Major Depressive DisorderNCT02837887
Computerized Cognitive Behavior Therapy in Treating Depression in Patients With Cancer
A study testing Computerized Cognitive Behavior Therapy in people with Major Depressive Disorder, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Computerized Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2016to 29 Mar 2018
- 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
- A current/prior cancer diagnosis
- A principal diagnosis of major depressive disorder (MDD)
- Able and willing to give informed consent
- Have access to a computer with an internet connection at home
Who cannot join
- History of bipolar affective disorder or psychosis
- History of substance dependence in the past six months
- Subnormal intellectual potential (intelligence quotient [IQ] below 80)
- Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
- Inability to read and write English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.
II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).
III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.
After completion of study intervention, patients are followed up at 2, 4, and 6 months.
- Conditions
- Major Depressive Disorder
- Being tested
- Computerized Cognitive Behavior Therapy
- Keywords
- Cancer, Depression
- Medical subject headings
- Depressive Disorder, Major, Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Behavior TherapyBehavioural
Also called cCBT, cognitive behavior therapy, Beating the Blues, CBT
Undergo computerized cognitive behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| Group I (immediate treatment) | Experimental | Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the PHQ-9 and GAD7 at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms. Receives: Behavioral: Computerized Cognitive Behavior Therapy |
| Group II (wait-list) | Experimental | Patients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I. Receives: Behavioral: Computerized Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression (HRSD)
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
Measured: Week 0 to Week 8
Secondary outcomes (3)
Change in the Beck Depression Inventory (BDI-II)
The PHQ9 is a 9-item self-report measure based on the diagnostic criteria for major depression from the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: Week 0 to week 8
Change in Patient Health Questionnaire-9 (PHQ-9)
21 item self report measures of depressive symptoms
Measured: Week 0 to week 8
Change in Generalized Anxiety Disorder-7 (GAD7)
The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV.
Measured: Week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start15 Jul 2016
- Primary completion31 Dec 2017
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Andersen, Ohio State University Comprehensive Cancer Center
- Investigators
- Barbara Andersen, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837887
- Sponsor's protocol ID
- OSU-16008
- Other IDs
- NCI-2016-00954
- Status last verified
- Jun 2020
- First submitted
- 13 Jul 2016
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerized Cognitive Behavioral Therapy for Cancer Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02837887
- Acronym / sponsor ID
- OSU-16008
- Conditions
- Major Depressive Disorder
- Keywords
- Cancer, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
This randomized clinical trial studies how well a computerized cognitive behavior therapy program works in treating depression in patients with cancer. The cognitive behavior therapy program uses a series of internet-delivered sessions intended to help patients identify and change problematic patterns of thinking and behavior that maintain depression.
Detailed description
PRIMARY OBJECTIVES:
- Establish the efficacy of computerized cognitive behavior therapy ("Beating the Blues") in reducing symptoms of depression and remission of major depressive disorder (MDD) in cancer patients.
II. Test the feasibility of implementation and patient acceptability of online computerized cognitive behavior therapy for cancer patients with major depressive disorder (MDD).
III. Test moderators (cancer specific stress, MDD history, anxiety disorder comorbidity, and homework compliance) of treatment outcome.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (IMMEDIATE TREATMENT): Patients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD7) at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms.
GROUP II (WAIT-LIST): Patients are placed on an 8-week wait-list and then undergo computerized behavior therapy and receive questionnaires as in Group I.
After completion of study intervention, patients are followed up at 2, 4, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (immediate treatment) | Experimental | Behavioral: Computerized Cognitive Behavior TherapyPatients undergo computerized cognitive behavior therapy consisting of 45-60 minute sessions once per week for 8 weeks. Patients also complete the PHQ-9 and GAD7 at weeks 1, 3, 5, 7 and 8 and complete other questionnaires for 15-30 minutes each that assess psychosocial and physical symptoms. |
| Group II (wait-list) | Experimental | Behavioral: Computerized Cognitive Behavior TherapyPatients are placed on an 8-week wait-list and then undergo computerized cognitive behavior therapy and receive questionnaires as in Group I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A current/prior cancer diagnosis
- A principal diagnosis of major depressive disorder (MDD)
- Able and willing to give informed consent
- Have access to a computer with an internet connection at home
Key exclusion criteria (5 listed)
- History of bipolar affective disorder or psychosis
- History of substance dependence in the past six months
- Subnormal intellectual potential (intelligence quotient [IQ] below 80)
- Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
- Inability to read and write English
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 |
|---|---|---|
| Computerized Cognitive Behavior TherapyAlso: cCBT, cognitive behavior therapy, Beating the Blues, CBTUndergo computerized cognitive behavior therapy | Behavioural | Group I (immediate treatment), Group II (wait-list) |
Primary outcome
Change in Hamilton Rating Scale for Depression (HRSD)
Time frame: Week 0 to Week 8
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
3 secondary outcomes
Change in the Beck Depression Inventory (BDI-II)
Time frame: Week 0 to week 8
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 0 to week 8
Change in Generalized Anxiety Disorder-7 (GAD7)
Time frame: Week 0 to week 8
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 22 Jun 2020.
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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.
Barbara Andersen, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Behavior Therapy in people with Major Depressive Disorder, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 5 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 22 Jun 2020. 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 Hamilton Rating Scale for Depression (HRSD) (time frame: Week 0 to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2020.