Testing Different Modes of Cognitive Behavior Therapy

Not Applicable

Completed

• Conditions: Literacy; Depression
• Interventions: Behavioral: Standard CBT; Behavioral: Adapted CBT

• Registration Number: NCT04279028
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-14
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

1. 18 years of age or older
2. female
3. 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)
4. able and willing to give informed consent
5. able to communicate in English
6. willingness to be randomized to therapy
7. willing to complete all study assessments
8. at baseline, no plans to move from the Chicago area during the duration of the study

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Exclusion Criteria

1. history of bipolar disorder
2. history of psychosis
3. current substance use disorder of moderate or severe level of severity
4. suicidal intentions or actions within the past three months
5. known neurologic disease (e.g., multiple sclerosis, Parkinson's disease, cerebrovascular accident) and/or cognitive or neurologic impairment (e.g., Alzheimer's disease)
6. current participation in other psychotherapy (not including psychiatric appointments pertaining to medication management)
7. inadequate vision or hearing to interact with study materials
8. being a prisoner, detainee, or being in police custody
9. any current involvement in litigation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CBT	Standard CBT	Standard CBT, 12 sessions each lasting 45 minutes
Adapted CBT	Adapted CBT	Adapted CBT, 12 sessions each lasting 45 minutes

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 3-month follow-up (defined as 3 months after the end of treatment)	3-month follow up (i.e., 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.
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)	Post-treatment which is within 2 weeks after final therapy session (i.e. 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.

Trial Locations

Locations (1)

James W. Griffith; 🇺🇸 Chicago, Illinois, United States