Mobile Application-Based CBT Worksheet CollectionNCT03479398
Innovative Methods to Assess Psychotherapy Practices (imAPP)
An observational study of Mobile Application-Based CBT Worksheet Collection and Paper-Based Worksheet Collection, run by Palo Alto Veterans Institute for Research at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobile Application-Based CBT Worksheet Collection, Paper-Based Worksheet Collection
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 439 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2017to 15 Oct 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 26Show fewer
- 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
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NCPTSD - VA Boston HCS
Boston, Massachusetts, 02130
Massachusetts General Hospital
Chelsea, Massachusetts, 02150
VA Palo Alto Health Care System
Palo Alto, California, 94304
Aaron T. Beck Psychopathology Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality
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.
Read the 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.
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Fidelity, Cognitive Behavioral Therapy, Mobile Application, Routine Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called Cognitive Processing 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-9)
9-item self-report measure of depression symptoms with good internal reliability (α = .89) and test-retest reliability (r = .84).
Measured: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
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.
Measured: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Change in Beck Anxiety Inventory
21-item self-report instrument for measuring the severity of anxiety symptoms. Good internal consistency (α = .92) and high test-retest reliability (r = .75.).
Measured: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks
Secondary outcomes (4)
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 ( α = 0.93); correlates with other measures of quality of life.
Measured: Completed at baseline, One Month, and post-treatment (week 16)
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
Measured: Completed at therapist baseline (prior to providing treatment in the study)
Perceived Characteristics of Interventions (PCIS)
Innovation characteristics hypothesized to influence adoption and sustainability
Measured: Completed at therapist baseline (prior to providing treatment in the study)
Implementation Climate Assessment (ICA)
Brief validated measure of implementation climate ( manager support for EBPs, etc.)
Measured: Completed at therapist baseline (prior to providing treatment in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Apr 2017
- Primary completion15 Dec 2021
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Mobile Application-Based CBT Worksheet CollectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Shannon Wiltsey Stirman, Palo Alto Veterans Institute for Research
- Investigators
- Shannon W Stirman, PhD, Principal investigator, NCPTSD/Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479398
- Sponsor's protocol ID
- WIS0003AGG
- Other IDs
- R01MH112628
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20141263Schoenwald 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.
PubMed 21691439Schoenwald 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.
PubMed 20957425Ruzek 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.
PubMed 19632668Carroll 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.
PubMed 21656256Resick 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.
PubMed 18377121Resick 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.
PubMed 16143727Clark 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.
PubMed 22026487Karlin 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.
PubMed 24001035Karlin 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.
PubMed 21171126Foa 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.
PubMed 19797367Mendel 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.
PubMed 17990095
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Routine Clinical Materials and Mobile Technology to Assess CBT Quality
- ClinicalTrials.gov ID
- NCT03479398
- Acronym / sponsor ID
- WIS0003AGG
- Keywords
- Fidelity, Cognitive Behavioral Therapy, Mobile Application, Routine Practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 27 Mar 2018 (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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Condition | – | Behavioral: Cognitive Behavioral TherapyAlthough 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. |
| Paper Condition | – | Behavioral: Cognitive Behavioral TherapyAlthough 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Cognitive Processing TherapyCognitive 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. | Behavioural | App Condition, Paper Condition |
Primary outcome
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).
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.
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.).
4 secondary outcomes
Change in Inventory of Psycho social Functioning-Brief Version
Time frame: Completed at baseline, One Month, and post-treatment (week 16)
Evidence-Based Practice Attitudes Scale-50 (EBPAS)
Time frame: Completed at therapist baseline (prior to providing treatment in the study)
Perceived Characteristics of Interventions (PCIS)
Time frame: Completed at therapist baseline (prior to providing treatment in the study)
Implementation Climate Assessment (ICA)
Time frame: Completed at therapist baseline (prior to providing treatment in the study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 20141263McHugh 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.
- Background: PubMed 21691439Schoenwald 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.
- Background: PubMed 20957425Schoenwald 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.
- Background: PubMed 19632668Ruzek 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.
- BackgroundCarroll KM, Martino S, Rounsaville BJ. No train, no gain? Clinical Psychology: Science and Practice. 2010;17(1):36-40.
- Background: PubMed 21656256Decker 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.
- Background: PubMed 18377121Resick 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.
- BackgroundResick PA, Monson CM, Chard KM. Cognitive processing therapy veteran/military version: Therapist and patient materials manual. . Washington, DC: Department of Veterans' Affairs; 2008.
- Background: PubMed 16143727Beck 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.
- Background: PubMed 22026487Clark 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.
- Background: PubMed 24001035Karlin 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.
- Background: PubMed 21171126Karlin 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.
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 W Stirman, PhD principal investigator
NCPTSD/Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mobile Application-Based CBT Worksheet Collection and Paper-Based Worksheet Collection, run by Palo Alto Veterans Institute for Research at 4 sites 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 26 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Change in Patient Health Questionnaire (PHQ-9) (time frame: Baseline (pre-treatment), Every session (weekly) if primary /target problem up to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479398, which also lists 22 linked publications.
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 3 Nov 2022.