Testing Different Modes of Cognitive Behavior Therapy

NCT04279028 | Completed

• 1 other identifier: STU00210885
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Literacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

• 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)

Other Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Standard CBT

ACTIVE COMPARATOR

Standard CBT, 12 sessions each lasting 45 minutes

Behavioral: Standard CBT

Adapted CBT

EXPERIMENTAL

Adapted CBT, 12 sessions each lasting 45 minutes

Behavioral: Adapted CBT

Interventions

Adapted CBT BEHAVIORAL

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.

Adapted CBT

Standard CBT BEHAVIORAL

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.

Standard CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

James W. Griffith

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression; Literacy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Communication

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical Social Sciences

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 20, 2020
• Study Start: February 14, 2020
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)