Clinical trial NCT04673513: Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
Official title: Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Cognitive Behavioral Therapy
Depression
Randomized Clinical Trial
Cognitive Behavioral Skills
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two psychological treatments for major depressive disorder (MDD): cognitive-behavioral therapy (CBT) and CBT-Skill Enhanced (CBT-SE). CBT is well-studied, research-supported treatment for depression. CBT-SE is a variant of CBT that places greater focus on helping clients to developing the skills of CBT.

The study will enroll 150 participants with MDD. Participants will be randomized to CBT or CBT-SE, with 75 participants being assigned to each condition. For both conditions, treatment will be provided over 12 weeks, with a 6 month follow-up period.

Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. After entering the study, participants are asked to complete evaluations at 4 weeks and at 12 weeks. They are also asked to respond to self-report instruments before and after each session. Following the 12 week treatment, participants are asked to complete monthly follow-up surveys for 6 months.

The primary objectives of this study are three-fold. The first is to compare the outcomes of the two treatments. The second is to evaluate potential mediators of any treatment differences. The third is to evaluate the process of change in these two versions of CBT.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of major depressive disorder (MDD) according to DSM-5 criteria;
2. 18 years old or older;
3. residence in the state of Ohio;
4. access to a reliable internet connection (to participate in virtual sessions); and
5. being able and willing to give informed consent.

Exclusion Criteria:

1. current or past diagnosis of bipolar disorder or a psychotic disorder;
2. moderate or severe substance use in the past 6 months (where "moderate" is defined as 4-5 symptoms and "severe" is defined as 6 + symptoms of those listed in DSM-5 for each of the substance-related disorders);
3. current disorder other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered;
4. currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders;
5. clear indication of secondary gain (e.g., court-ordered treatment); and
6. current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.

Primary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.
timeFrame: Weeks 0-12, assessments occurred at every session through week 12.
measure: Change in Cognitive Change Sustained at week 12.
timeFrame: Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.
measure: Change in Ways of Responding Scale at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
measure: Change in CBT Skills - Interview at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
measure: Change in Cognitive Change Immediate at week 12.
timeFrame: Weeks 0-12, assessments occurred at every session through week 12.
measure: Change in Competencies of Cognitive Therapy Scale - client version at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
measure: Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
measure: Change in Work Social Adjustment Scale at week 12.
timeFrame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Other outcomes:
measure: Time to relapse per modified version of the Patient Health Questionnaire
timeFrame: Immediately post-treatment to 6 months post treatment. Assessments occurred monthly following the posttreatment evaluation
Locations:
city: Columbus
country: United States
facility: Department of Psychology, The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Daniel R Strunk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck AT, Rush AJ, Shaw BF, Emery G. (1979). Cognitive Therapy of Depression. Guilford.