Testing Different Modes of Cognitive Behavior Therapy (CBT)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Literacy
• Intervention / Treatment: Behavioral: Standard CBT; Behavioral: Adapted CBT

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • James W. Griffith

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard CBT; Standard CBT, 12 sessions each lasting 45 minutes	Behavioral: Standard CBT; 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.
Experimental: Adapted CBT; Adapted CBT, 12 sessions each lasting 45 minutes	Behavioral: Adapted CBT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC): Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview)	Allows for the participant to indicate change in either direction (ie, much better, much worse)	Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)
Patient Global Impression of Change (PGIC) 3-month follow-up (defined as 3 months after the end of treatment)	Allows for the participant to indicate change in either direction (ie, much better, much worse)	3-month follow up (i.e., 3 months after the end of treatment)
California Psychotherapy Alliance Scale - Participant version short-form - Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview)	Measures four independent dimensions of the therapeutic relationship	Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STU00210885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No