Cognitive Behavioral Therapy

Develop Your Framework Assignment
This assignment involves creating a starting proposal template for both the development and pilot-testing of an enhanced cognitive behavioral therapy (CBT) intervention for treatment-resistant depression. The proposal outline follows.
Proposal Template/Outline
Section 1: Basic Information
1.1 Study Title
1.2 Is this Study Exempt from Federal Regulations?
1.3 Exemption Number
1.4 Clinical Trial Questionnaire
1.5 Provide the ClinicalTrials.gov Identifier (e.g. NCT87654321) for this trial, if applicable.
Section 2: Study Population Characteristics
2.1 Conditions or Focus of Study
Background/Rationale
The proposed study specifically involves the design of a 12-week manualized CBT protocol which will integrate cognitive control training exercises for patients with depression who are resistant to treatment. Furthermore, the study will involve performing a randomized controlled trial to compare this novel CBT intervention to more traditional CBT treatment, evaluating changes in several measures, including symptoms of depression, cognitive functioning, and quality of life. According to the National Institute of Mental Health (NIMH, 2023), one area that represents a top priority within mental health research is treatment-resistant depression. There is a definite need to investigate evidence-based treatment interventions, including novel options, which can improve health outcomes for those diagnosed with treatment-resistant depression (NIMH, 2023).
2.2 Eligibility Criteria
2.3 Age Limits
2.3.a Inclusion of Individuals Across the Lifespan
2.4 Inclusion of Women and Minorities
2.5 Recruitment and Retention Plan
2.6 Recruitment Status
2.7 Study Timeline
2.8 Enrollment of First Participant
2.9 Inclusion Enrollment Report(s)
Section 3: Protection and Monitoring Plans
3.1 Protection of Human Subjects
3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
3.3 Data and Safety Monitoring Plan
3.4 Will a Data and Safety Monitoring Board be appointed for this study?
3.5 Overall Structure of the Study Team
Section 4: Protocol Synopsis
4.1 Study Design
The chosen methodology for this study will be quantitative, with numerical data collected and analyzed. Specifically, the research design that will be used is experimental, conducting a randomized controlled trial to examine the newly designed CBT intervention with cognitive control training modules. This enhanced CBT protocol will be compared to CBT interventions that do not integrate these cognitive control training modules, which will be referred to as Treatment As Usual (TAU).
Procedure
This research study will be performed over a period of two years, with three separate phases. Phase 1: Protocol Development will be between months one and six, with a comprehensive literature review undertaken. During this phase, experts in CBT as well as cognitive neuroscience will also be consulted, enabling the enhanced CBT manual and training materials to be developed and refined.
Phase 2: Randomized Controlled Trial will be between months 7 and 18, with 100 human participants recruited. These participants will be voluntary patients who have been diagnosed with treatment-resistant depression. They will be randomly assigned to two groups: a) a treatment (experimental) group with 50 participants who will receive the enhanced CBT protocol, and b) a control group with 50 participants who will receive TAU (traditional CBT protocol). Baseline assessments will be performed, after which participants will engage in therapy sessions each week. After completion of these sessions, post-treatment assessments will be undertaken, with follow-up at three-months post-intervention.
Phase 3: Data Analysis and Dissemination will be between months 19 and 24, where collected data compiled during the randomized controlled trial will be analyzed. During this phase, manuscripts will also be prepared for peer-reviewed journals. Finally, materials will be developed for clinical training workshops.
4.2 Outcome Measures
The randomized controlled trial will include one primary outcome that will be measured: changes in depressive symptoms. The primary outcome will be measured using the Hamilton Depression Rating Scale, with improvement noted with a significant reduction in symptoms of depression. Additionally, two secondary outcomes will be measured: changes in cognitive functioning and changes in quality of life. Changes in cognitive functioning will be measured through cognitive control tasks, comparing the treatment group’s performance to the control group. The expected outcomes are for significant improvements in the treatment group’s cognitive control tasks and functional outcomes. Changes in quality of life will be measured using quality of life scores, with better scores anticipated for the treatment group compared to the control group. Finally, treatment adherence and patient satisfaction ratings will also be evaluated.
4.3 Statistical Design and Power
4.4 Subject Participation Duration
4.5 Will the study use an FDA-regulated intervention?
4.6 Is this an applicable clinical trial under FDAAA?
4.7 Dissemination Plan
Section 5: Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments

Checklist of Supporting Documents
• Letters of commitment from all collaborators, explaining their contributions to the study
• Cover Letter
• PHS Assignment Request Form
• Bibliography & References Cited
• Facilities & Other Resources
• Equipment
• Letters of Support
• Consortium/Contractual Arrangements
• Protection of Human Subjects Statement
Due Date for Review Cycle
The NIH (2023) explains that all grant applications along with associated documents must be turned in by 5:00 PM local time on the specified due date for the applicant organization. For new Research Grants (R01), February 5 is the due date for Cycle I, June 5 is the due date for Cycle II, and October 5 is the due date for Cycle III. As for the Review Cycle, Application due dates are January 25 to May 7 (Cycle I), May 25 to September 7 (Cycle II), and September 25 to January 7 (Cycle III). For the Scientific Merit Review, the due dates are June to July (Cycle I), October to November, (Cycle II), and February to March (Cycle III). For the Advisory Council Round, the due dates are August or October (Cycle I), January (Cycle II), and May (Cycle III). Finally, the Earliest Project Start Date due dates are September of December (Cycle I), April (Cycle II), and July (Cycle III).
Submission Process
The submission process for NIH offers several options for applicants, including the university’s submission system, Grants.gov Workspace system, and even the organization’s own ASSIST web-based application submission system.