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We have recruited and treated 79 participants
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Previous studies suggest that incorporating religious beliefs into conventional CBT appears to be helpful for religious individuals. In order to have two active comparable interventions the investigators added to the conventional CBT a similar set of exercises devised from the positive psychology paradigm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Experimental | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm. |
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| Religious CBT (R-CBT) | Experimental | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief. |
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| Wait List Control Group (WLCG) | No Intervention | This arm represents the wait-list comparison group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the post-intervention assessment. | Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention) |
| Beck Depression Inventory II (BDI-II) | The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the measure of depression at 6 month after the intervention. | Absolute values (average score) of BDI-II at 37 weeks (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety. This represent the post-intervention assessment. | Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan Tudor Tulbure, PhD | West University of Timisoara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West University of Timisoara | Timișoara | Timiș County | 300223 | Romania |
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| Label | URL |
|---|---|
| Public pages describing the PsiTOD project (in Romanian) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional-CBT (C-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm. |
| FG001 | Religious CBT (R-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. |
| FG002 | Wait List Control Group (WLCG) | This arm represents the wait-list comparison group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Intervention Interval |
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| Follow-up Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional-CBT (C-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beck Depression Inventory-II (BDI-II) | The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the post-intervention assessment. | Posted | Mean | Standard Deviation | units on a scale | Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention) |
|
Other Adverse Events (depression levels) were collected weekly through study completion (an average of 11 weeks).
Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that major depression or dysthymia represents Other Adverse Events that occurred in all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional-CBT (C-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major depression disorder (MDD) or dysthymia | Psychiatric disorders | Systematic Assessment | Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that MDD or dysthimia represents Other Adverse Events that occurred in all participants |
1) A high drop out rate at post-test & follow-up. 2) The outcome assessments were not fully blind. 3) Participants in C-CBT & R-CBT were self-selected based on their religiousness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bogdan Tudor Tulbure | West University of Timisoara | +040745753061 | btulbure@gmail.com |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Quality of Life Inventory (QOLI) | The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality. This represents the post-intervention assessment. | Absolute values (average score) of QOLI at 11 weeks (post-intervention) |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents a secondary outcome measure for depression taken immediately after the intervention. | Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment) |
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| NOT COMPLETED |
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| BG001 | Religious CBT (R-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. |
| BG002 | Wait List Control Group (WLCG) | This arm represents the wait-list comparison group. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Religious CBT (R-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. |
| OG002 | Wait List Control Group (WLCG) | This arm represents the wait-list comparison group. |
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| Secondary | Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety. This represent the post-intervention assessment. | Posted | Mean | Standard Deviation | units on a scale | Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention) |
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| Secondary | Quality of Life Inventory (QOLI) | The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality. This represents the post-intervention assessment. | Posted | Mean | Standard Deviation | units on a scale | Absolute values (average score) of QOLI at 11 weeks (post-intervention) |
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| Secondary | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents a secondary outcome measure for depression taken immediately after the intervention. | Posted | Mean | Standard Deviation | units on a scale | Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment) |
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| Primary | Beck Depression Inventory II (BDI-II) | The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents the measure of depression at 6 month after the intervention. | Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up. | Posted | Mean | Standard Deviation | units on a scale | Absolute values (average score) of BDI-II at 37 weeks (follow-up) |
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| 34 |
| 34 |
| EG001 | Religious CBT (R-CBT) | This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief. Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief. | 0 | 0 | 19 | 19 |
| EG002 | Wait List Control Group (WLCG) | This arm represents the wait-list comparison group. | 0 | 0 | 26 | 26 |
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