Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

A study testing Psychotherapy in people with Depression, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Psychotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2020to 19 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

current or past diagnosis of bipolar disorder or a psychotic disorder;
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);
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;
currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders;
clear indication of secondary gain (e.g., court-ordered treatment); and
current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Psychology, The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Conditions: Depression
Being tested: Psychotherapy
Keywords: Cognitive Behavioral Therapy, Depression, Randomized Clinical Trial, Cognitive Behavioral Skills
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PsychotherapyOther
In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.

Study groups in NCT04673513
Study group	Role	What they receive
Cognitive Behavioral Therapy (CBT)	Active comparator	Cognitive behavioral therapy will be provided as described in Beck et al. (1979) and Beck (2011), with adaptations for the treatment of comorbid personality disorders as described in Beck et al. (2015). Receives: Other: Psychotherapy
Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)	Active comparator	This condition includes a variation of CBT (as provided in the other condition) with special emphasis on helping clients to develop the skills of CBT. Receives: Other: Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.
The Quick Inventory of Depressive Symptoms-Self-Report is a 16-item self-report measure of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Measured: Weeks 0-12, assessments occurred at every session through week 12.
Change in Cognitive Change Sustained at week 12.
The Cognitive Change Sustained is a 9-item measure designed to assess the degree to which experienced cognitive change and used cognitive and behavioral strategies in the days leading up to their session. Scores range from 0 to 54, with a higher score indicating greater cognitive change.
Measured: Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.
Change in Ways of Responding Scale at week 12.
The Ways of Responding Scale is a measure of the skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with a higher score indicating greater CBT skills.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in CBT Skills - Interview at week 12.
The CBT skills interview is a semi-structured interview based measure of CBT skills. Assessors evaluate the clients CBT skills use over the past two weeks with seven items. This interview assesses client skills in using coping strategies central to CBT. Scores range from 0 to 28, with a higher score indicating greater CBT skills.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.

Secondary outcomes (5)

Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.
The Quick Inventory of Depressive Symptoms-Clinician version is a 16-item measure of depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Cognitive Change Immediate at week 12.
The Cognitive Change Sustained is a 5-item measure of the extent to which the client adopted new perspectives in session. It is completed following each session. Scores range from 0 to 30, with a higher score indicating greater cognitive change.
Measured: Weeks 0-12, assessments occurred at every session through week 12.
Change in Competencies of Cognitive Therapy Scale - client version at week 12.
The Competencies of Cognitive Therapy Scale - client version is a 29-item self-report scale that measures three areas in which clients are expected to acquire competencies from participating in CBT: behavioral activation, coping with automatic thoughts, and knowledge of schemas or core beliefs. Scores range from 29 to 203, with a higher score indicating greater CBT skills.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.
The Competencies of Cognitive Therapy Scale - therapist version is a 9-item self-report scale measures three areas in which clients are expected to acquire competencies from participating in CBT: behavioral activation, coping with automatic thoughts, and knowledge of schemas or core beliefs. Scores range from 0 to 54, with a higher score indicating greater CBT skills.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Work Social Adjustment Scale at week 12.
The Work Social Adjustment Scale is a 5-item self-report measure of functioning. Items assess the extent to which the client's functioning is impaired with regard to the client's ability to work, manage problems at home, participate in social and private leisure activities, and form close relationships. Scores range from 0 to 40, with a higher score indicating greater impairment.
Measured: Weeks 0-12, assessments occurred at intake, week 4, and week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 202019 Apr 2023

First posted17 Dec 2020
Study start11 Dec 2020
Primary completion8 Nov 2022
Study completion19 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04673513
Sponsor's protocol ID: 2020B0354
Status last verified: Apr 2024
First submitted: 12 Dec 2020
Last updated: 18 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We will consider requests for data sharing, pending approval from our IRB.

Publications

Beck AT, Rush AJ, Shaw BF, Emery G. (1979). Cognitive Therapy of Depression. Guilford.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills
ClinicalTrials.gov ID: NCT04673513
Acronym / sponsor ID: 2020B0354
Conditions: Depression
Keywords: Cognitive Behavioral Therapy, Depression, Randomized Clinical Trial, Cognitive Behavioral Skills
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: 11 Dec 2020 (actual)
Primary completion: 8 Nov 2022 (actual)
Study completion: 19 Apr 2023 (actual)
First posted: 17 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cognitive Behavioral Therapy (CBT)	Active comparator	Other: PsychotherapyCognitive behavioral therapy will be provided as described in Beck et al. (1979) and Beck (2011), with adaptations for the treatment of comorbid personality disorders as described in Beck et al. (2015).
Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)	Active comparator	Other: PsychotherapyThis condition includes a variation of CBT (as provided in the other condition) with special emphasis on helping clients to develop the skills of CBT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

current or past diagnosis of bipolar disorder or a psychotic disorder;
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);
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;
currently participating in a treatment for an emotional disorder, including any individual psychotherapy or psychiatric medications used to treat a mood or anxiety disorders;
clear indication of secondary gain (e.g., court-ordered treatment); and

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PsychotherapyIn light of COVID-19 considerations, interventions are currently being provided via telehealth technology.	Other	Cognitive Behavioral Therapy (CBT), Cognitive Behavioral Therapy - Skill enhanced (CBT-SE)

Primary outcome

Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12.
Time frame: Weeks 0-12, assessments occurred at every session through week 12.
The Quick Inventory of Depressive Symptoms-Self-Report is a 16-item self-report measure of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.
Change in Cognitive Change Sustained at week 12.
Time frame: Weeks 0-12, assessments occurred at every session aside from session 1 through week 12.
The Cognitive Change Sustained is a 9-item measure designed to assess the degree to which experienced cognitive change and used cognitive and behavioral strategies in the days leading up to their session. Scores range from 0 to 54, with a higher score indicating greater cognitive change.
Change in Ways of Responding Scale at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
The Ways of Responding Scale is a measure of the skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with a higher score indicating greater CBT skills.
Change in CBT Skills - Interview at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
The CBT skills interview is a semi-structured interview based measure of CBT skills. Assessors evaluate the clients CBT skills use over the past two weeks with seven items. This interview assesses client skills in using coping strategies central to CBT. Scores range from 0 to 28, with a higher score indicating greater CBT skills.

5 secondary outcomes

Change in Quick Inventory of Depressive Symptoms-Clinician version at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Cognitive Change Immediate at week 12.
Time frame: Weeks 0-12, assessments occurred at every session through week 12.
Change in Competencies of Cognitive Therapy Scale - client version at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Competencies of Cognitive Therapy Scale - therapist version at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.
Change in Work Social Adjustment Scale at week 12.
Time frame: Weeks 0-12, assessments occurred at intake, week 4, and week 12.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
BackgroundBeck AT, Rush AJ, Shaw BF, Emery G. (1979). Cognitive Therapy of Depression. Guilford.
Individual participant dataSharing planned: No. We will consider requests for data sharing, pending approval from our IRB.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel R Strunk, PhD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Psychotherapy in people with Depression, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quick Inventory of Depressive Symptoms-Self-Report at week 12. (time frame: Weeks 0-12, assessments occurred at every session through week 12.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673513, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.