Clinical trial NCT03479398: Innovative Methods to Assess Psychotherapy Practices (imAPP)
Official title: Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mobile Application-Based CBT Worksheet Collection
Paper-Based Worksheet Collection
Keywords: Fidelity
Cognitive Behavioral Therapy
Mobile Application
Routine Practice
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-03-27
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
measure: Change in Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
measure: Change in Beck Anxiety Inventory
timeFrame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Secondary outcomes:
measure: Change in Inventory of Psycho social Functioning-Brief Version
timeFrame: Completed at baseline, One Month, and post-treatment (week 16)
measure: Evidence-Based Practice Attitudes Scale-50 (EBPAS)
timeFrame: Completed at therapist baseline (prior to providing treatment in the study)
measure: Perceived Characteristics of Interventions (PCIS)
timeFrame: Completed at therapist baseline (prior to providing treatment in the study)
measure: Implementation Climate Assessment (ICA)
timeFrame: Completed at therapist baseline (prior to providing treatment in the study)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Boston
country: United States
facility: NCPTSD - VA Boston HCS
state: Massachusetts
city: Chelsea
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Aaron T. Beck Psychopathology Research Center
state: Pennsylvania
Study officials:
affiliation: NCPTSD/Stanford University
name: Shannon W Stirman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHugh RK, Barlow DH. The dissemination and implementation of evidence-based psychological treatments. A review of current efforts. Am Psychol. 2010 Feb-Mar;65(2):73-84. doi: 10.1037/a0018121.
citation: Schoenwald SK. It's a Bird, It's A Plane, It's ... Fidelity Measurement In the Real World. Clin Psychol (New York). 2011 Jun;18(2):142-147. doi: 10.1111/j.1468-2850.2011.01245.x.
citation: Schoenwald SK, Garland AF, Chapman JE, Frazier SL, Sheidow AJ, Southam-Gerow MA. Toward the effective and efficient measurement of implementation fidelity. Adm Policy Ment Health. 2011 Jan;38(1):32-43. doi: 10.1007/s10488-010-0321-0.
citation: Ruzek JI, Rosen RC. Disseminating evidence-based treatments for PTSD in organizational settings: A high priority focus area. Behav Res Ther. 2009 Nov;47(11):980-9. doi: 10.1016/j.brat.2009.07.008. Epub 2009 Jul 26.
citation: Carroll KM, Martino S, Rounsaville BJ. No train, no gain? Clinical Psychology: Science and Practice. 2010;17(1):36-40.
citation: Decker SE, Jameson MT, Naugle AE. Therapist training in empirically supported treatments: a review of evaluation methods for short- and long-term outcomes. Adm Policy Ment Health. 2011 Jul;38(4):254-86. doi: 10.1007/s10488-011-0360-1.
citation: Resick PA, Galovski TE, Uhlmansiek MO, Scher CD, Clum GA, Young-Xu Y. A randomized clinical trial to dismantle components of cognitive processing therapy for posttraumatic stress disorder in female victims of interpersonal violence. J Consult Clin Psychol. 2008 Apr;76(2):243-258. doi: 10.1037/0022-006X.76.2.243.
citation: Resick PA, Monson CM, Chard KM. Cognitive processing therapy veteran/military version: Therapist and patient materials manual. . Washington, DC: Department of Veterans' Affairs; 2008.
citation: Beck AT. The current state of cognitive therapy: a 40-year retrospective. Arch Gen Psychiatry. 2005 Sep;62(9):953-9. doi: 10.1001/archpsyc.62.9.953.
citation: Clark DM. Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. Int Rev Psychiatry. 2011 Aug;23(4):318-27. doi: 10.3109/09540261.2011.606803.
citation: Karlin BE, Cross G. From the laboratory to the therapy room: National dissemination and implementation of evidence-based psychotherapies in the U.S. Department of Veterans Affairs Health Care System. Am Psychol. 2014 Jan;69(1):19-33. doi: 10.1037/a0033888. Epub 2013 Sep 2.
citation: Karlin BE, Ruzek JI, Chard KM, Eftekhari A, Monson CM, Hembree EA, Resick PA, Foa EB. Dissemination of evidence-based psychological treatments for posttraumatic stress disorder in the Veterans Health Administration. J Trauma Stress. 2010 Dec;23(6):663-73. doi: 10.1002/jts.20588. Epub 2010 Nov 15.
citation: 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.
citation: Stirman SW, Buchhofer R, McLaulin JB, Evans AC, Beck AT. Public-academic partnerships: the Beck Initiative: a partnership to implement cognitive therapy in a community behavioral health system. Psychiatr Serv. 2009 Oct;60(10):1302-4. doi: 10.1176/ps.2009.60.10.1302.
citation: Mendel P, Meredith LS, Schoenbaum M, Sherbourne CD, Wells KB. Interventions in organizational and community context: a framework for building evidence on dissemination and implementation in health services research. Adm Policy Ment Health. 2008 Mar;35(1-2):21-37. doi: 10.1007/s10488-007-0144-9. Epub 2007 Nov 8.
citation: Chambers DA, Glasgow RE, Stange KC. The dynamic sustainability framework: addressing the paradox of sustainment amid ongoing change. Implement Sci. 2013 Oct 2;8:117. doi: 10.1186/1748-5908-8-117.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Beck AT, Steer RA. Manual for the Beck anxiety inventory. 1990.
citation: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
citation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
citation: Wiltsey Stirman S, Marques L, Creed TA, Gutner CA, DeRubeis R, Barnett PG, Kuhn E, Suvak M, Owen J, Vogt D, Jo B, Schoenwald S, Johnson C, Mallard K, Beristianos M, La Bash H. Leveraging routine clinical materials and mobile technology to assess CBT fidelity: the Innovative Methods to Assess Psychotherapy Practices (imAPP) study. Implement Sci. 2018 May 22;13(1):69. doi: 10.1186/s13012-018-0756-3.