9.05)	21.3 (7.52)
Week 12	27.7 (8.42)	23.6 (7.88)

WILLOW vs Treatment-as-Usual: p = .764, Chi-squared

Population analysed: Patient Participants

Adverse events

Time frame: Adverse event data reporting was open throughout periods of recruitment and active participation of approximately 1 year and 8 months. It is noted that no adverse events were reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WILLOW	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Treatment-as-Usual	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Limitations and caveats (from the sponsor): Overall study recruitment was lower than anticipated (target n=110). To address this, data from both pilot and full RCTs were included to maximize sample size and the Generalized Linear Model was used as it yields more power with missing data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 9 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 30 Aug 2024. 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 15 Jun 2023). 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?

Depression, Anxiety, and Stress Scale (DASS) (time frame: baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 14 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 NCT02314624.

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 30 Aug 2024.