Anxiety DepressionNCT05799794
Optimizing Implementation Coaching to Support Successful EBP Delivery
A study testing Supervisor-led Implementation Coaching in people with Anxiety Depression and Mental Health Issue, run by University of Washington at 1 site in United States.
Trial summary
This project engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Depression, Mental Health Issue
- What is being tested?
- Supervisor-led Implementation Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 29 Oct 2024
- 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
- Supervisors in aim 1a and clinicians/supervisors in aim 2 must
- be employed in CMHCs whose leadership has agreed to participate in the study
- have participated or be participating in the Initiative.
- Clinicians in aim 1b do not need to be employed in a CMHC whose leadership has agreed to participate in the study.
Who cannot join
- There is no exclusion criteria for supervisors in Aim 1a or clinicians in 1b.
- Supervisors who participate in Aim 1 will be excluded from participating in Aim 2 as recipients of Implementation Coaching.
- Supervisor coaches will be recruited from the supervisors that participated in Aim 2. There is no exclusion criteria for clinicians in Aim 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Implementation Coaching to Improve Treatment Quality and Client Outcomes in Community Mental Health Centers
This project engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. The optimized coaching strategy has the potential to enhance the adoption and fidelity of evidence-based practice (EBP).
Read the detailed description
The Washington State EBP Initiative provides clinical training and consultation for Cognitive Behavioral Therapy (CBT) and some basic organizational support; however, consistent with the literature, community mental health centers (CMHCs) often need more to successfully implement CBT. To accelerate treatment quality and clinical outcomes for youth, CMHCs need practical strategies for "successfully implementing, sustaining, and improving" EBPs that can be tailored to fit their specific context. These strategies will have the greatest impact if designed and delivered by CMHC practice community members who have CMHC-specific EBP implementation experience and expertise.
Implementation facilitation, a multifaceted, dynamic strategy of interactive problem-solving and support, improves adoption and fidelity of interventions. Implementation facilitation may be a promising strategy for CMHCs, but the resources and demands of traditional facilitation may present challenges for CMHCs. Motivated by global mental health frugal innovations work, the Principal Investigator piloted a modified facilitation approach for CMHCs, Implementation Coaching (hereafter "Coaching"), delivered to CMHCs participating in the Initiative. Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The investigator led coaching, supporting supervisors in developing workplans for CBT implementation in their CMHCs across 3 implementation phases. Coaching recommends a limited set of implementation strategies in each phase (e.g., Implementation phase: local technical assistance) that address known, prioritized determinants. Supervisors are supported in tailoring strategies for their CMHCs. In the pilot, CMHCs that received Coaching had clinicians that engaged in CBT delivery earlier and with more youth. Qualitative interviews suggested that supervisors were engaged and found Coaching acceptable and feasible. Based on the pilots' success, Project 2 will engage CMHC supervisors in: a) co-designing an optimized version of Coaching, and b) leading Coaching for other supervisors to optimize CBT implementation in their CMHCs.
In this exploratory research project, the Investigators' goal is to extend a pilot study that included the development and implementation of Implementation Coaching (hereafter "Coaching") within the Washington State EBP Initiative. In the pilot, the Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The results of the pilot indicated that Coaching was acceptable and feasible. In the current study, in collaboration with CMHC supervisors, investigators aim to optimize and test the effectiveness of Coaching for improving CBT fidelity and youth outcomes for four common conditions in CMHCs. The hypothesized mechanism through which Coaching operates is implementation climate or the degree to which an organization expects, supports, and rewards an innovation. Investigators expect that Coaching can be most effective in supporting CMHCs' high-quality EBP implementation if optimized with the practice community (supervisors) for the goals of limited resource use, fit with CMHC workflow, and wider reach. Coaching reach can be improved by moving beyond delivery by University-based personnel. In the Initiative, peer CMHC supervisors with CBT experience and expertise already co-lead CBT clinical training.
The study includes the following aims: Aim 1a) Collaborating with CMHCs, investigators will identify and convene purposively sampled groups of supervisors for diverse perspectives and demographics (e.g., ethnically diverse supervisors/clientele; urban/rural) during 2 one-day, in-person Ideation workshops; Aim 1b) Up to 150 clinicians will be recruited through the Initiative listserv and CBT+ training (for clinicians who recently completed their training) to participate in an online study in which clinicians will be randomized to read up to 6 vignettes that describe different strategies developed in the ideation phase and complete a survey with relevant subscale/s of implementation climate (EBP use is expected, supported and rewarded); Aim 2) Clinicians will be randomly assigned to receive standard implementation support or standard implementation support plus Coaching by trained supervisors.
- Conditions
- Anxiety Depression, Mental Health Issue
- Being tested
- Supervisor-led Implementation Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervisor-led Implementation CoachingBehavioural
Also called Facilitation; Implementation Support
Implementation coaching, support, or facilitation includes the support provided to supervisors and their organizations for successfully delivering an evidence-based practice (EBP). Implementation support can include consultation, supervision, and coaching.
| Study group | Role | What they receive |
|---|---|---|
| Standard/As Usual CBT+/EBP Initiative Implementation | Active comparator | All CMHCs involved in the CBT+/EBP Initiative receive virtual clinician training, CBT-phone consultation options over 6-months, access to a supervisor monthly call, listservs (one supervisor-focused), and a yearly advanced clinical training and supervisor training. The Initiative is a program that has been ongoing since 2009. Receives: Behavioral: Supervisor-led Implementation Coaching |
| Supervisor-led Implementation Coaching | Experimental | The structure of this arm will depend on Aim 1. However, the investigators imagine that peer supervisors leading implementation coaching, trained in Aim 1, will have 3-5 virtual meetings with supervisors and email communication. Meetings focus on orientation to the theory and rationale for Coaching and supervisors' role as frontline leaders to support EBP implementation. Meetings are likely over 6 months and focus on different implementation phases. Coaches will support supervisors in developing tailored workplans for implementation in their CMHCs. In each meeting, the coach will review the strategies in the workplan, provide examples of how the strategy could be specified, and then facilitate discussion among supervisors. The coach will support supervisors in building a tailored workplan for their CMHC. Supervisors in the Coaching condition receive Coaching plus standard Initiative Implementation support. Receives: Behavioral: Supervisor-led Implementation Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBT Fidelity
Clinicians participating in the Initiative, and who participate in this study, routinely enter session and de-identified CBT client outcome data. The investigative team will code cases enrolled study clinicians enter into the de-identified Dashboard. Based on the CBT model the clinician specifies, investigators will code cases for delivery of "essential elements" of that CBT model for each of the mental health conditions of focus: Anxiety, Depression, Posttraumatic Stress, and Behavioral Problems. Essential element coding will produce a count and a "fidelity" ratio of sessions including essential CBT elements (vs. only other elements) for each client, specific to the CBT model they received. Higher scores represent higher CBT fidelity reflecting greater essential element delivery (content) and coverage (dose).
Measured: through study completion, an average of 7 months
Secondary outcomes (4)
Externalizing Behavior Symptoms
Also to be entered in the de-identified online dashboard, the externalizing subscale of the Pediatric Symptom Checklist (PSC-17) will be used to assess externalizing symptoms for youth receiving CBT for behavior problems. The full PSC-17 consists of 17 items rated using a 3-point Likert scale, with three subscales: externalizing (7-items; items used for this outcome), internalizing (5-items), and attention problems (5-items). It was developed as a caregiver-report measure for children ages 4 to 17; a youth self-report version is also available for youth 11 and up (the Y-PSC-17).
Measured: through study completion, an average of 7 months
Posttraumatic Stress Symptoms
Also to be entered in in the de-identified online dashboard, the Child and Adolescent Trauma Screen (CATS) will be used to assess post-traumatic stress symptoms for de-identified youth receiving CBT for Posttraumatic Stress (Trauma-focused CBT). This self-report measure assesses the frequency of PTSD symptoms and was also designed to assess PTSD diagnosis. The CATS has 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning.
Measured: through study completion, an average of 7 months
Depressive Symptoms
Also to be entered in the de-identified online dashboard, the Short Mood and Feelings Questionnaire (SMFQ) will be used to assess depression symptoms for de-identified clients receiving CBT for Depression. The SMFQ is a 13-item self-report questionnaire designed to measure core depressive symptomology in children and adolescents aged 6-17 years old. It assesses the presence of affective and cognitive symptoms of depression that have been experienced in the past 2 weeks. Items are rated on a 3-point Likert scale (not true = 0; sometimes true = 1; not true = 2).
Measured: through study completion, an average of 7 months
Anxiety Symptoms
Also to be entered into the de-identified online dashboard system, the Screen for Child Anxiety Related Emotional Disorders (SCARED) will be used to assess anxiety symptoms for de-identified clients receiving CBT for Anxiety. The SCARED is a 5-item, brief child-report measure that screens for common anxiety symptoms across anxiety disorders, for youth ages 8 to 17. Statements are rated on a 3-point Likert scale (0 = not true or hardly ever true, 2 = true or often true). scores 3 or higher suggested a positive screen for anxiety symptoms. The Initiative uses the brief version because it is more pragmatic.
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start22 Jul 2022
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Model description
- Aim 1a: The investigators will utilize Ideation to develop coaching strategies with supervisors. Aim 1b: The investigators will conduct an online experimental vignette study to gather preliminary evidence for how effectively different strategies emerging from Aim 1 impact our theorized mechanism (Implementation Climate-e.g., CBT use expected). Aim 1 activities are not part of the clinical trial (which starts with Aim 2 activities). Aim 2: The investigators will utilize a 2-arm randomized controlled trial to compare outcomes for anxiety, depression, PTSD, and behavioral problems for the group in the Implementation Coaching strategy optimized in Aim 1 and the Initiative's standard/as usual implementation. The groups will engage in the implementation support for 6 months and will complete a survey before and after the implementation support is terminated.
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Shannon Dorsey, University of Washington
- Investigators
- Shannon Dorsey, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799794
- Sponsor's protocol ID
- STUDY00014969
- Other IDs
- 1P50MH126219
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Implementation Coaching to Improve Treatment Quality and Client Outcomes in Community Mental Health Centers
- ClinicalTrials.gov ID
- NCT05799794
- Acronym / sponsor ID
- STUDY00014969
- Conditions
- Anxiety Depression, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 5 Apr 2023 (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 engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. The optimized coaching strategy has the potential to enhance the adoption and fidelity of evidence-based practice (EBP).
Detailed description
The Washington State EBP Initiative provides clinical training and consultation for Cognitive Behavioral Therapy (CBT) and some basic organizational support; however, consistent with the literature, community mental health centers (CMHCs) often need more to successfully implement CBT. To accelerate treatment quality and clinical outcomes for youth, CMHCs need practical strategies for "successfully implementing, sustaining, and improving" EBPs that can be tailored to fit their specific context. These strategies will have the greatest impact if designed and delivered by CMHC practice community members who have CMHC-specific EBP implementation experience and expertise.
Implementation facilitation, a multifaceted, dynamic strategy of interactive problem-solving and support, improves adoption and fidelity of interventions. Implementation facilitation may be a promising strategy for CMHCs, but the resources and demands of traditional facilitation may present challenges for CMHCs. Motivated by global mental health frugal innovations work, the Principal Investigator piloted a modified facilitation approach for CMHCs, Implementation Coaching (hereafter "Coaching"), delivered to CMHCs participating in the Initiative. Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The investigator led coaching, supporting supervisors in developing workplans for CBT implementation in their CMHCs across 3 implementation phases. Coaching recommends a limited set of implementation strategies in each phase (e.g., Implementation phase: local technical assistance) that address known, prioritized determinants. Supervisors are supported in tailoring strategies for their CMHCs. In the pilot, CMHCs that received Coaching had clinicians that engaged in CBT delivery earlier and with more youth. Qualitative interviews suggested that supervisors were engaged and found Coaching acceptable and feasible. Based on the pilots' success, Project 2 will engage CMHC supervisors in: a) co-designing an optimized version of Coaching, and b) leading Coaching for other supervisors to optimize CBT implementation in their CMHCs.
In this exploratory research project, the Investigators' goal is to extend a pilot study that included the development and implementation of Implementation Coaching (hereafter "Coaching") within the Washington State EBP Initiative. In the pilot, the Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The results of the pilot indicated that Coaching was acceptable and feasible. In the current study, in collaboration with CMHC supervisors, investigators aim to optimize and test the effectiveness of Coaching for improving CBT fidelity and youth outcomes for four common conditions in CMHCs. The hypothesized mechanism through which Coaching operates is implementation climate or the degree to which an organization expects, supports, and rewards an innovation. Investigators expect that Coaching can be most effective in supporting CMHCs' high-quality EBP implementation if optimized with the practice community (supervisors) for the goals of limited resource use, fit with CMHC workflow, and wider reach. Coaching reach can be improved by moving beyond delivery by University-based personnel. In the Initiative, peer CMHC supervisors with CBT experience and expertise already co-lead CBT clinical training.
The study includes the following aims: Aim 1a) Collaborating with CMHCs, investigators will identify and convene purposively sampled groups of supervisors for diverse perspectives and demographics (e.g., ethnically diverse supervisors/clientele; urban/rural) during 2 one-day, in-person Ideation workshops; Aim 1b) Up to 150 clinicians will be recruited through the Initiative listserv and CBT+ training (for clinicians who recently completed their training) to participate in an online study in which clinicians will be randomized to read up to 6 vignettes that describe different strategies developed in the ideation phase and complete a survey with relevant subscale/s of implementation climate (EBP use is expected, supported and rewarded); Aim 2) Clinicians will be randomly assigned to receive standard implementation support or standard implementation support plus Coaching by trained supervisors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aim 1a: The investigators will utilize Ideation to develop coaching strategies with supervisors. Aim 1b: The investigators will conduct an online experimental vignette study to gather preliminary evidence for how effectively different strategies emerging from Aim 1 impact our theorized mechanism (Implementation Climate-e.g., CBT use expected). Aim 1 activities are not part of the clinical trial (which starts with Aim 2 activities). Aim 2: The investigators will utilize a 2-arm randomized controlled trial to compare outcomes for anxiety, depression, PTSD, and behavioral problems for the group in the Implementation Coaching strategy optimized in Aim 1 and the Initiative's standard/as usual implementation. The groups will engage in the implementation support for 6 months and will complete a survey before and after the implementation support is terminated.
| Arm | Type | Receives |
|---|---|---|
| Standard/As Usual CBT+/EBP Initiative Implementation | Active comparator | Behavioral: Supervisor-led Implementation CoachingAll CMHCs involved in the CBT+/EBP Initiative receive virtual clinician training, CBT-phone consultation options over 6-months, access to a supervisor monthly call, listservs (one supervisor-focused), and a yearly advanced clinical training and supervisor training. The Initiative is a program that has been ongoing since 2009. |
| Supervisor-led Implementation Coaching | Experimental | Behavioral: Supervisor-led Implementation CoachingThe structure of this arm will depend on Aim 1. However, the investigators imagine that peer supervisors leading implementation coaching, trained in Aim 1, will have 3-5 virtual meetings with supervisors and email communication. Meetings focus on orientation to the theory and rationale for Coaching and supervisors' role as frontline leaders to support EBP implementation. Meetings are likely over 6 months and focus on different implementation phases. Coaches will support supervisors in developing tailored workplans for implementation in their CMHCs. In each meeting, the coach will review the strategies in the workplan, provide examples of how the strategy could be specified, and then facilitate discussion among supervisors. The coach will support supervisors in building a tailored workplan for their CMHC. Supervisors in the Coaching condition receive Coaching plus standard Initiative Implementation support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Supervisors in aim 1a and clinicians/supervisors in aim 2 must
Key exclusion criteria (3 listed)
- There is no exclusion criteria for supervisors in Aim 1a or clinicians in 1b.
- Supervisors who participate in Aim 1 will be excluded from participating in Aim 2 as recipients of Implementation Coaching.
- Supervisor coaches will be recruited from the supervisors that participated in Aim 2. There is no exclusion criteria for clinicians in Aim 2.
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 |
|---|---|---|
| Supervisor-led Implementation CoachingAlso: Facilitation; Implementation SupportImplementation coaching, support, or facilitation includes the support provided to supervisors and their organizations for successfully delivering an evidence-based practice (EBP). Implementation support can include consultation, supervision, and coaching. | Behavioural | Standard/As Usual CBT+/EBP Initiative Implementation, Supervisor-led Implementation Coaching |
Primary outcome
CBT Fidelity
Time frame: through study completion, an average of 7 months
Clinicians participating in the Initiative, and who participate in this study, routinely enter session and de-identified CBT client outcome data. The investigative team will code cases enrolled study clinicians enter into the de-identified Dashboard. Based on the CBT model the clinician specifies, investigators will code cases for delivery of "essential elements" of that CBT model for each of the mental health conditions of focus: Anxiety, Depression, Posttraumatic Stress, and Behavioral Problems. Essential element coding will produce a count and a "fidelity" ratio of sessions including essential CBT elements (vs. only other elements) for each client, specific to the CBT model they received. Higher scores represent higher CBT fidelity reflecting greater essential element delivery (content) and coverage (dose).
4 secondary outcomes
Externalizing Behavior Symptoms
Time frame: through study completion, an average of 7 months
Posttraumatic Stress Symptoms
Time frame: through study completion, an average of 7 months
Depressive Symptoms
Time frame: through study completion, an average of 7 months
Anxiety Symptoms
Time frame: through study completion, an average of 7 months
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 19 Feb 2025.
- Initiative's online dashboard systemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shannon Dorsey, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervisor-led Implementation Coaching in people with Anxiety Depression and Mental Health Issue, run by University of Washington 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 4 inclusion and 3 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 19 Feb 2025. 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?
CBT Fidelity (time frame: through study completion, an average of 7 months). 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 19 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.