Innovative Methods to Assess Psychotherapy Practices (imAPP)

Mobile Application-Based CBT Worksheet Collection Clinical Trial

Official title:

Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03479398
• Other study ID #: WIS0003AGG
• Secondary ID: R01MH112628
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2022
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 439
• Est. completion date: October 15, 2023
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobile Application-Based CBT Worksheet Collection
• Paper-Based Worksheet Collection

Intervention

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.

Locations

Country	Name	City	State
United States	NCPTSD - VA Boston HCS	Boston	Massachusetts
United States	Massachusetts General Hospital	Chelsea	Massachusetts
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Aaron T. Beck Psychopathology Research Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

Beck AT, Steer RA. Manual for the Beck anxiety inventory. 1990.

Beck AT. The current state of cognitive therapy: a 40-year retrospective. Arch Gen Psychiatry. 2005 Sep;62(9):953-9. Review. — View 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. — View Citation

Carroll KM, Martino S, Rounsaville BJ. No train, no gain? Clinical Psychology: Science and Practice. 2010;17(1):36-40.

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. — View 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. Review. — View 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. Review. — View 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.

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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2007 Nov 8. — View 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. — View 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.

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. Review. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire (PHQ-9)	9-item self-report measure of depression symptoms with good internal reliability (a = .89) and test-retest reliability (r = .84).	Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Primary	Change in Posttraumatic Stress Disorder Checklist (PCL-5)	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.	Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Primary	Change in Beck Anxiety Inventory	21-item self-report instrument for measuring the severity of anxiety symptoms. Good internal consistency (a = .92) and high test-retest reliability (r = .75.).	Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Secondary	Change in Inventory of Psycho social Functioning-Brief Version	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 ( a = 0.93); correlates with other measures of quality of life.	Completed at baseline, One Month, and post-treatment (week 16)
Secondary	Evidence-Based Practice Attitudes Scale-50 (EBPAS)	This measure looks at Evidence-based practice attitudes and motivation among clinicians, 1 (worse)-5 (best) total score range	Completed at therapist baseline (prior to providing treatment in the study)
Secondary	Perceived Characteristics of Interventions (PCIS)	Innovation characteristics hypothesized to influence adoption and sustainability	Completed at therapist baseline (prior to providing treatment in the study)
Secondary	Implementation Climate Assessment (ICA)	Brief validated measure of implementation climate ( manager support for EBPs, etc.)	Completed at therapist baseline (prior to providing treatment in the study)