- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479398
Innovative Methods to Assess Psychotherapy Practices (imAPP)
Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
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Massachusetts
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Boston, Massachusetts, United States, 02130
- NCPTSD - VA Boston HCS
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Chelsea, Massachusetts, United States, 02150
- Massachusetts General Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Aaron T. Beck Psychopathology Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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9-item self-report measure of depression symptoms with good internal reliability (α = .89)
and test-retest reliability (r = .84).
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Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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Change in Posttraumatic Stress Disorder Checklist (PCL-5)
Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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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.
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Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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Change in Beck Anxiety Inventory
Time Frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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21-item self-report instrument for measuring the severity of anxiety symptoms.
Good internal consistency (α = .92)
and high test-retest reliability (r = .75.).
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Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Inventory of Psycho social Functioning-Brief Version
Time Frame: Completed at baseline, One Month, and post-treatment (week 16)
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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.
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Completed at baseline, One Month, and post-treatment (week 16)
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Evidence-Based Practice Attitudes Scale-50 (EBPAS)
Time Frame: Completed at therapist baseline (prior to providing treatment in the study)
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This measure looks at Evidence-based practice attitudes and motivation among clinicians, 1 (worse)-5 (best) total score range
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Completed at therapist baseline (prior to providing treatment in the study)
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Perceived Characteristics of Interventions (PCIS)
Time Frame: Completed at therapist baseline (prior to providing treatment in the study)
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Innovation characteristics hypothesized to influence adoption and sustainability
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Completed at therapist baseline (prior to providing treatment in the study)
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Implementation Climate Assessment (ICA)
Time Frame: Completed at therapist baseline (prior to providing treatment in the study)
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Brief validated measure of implementation climate ( manager support for EBPs, etc.)
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Completed at therapist baseline (prior to providing treatment in the study)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shannon W Stirman, PhD, NCPTSD/Stanford University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Carroll KM, Martino S, Rounsaville BJ. No train, no gain? Clinical Psychology: Science and Practice. 2010;17(1):36-40.
- 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.
- 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.
- Resick PA, Monson CM, Chard KM. Cognitive processing therapy veteran/military version: Therapist and patient materials manual. . Washington, DC: Department of Veterans' Affairs; 2008.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Beck AT, Steer RA. Manual for the Beck anxiety inventory. 1990.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WIS0003AGG
- R01MH112628 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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