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Innovative Methods to Assess Psychotherapy Practices (imAPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479398
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Shannon Wiltsey Stirman, Palo Alto Veterans Institute for Research

Brief Summary:
This project compares two methods of assessing the quality of cognitive behavioral therapy (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in clinical notes, and 2) rating the quality of worksheets that are completed with therapist guidance during sessions. It also examines whether ratings of worksheets completed on a mobile app are reliable and valid quality measures. This information can inform strategies to monitor and enhance CBT quality, which can ultimately improve the quality of care and clinical outcomes.

Condition or disease Intervention/treatment
Mobile Application-Based CBT Worksheet Collection Paper-Based Worksheet Collection Behavioral: Cognitive Behavioral Therapy

Detailed Description:
Cognitive Behavioral Therapy (CBT) has been demonstrated to be effective for numerous presenting problems, including depression, anxiety, and post-traumatic stress disorder (PTSD). Several large mental health systems have invested heavily in programs to train their clinicians in CBTs, but relatively little attention has been devoted to the monitoring or promotion of CBT quality after training is complete. Identifying strategies to do so can facilitate research and training, and is critical to ensuring consumer access to high quality, evidence-based treatments. The lack of a scalable, effective, and efficient method of monitoring quality is a key barrier to efforts to promote high-quality implementation. Self-report fidelity assessments increase clinician and consumer burden and may not accurately reflect clinician skill or the intensity with which CBT interventions are delivered. Observation and expert ratings are time and resource intensive and unlikely to be feasible or affordable in large systems. To maximize the likelihood of broad implementation once effective strategies to monitor quality are established, it is essential that these strategies are feasible and acceptable in routine care contexts, leveraging information collected during routine care. To date, few monitoring strategies that do not involve observation, client/caregiver reports, or clinician self-reports have been tested. To address this critical implementation challenge, we propose to refine and evaluate a method of monitoring quality that is based on an evaluation of CBT worksheets that are completed in session. Because the worksheets were developed to implement core cognitive and behavioral elements and are embedded in CBTs across diagnostic categories, they may be used to elucidate the clinician's ability to guide the client through CBT interventions in session. Preliminary research with this measure demonstrated high correlations between the measure and observer ratings of clinician competence, associations with subsequent symptom change, and high agreement between raters with differing levels of familiarity with CBT. Completion of the ratings based on worksheets requires only a small fraction of time required for session observation and ratings. This project will compare this novel strategy to observer ratings and adherence checklists that are embedded in clinical notes. Furthermore, it will compare the accuracy of worksheet data collected by mobile app to paper-form worksheets, and assess the feasibility and acceptability of these strategies. Because the core elements of CBT and its worksheets are common across many CBTs, this research has broad implications for monitoring fidelity to CBTs in a variety of mental health and healthcare systems and settings. This research will be conducted by a team of investigators with expertise in CBT, training, implementation, psychotherapy process and outcome research, psychometrics, longitudinal data analysis, mobile technologies and healthcare economics, with input from community partners and end-users. The resulting products have the potential to significantly improve efforts to monitor and ensure ongoing high quality implementation of CBT in routine care settings.

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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Group/Cohort Intervention/treatment
App Condition
Although we will be mostly observing routine practice, we will randomize patients into either an App condition or paper condition. The App condition refers to patients completing routine Cognitive Behavioral Therapy (CBT) worksheets on a mobile application during session. Everything else that occurs in treatment sessions will be consistent with routine care practices.
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based psychotherapy that treats a variety of disorders. In this study, clinicians will be enrolled who use types of CBT for anxiety disorders, depression and PTSD in their routine clinical practice. CBT is usually a 12-16 session treatment that focuses on intervening on disorders cognitively and behaviorally through the use of worksheets during session and outside of session.
Other Name: Cognitive Processing Therapy

Paper Condition
Although we will be mostly observing routine practice, we do randomize patients into either an App condition or paper condition. The paper condition refers to patients completing routine CBT worksheets on paper (the current standard) during session.
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is an evidence-based psychotherapy that treats a variety of disorders. In this study, clinicians will be enrolled who use types of CBT for anxiety disorders, depression and PTSD in their routine clinical practice. CBT is usually a 12-16 session treatment that focuses on intervening on disorders cognitively and behaviorally through the use of worksheets during session and outside of session.
Other Name: Cognitive Processing Therapy




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks ]
    9-item self-report measure of depression symptoms with good internal reliability (α = .89) and test-retest reliability (r = .84).

  2. Change in Posttraumatic Stress Disorder Checklist (PCL-5) [ Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks ]
    A 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual (DSM-5) symptoms of PTSD. Good internal consistency and concurrent validity with the Clinician-assessed PTSD Scale.

  3. Change in Beck Anxiety Inventory [ Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks ]
    21-item self-report instrument for measuring the severity of anxiety symptoms. Good internal consistency (α = .92) and high test-retest reliability (r = .75.).


Secondary Outcome Measures :
  1. Change in Inventory of Psycho social Functioning-Brief Version [ Time Frame: Completed at baseline, 4th session and post-treatment (week 16) ]
    14 items, yields a grand mean and 7 subscale means for functioning in romance, family, friendships, parenting, education, work, and self-care activities (non-applicable categories can be skipped; total score reflects mean of applicable items). Excellent reliability and internal consistency ( α = 0.93); correlates with other measures of quality of life.

  2. Evidence-Based Practice Attitudes Scale-50 (EBPAS) [ Time Frame: Completed at therapist baseline (prior to providing treatment in the study) ]
    This measure looks at Evidence-based practice attitudes and motivation among clinicians, 1 (worse)-5 (best) total score range

  3. Perceived Characteristics of Interventions (PCIS) [ Time Frame: Completed at therapist baseline (prior to providing treatment in the study) ]
    Innovation characteristics hypothesized to influence adoption and sustainability

  4. Implementation Climate Assessment (ICA) [ Time Frame: Completed at therapist baseline (prior to providing treatment in the study) ]
    Brief validated measure of implementation climate ( manager support for EBPs, etc.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Therapists who provide Cognitive Behavioral Therapy, and their patients who receive CBT for depression, anxiety, or PTSD. Therapists and patients will be recruited from community-based, public mental health (e.g., Boston and Palo Alto VA) and private practice treatment settings.
Criteria

Inclusion Criteria:

A. Clinician eligibility:

  • Private practice or employment at an agency at which the administration agrees to allow the recruitment and participation of their providers in research related activities
  • English Speaking
  • No anticipated plans to leave their current agency for at least 18 months
  • Willingness to allow their CBT sessions, worksheets, surveys, and interview data, and clinical notes to be used for research purposes
  • Carry a caseload that typically includes patients who experience depression, anxiety, or PTSD, with whom they regularly conduct individual therapy sessions and/or capacity to increase the proportion of such patients (e.g., clinic sees a substantial number of individuals with PTSD or depression)
  • Must be trained (worksheet or web-based training and consultation) or in training for Cognitive Processing Therapy (CPT) for PTSD or CBT for depression or anxiety that uses worksheets Does not include CBT-i Can include aspects (i.e., worksheets) of CBT for substance use as long as depression or anxiety is primary diagnoses
  • Must anticipate at least 3 eligible patients
  • Must be willing to record sessions and provide worksheets and symptom measures to the study
  • Must have computer and internet access
  • Must be willing to use a mobile app on a tablet or mobile device

B. Patient eligibility:

  • Must be 18 yrs. of age or older
  • Experience one or more of the following (both a diagnosis and cut off score):

Clinician diagnosis of primary PTSD (PTSD-Checklist-5 score of 33 or more) Depressive disorder (e.g., major depressive disorder, dysthymia; PHQ of 10 or above) Or an Anxiety Disorder (Beck Anxiety Disorder score of 22 or above)

  • Note that if a patient has a score close to the cut-off score, it's up to the therapist digression

    • Must be willing to allow the team to collect session recordings, measures, notes and worksheets
    • Must be able to read and write at a sixth-grade level or above
    • Able to participate in sessions conducted in English, or Spanish (if working with bilingual clinicians in community or private practice)
    • Must be willing to engage in CBT/CPT
    • Therapist considers the treatment with the individual patient to be "mostly" CBT or CPT

Cannot have*:

- Imminent risk of suicide or homicide (requiring hospitalization) that require immediate treatment In need of detoxification (can be enrolled when substance abuse treatment is not the primary treatment target) Active psychosis or manic episode unless well controlled by medication and not the primary focus of treatment Cognitive impairments that preclude any participation in therapy

C. Administrator eligibility:

  • Must have a support or managerial/supervisory position at the clinic(s) from which A and B are being recruited from
  • Must also be willing to complete a packet of study measures/partake in an interview

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479398


Contacts
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Contact: Shannon W Stirman, PhD 6504935000 ext 20007 sws1@stanford.edu
Contact: Heidi La Bash, PhD 650-614-9997 ext 20610 Heidi.LaBash@va.gov

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Shannon Wiltsey-Stirman, Ph.D.    650-493-5000 ext 20007    SHANNON.WILTSEY-STIRMAN@VA.GOV   
Principal Investigator: Shannon Wiltsey-Stirman, PhD         
United States, Massachusetts
NCPTSD - VA Boston HCS Recruiting
Boston, Massachusetts, United States, 02130
Contact: Caroline Canale, B.A.    857-364-3206    Caroline.Canale@va.gov   
Principal Investigator: Cassidy Gutner, PhD         
Massachusetts General Hospital Recruiting
Chelsea, Massachusetts, United States, 02150
Contact: Kaylie Patrick, MPH    617-887-4063      
Principal Investigator: Luana Marques, PhD         
United States, Pennsylvania
Aaron T. Beck Psychopathology Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nicholas Affrunti, PhD    215-573-0209    naff@pennmedicine.upenn.edu   
Principal Investigator: Torrey Creed, PhD         
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
National Institute of Mental Health (NIMH)

Publications:
Carroll KM, Martino S, Rounsaville BJ. No train, no gain? Clinical Psychology: Science and Practice. 2010;17(1):36-40.
Resick PA, Monson CM, Chard KM. Cognitive processing therapy veteran/military version: Therapist and patient materials manual. . Washington, DC: Department of Veterans' Affairs; 2008.
Foa EB, Keane TM, Friedman MJ, Cohen JA. Effective treatments for PTSD: Practice guidelines from the International Society for Traumatic Stress Studies (2nd ed.). New York, NY US: Guilford Press; 2009.
Beck AT, Steer RA. Manual for the Beck anxiety inventory. 1990.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shannon Wiltsey Stirman, Psychologist/Implementation Scientist, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03479398    
Other Study ID Numbers: WIS0003AGG
R01MH112628 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannon Wiltsey Stirman, Palo Alto Veterans Institute for Research:
Fidelity
Cognitive Behavioral Therapy
Mobile Application
Routine Practice