Clinical trial NCT04279028: Testing Different Modes of Cognitive Behavior Therapy
Official title: Testing Different Modes of Cognitive Behavior Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Literacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Depression: Post-treatment (defined as completing 12 therapy session)
timeFrame: Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)
measure: PROMIS Depression: : 3-month follow-up (defined as 3 months after the last (i.e., 12th) session of cognitive behavior therapy.
timeFrame: 3-month follow up (i.e., 3 months after the end of treatment)
Secondary outcomes:
measure: 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)
timeFrame: Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 3-month follow-up (defined as 3 months after the end of treatment)
timeFrame: 3-month follow up (i.e., 3 months after the end of treatment)
Other outcomes:
measure: 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)
timeFrame: Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)
measure: Patient Global Impression of Change (PGIC) 3-month follow-up (defined as 3 months after the end of treatment)
timeFrame: 3-month follow up (i.e., 3 months after the end of treatment)
measure: 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)
timeFrame: Post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)
Locations:
city: Chicago
country: United States
facility: James W. Griffith
state: Illinois
Study officials:
References: