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Completed

NCT Number: NCT04279028

Testing Different Modes of Cognitive Behavior Therapy

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Communication Literacy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

James W. Griffith

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • female
  • 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)
  • 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

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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).

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

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

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

Secondary outcomes

  1. 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)

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. 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)

    Time frame: 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)

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

    Time frame: 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)

  3. 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: CBT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2020
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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