Major DepressionNCT01208428
Cognitive Behavioral Treatments for Depression in Chronic Illness
A study testing Conventional cognitive behavioral therapy and Religious cognitive behavioral therapy in people with Major Depression, run by Duke University at 2 sites in United States.
Trial summary
Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Conventional cognitive behavioral therapy and Religious cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Aug 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic disabling medical illness
- religion at least somewhat important to patient
- major depressive disorder by MINI neuropsychiatric interview
- Beck Depression Inventory scores of 16-28 (moderately severe depression)
- live near Durham, North Carolina, or near Glendale, in Southern California
Who cannot join
- significant cognitive impairment
- significant suicidal thoughts or risk
- no access to telephone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Glendale Adventist Medical Center
Glendale, California, 91201
About this study
Official title: Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness
Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Therapists will deliver the treatment in real time over the Internet and/or by telephone to increase treatment access. This planning grant seeks support for a two-site study (North Carolina and California) that consists of two phases. In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and RCBT.
In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions.
The purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. The importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. If 65% of Americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.
- Conditions
- Major Depression
- Being tested
- Conventional cognitive behavioral therapy, Religious cognitive behavioral therapy
- Keywords
- Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cognitive behavioral therapyBehavioural
Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.
Religious cognitive behavioral therapyBehavioural
Religious cognitive behavioral therapy is conventional cognitive behavioral therapy that includes consideration of the patient's religious beliefs in therapy. Subjects will receive ten 50-min sessions of therapy
| Study group | Role | What they receive |
|---|---|---|
| Conventional cognitive behavioral therapy | Active comparator | Subjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression Receives: Behavioral: Conventional cognitive behavioral therapy |
| Religious cognitive behavioral therapy | Experimental | Subjects randomized to this arm will receive conventional cognitive behavioral therapy, but their religious beliefs will be utilized as a resource in the therapy Receives: Behavioral: Religious cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Quantitative assessment of depressive symptoms
Measured: Baseline
Beck Depression Inventory
Quantitative assessment of depressive symptoms
Measured: 4 weeks
Beck Depression Inventory
Quantitative assessment of depressive symptoms
Measured: 8 weeks
Beck Depression Inventory
Quantitative assessment of depressive symptoms
Measured: 12 weeks
Beck Depression Inventory
Quantitative assessment of depressive symptoms
Measured: 24 weeks
Secondary outcomes (3)
Duke Social Support Index (abbreviated)
Measures amount of social support and satisfaction with it.
Measured: Baseline
Duke Social Support Index (abbreviated)
Measures amount of social support and satisfaction with it
Measured: 12 weeks
Duke Social Support Index
Measures amount of social support and satisfaction with it.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Duke 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold G Koenig, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208428
- Sponsor's protocol ID
- Pro00026533
- Status last verified
- Mar 2015
- First submitted
- 22 Sep 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Propst LR, Ostrom R, Watkins P, Dean T, Mashburn D. Comparative efficacy of religious and nonreligious cognitive-behavioral therapy for the treatment of clinical depression in religious individuals. J Consult Clin Psychol. 1992 Feb;60(1):94-103. doi: 10.1037//0022-006x.60.1.94.
PubMed 1556292Koenig HG. Religion and remission of depression in medical inpatients with heart failure/pulmonary disease. J Nerv Ment Dis. 2007 May;195(5):389-95. doi: 10.1097/NMD.0b013e31802f58e3.
PubMed 17502804Koenig HG, George LK, Peterson BL. Religiosity and remission of depression in medically ill older patients. Am J Psychiatry. 1998 Apr;155(4):536-42. doi: 10.1176/ajp.155.4.536.
PubMed 9546001
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Treatments for Depression in Patients With Chronic Illness
- ClinicalTrials.gov ID
- NCT01208428
- Acronym / sponsor ID
- Pro00026533
- Conditions
- Major Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Sep 2010 (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.
Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Therapists will deliver the treatment in real time over the Internet and/or by telephone to increase treatment access. This planning grant seeks support for a two-site study (North Carolina and California) that consists of two phases. In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and RCBT.
In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions.
The purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. The importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. If 65% of Americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional cognitive behavioral therapy | Active comparator | Behavioral: Conventional cognitive behavioral therapySubjects randomized to this arm will receive conventional cognitive behavioral therapy for the treatment of major depression |
| Religious cognitive behavioral therapy | Experimental | Behavioral: Religious cognitive behavioral therapySubjects randomized to this arm will receive conventional cognitive behavioral therapy, but their religious beliefs will be utilized as a resource in the therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic disabling medical illness
- religion at least somewhat important to patient
- major depressive disorder by MINI neuropsychiatric interview
- Beck Depression Inventory scores of 16-28 (moderately severe depression)
- live near Durham, North Carolina, or near Glendale, in Southern California
Key exclusion criteria (3 listed)
- significant cognitive impairment
- significant suicidal thoughts or risk
- no access to telephone
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 |
|---|---|---|
| Conventional cognitive behavioral therapyConventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered. | Behavioural | Conventional cognitive behavioral therapy |
| Religious cognitive behavioral therapyReligious cognitive behavioral therapy is conventional cognitive behavioral therapy that includes consideration of the patient's religious beliefs in therapy. Subjects will receive ten 50-min sessions of therapy | Behavioural | Religious cognitive behavioral therapy |
Primary outcome
Beck Depression Inventory
Time frame: Baseline
Quantitative assessment of depressive symptoms
Beck Depression Inventory
Time frame: 4 weeks
Quantitative assessment of depressive symptoms
Beck Depression Inventory
Time frame: 8 weeks
Quantitative assessment of depressive symptoms
Beck Depression Inventory
Time frame: 12 weeks
Quantitative assessment of depressive symptoms
Beck Depression Inventory
Time frame: 24 weeks
Quantitative assessment of depressive symptoms
3 secondary outcomes
Duke Social Support Index (abbreviated)
Time frame: Baseline
Duke Social Support Index (abbreviated)
Time frame: 12 weeks
Duke Social Support Index
Time frame: 24 weeks
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 17 Mar 2015.
- Background: PubMed 1556292Propst LR, Ostrom R, Watkins P, Dean T, Mashburn D. Comparative efficacy of religious and nonreligious cognitive-behavioral therapy for the treatment of clinical depression in religious individuals. J Consult Clin Psychol. 1992 Feb;60(1):94-103. doi: 10.1037//0022-006x.60.1.94.
- Background: PubMed 17502804Koenig HG. Religion and remission of depression in medical inpatients with heart failure/pulmonary disease. J Nerv Ment Dis. 2007 May;195(5):389-95. doi: 10.1097/NMD.0b013e31802f58e3.
- Background: PubMed 9546001Koenig HG, George LK, Peterson BL. Religiosity and remission of depression in medically ill older patients. Am J Psychiatry. 1998 Apr;155(4):536-42. doi: 10.1176/ajp.155.4.536.
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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.
Harold G Koenig, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cognitive behavioral therapy and Religious cognitive behavioral therapy in people with Major Depression, run by Duke University at 2 sites 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 3 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Beck Depression Inventory (time frame: Baseline). The study lists 5 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 NCT01208428, which also lists 3 linked publications.
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 17 Mar 2015.