CBT: Testing Different Modes of Cognitive Behavior Therapy

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04279028

Collaborator

(none)

Enrollment

Location

Arms

42.5

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Literacy	Behavioral: Adapted CBT Behavioral: Standard CBT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

Testing Different Modes of Cognitive Behavior Therapy

Actual Study Start Date :

Feb 14, 2020

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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

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.
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.

Other Outcome Measures

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) [Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)]
Allows for the participant to indicate change in either direction (ie, much better, much worse)
Patient Global Impression of Change (PGIC) 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)]
Allows for the participant to indicate change in either direction (ie, much better, much worse)
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) [Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)]
Measures four independent dimensions of the therapeutic relationship

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James W. Griffith	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James W Griffith, Associate Professor of Medical Social Sciences, Northwestern University

ClinicalTrials.gov Identifier:

NCT04279028

Other Study ID Numbers:

STU00210885

First Posted:

Feb 20, 2020

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Jun 22, 2022