Testing Different Modes of Cognitive Behavior Therapy

Study Overview
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Brief Summary
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The purpose of this study is to test a novel behavioral treatment - Adapted Cognitive-Behavior Therapy (ACBT) - against standard Cognitive Behavior Therapy (CBT). The goal of the study is to determine if ACBT confers improved outcomes for women with depression and low literacy. Depression is a serious women's health issue. According to the World Health Organization, depression is the leading cause of disability worldwide with females reporting symptoms of depression at almost twice the rate of males. This study will provide pilot data to enable us to determine the effect size needed to detect a between-groups change in depression scores. The overall impact of this study will be empirical support for a novel form of treatment for women with depression, who also may lack adequate literacy, educational, or cognitive ability required to benefit from standard CBT.

Official Title
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Testing Different Modes of Cognitive Behavior Therapy

Conditions
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Depression, Literacy

Intervention / Treatment
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* Behavioral: Adapted CBT
* Behavioral: Standard CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older female diagnosis of major depressive disorder (MDD) according to DSM-5 (Diagnostic and Statistical Manual-5) (and no specifiers that pertain to exclusionary criteria (e.g. MDD with psychotic features) able and willing to give informed consent able to communicate in English willingness to be randomized to therapy willing to complete all study assessments at baseline, no plans to move from the Chicago area during the duration of the study Exclusion Criteria: history of bipolar disorder history of psychosis current substance use disorder of moderate or severe level of severity suicidal intentions or actions within the past three months known neurologic disease (e.g., multiple sclerosis, Parkinson's disease, cerebrovascular accident) and/or cognitive or neurologic impairment (e.g., Alzheimer's disease) current participation in other psychotherapy (not including psychiatric appointments pertaining to medication management) inadequate vision or hearing to interact with study materials being a prisoner, detainee, or being in police custody any current involvement in litigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard CBT<br>Standard CBT, 12 sessions each lasting 45 minutes | Behavioral: Standard CBT<br>* CBT involves the therapist and client working to identify and change negative beliefs and thoughts, replacing them with more accurate and balanced thoughts. CBT for Depression will be conducted according to standard manuals and incorporate the use of a common workbook used within CBT sessions. As per standard practice, participants will be assigned worksheets from their workbook used both in session and as homework assignments.<br>|
| Experimental: Adapted CBT<br>Adapted CBT, 12 sessions each lasting 45 minutes | Behavioral: Adapted CBT<br>* ACBT is derived from traditional CBT principles, but eliminates the text-heavy requirements. Traditional CBT incorporates the use of complex worksheets and a lengthy workbook, whereas ACBT replaces these skill learning activities with simpler, straightforward exercises that are practiced in session along with the therapist. This real world practice eliminates the need for reading and writing as part of CBT while simultaneously recapitulating how the patient would actually implement CBT procedures. In session exercises will mirror that of standard CBT practices. For example, they could include lessons in goal setting, distinguishing situations, moods, and thoughts, and experiments to test underlying assumptions. Participants will be assigned paper-free homework assignments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Depression: Post-treatment (defined as completing 12 therapy session) | Defined remission of MDD (partial or full) established by PROMIS (Patient-Reported Outcomes Measurement Information System). | Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview) | 
| PROMIS Depression: : 3-month follow-up (defined as 3 months after the last (i.e., 12th) session of cognitive behavior therapy. | Defined remission of MDD (partial or full) established by PROMIS. | 3-month follow up (i.e., 3 months after the end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview) | The 12-item WHODAS 2.0 is a measure of functional impairment. Higher scores indicate a higher level of impairment. The scores for each item range from 0-4; the WHO scoring algorithm converts the summed score to a 0-100% score. The post-treatment score will be compared to baseline to quantify reduction of impairment after treatment. | Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview) | 
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 3-month follow-up (defined as 3 months after the end of treatment) | The 12-item WHODAS 2.0 is a measure of functional impairment. Higher scores indicate a higher level of impairment. The scores for each item range from 0-4; the WHO scoring algorithm converts the summed score to a 0-100% score. The 3-month follow-up score will be compared to baseline to quantify reduction of impairment after treatment. | 3-month follow up (i.e., 3 months after the end of treatment) |