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Testing Different Modes of Cognitive Behavior Therapy (CBT)

Primary Purpose

Depression, Literacy

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adapted CBT

Standard CBT

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

18 years of age or older
female
diagnosis of major depressive disorder (MDD) according to DSM-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 Chicagoland 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

Sites / Locations

James W. Griffith

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard CBT

Adapted CBT

Arm Description

Standard CBT, 12 sessions each lasting 45 minutes

Adapted CBT, 12 sessions each lasting 45 minutes

Outcomes

Primary Outcome Measures

PROMIS Depression: Post-treatment (defined as completing 12 therapy session)

Defined remission of MDD (partial or full) established by PROMIS.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04279028

First Posted

February 14, 2020

Last Updated

April 12, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04279028

Brief Title

Testing Different Modes of Cognitive Behavior Therapy

Acronym

CBT

Official Title

Testing Different Modes of Cognitive Behavior Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 14, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Literacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Participants are told they will receive one of two forms of CBT. They will not receive details about the other group. The outcomes assessor will have no information about group assignment.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard CBT

Arm Type

Active Comparator

Arm Description

Standard CBT, 12 sessions each lasting 45 minutes

Arm Title

Adapted CBT

Arm Type

Experimental

Arm Description

Adapted CBT, 12 sessions each lasting 45 minutes

Intervention Type

Behavioral

Intervention Name(s)

Adapted CBT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard CBT

Intervention Description

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.

Primary Outcome Measure Information:

Title

PROMIS Depression: Post-treatment (defined as completing 12 therapy session)

Description

Defined remission of MDD (partial or full) established by PROMIS.

Time Frame

Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Title

PROMIS Depression: : 3-month follow-up (defined as 3 months after the last (i.e., 12th) session of cognitive behavior therapy.

Description

Defined remission of MDD (partial or full) established by PROMIS.

Time Frame

3-month follow up (i.e., 3 months after the end of treatment)

Secondary Outcome Measure Information:

Title

Description

Time Frame

Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Title

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 3-month follow-up (defined as 3 months after the end of treatment)

Description

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.

Time Frame

3-month follow up (i.e., 3 months after the end of treatment)

Other Pre-specified Outcome Measures:

Title

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)

Description

Allows for the participant to indicate change in either direction (ie, much better, much worse)

Time Frame

Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Title

Patient Global Impression of Change (PGIC) 3-month follow-up (defined as 3 months after the end of treatment)

Description

Allows for the participant to indicate change in either direction (ie, much better, much worse)

Time Frame

3-month follow up (i.e., 3 months after the end of treatment)

Title

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)

Description

Measures four independent dimensions of the therapeutic relationship

Time Frame

Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older female diagnosis of major depressive disorder (MDD) according to DSM-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 Chicagoland 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

Facility Information:

Facility Name

James W. Griffith

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Testing Different Modes of Cognitive Behavior Therapy

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