Mild - Major Depression
Conditions
Brief summary
Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Detailed description
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
Linkoeping University
West University of Timisoara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be fluent in Romanian * be over 18 years * have a diagnosis of current major depression disorder * have access to an Internet connected computer
Exclusion criteria
* suicidal ideation * ongoing psychological treatment for depression * other primary disorder that need treatment * obstacle to participation (i.e., long travel plans) * recent change in psychiatric medication (i.e., during the last 6 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention) | 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. |
| Beck Depression Inventory II (BDI-II) | Absolute values (average score) of BDI-II at 37 weeks (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) | Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention) | 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. |
| Quality of Life Inventory (QOLI) | Absolute values (average score) of QOLI at 11 weeks (post-intervention) | 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. |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment) | 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. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 19 |
| Wait List Control Group (WLCG) This arm represents the wait-list comparison group. | 26 |
| Total | 79 |
Baseline characteristics
| Characteristic | Religious CBT (R-CBT) | Wait List Control Group (WLCG) | Conventional-CBT (C-CBT) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 26 Participants | 34 Participants | 79 Participants |
| Age, Continuous | 32.21 years STANDARD_DEVIATION 11.66 | 35.65 years STANDARD_DEVIATION 9.15 | 29.21 years STANDARD_DEVIATION 8.88 | 32.05 years STANDARD_DEVIATION 9.97 |
| Region of Enrollment Romania | 19 participants | 26 participants | 34 participants | 79 participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 30 Participants | 65 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 34 | 19 / 19 | 26 / 26 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Absolute values (average score) of BDI-II at 37 weeks (follow-up)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Beck Depression Inventory II (BDI-II) | 15.20 units on a scale | Standard Deviation 13.11 |
| Religious CBT (R-CBT) | Beck Depression Inventory II (BDI-II) | 13.56 units on a scale | Standard Deviation 12.49 |
p-value: <0.01t-test, 1 sided
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.
Time frame: Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Beck Depression Inventory-II (BDI-II) | 11.45 units on a scale | Standard Deviation 10.46 |
| Religious CBT (R-CBT) | Beck Depression Inventory-II (BDI-II) | 12.43 units on a scale | Standard Deviation 15.04 |
| Wait List Control Group (WLCG) | Beck Depression Inventory-II (BDI-II) | 26.02 units on a scale | Standard Deviation 8.74 |
Comparison: It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.p-value: <0.001ANOVA
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.
Time frame: Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Beck Anxiety Inventory (BAI) | 24.72 units on a scale | Standard Deviation 13.6 |
| Religious CBT (R-CBT) | Beck Anxiety Inventory (BAI) | 22.62 units on a scale | Standard Deviation 13.9 |
| Wait List Control Group (WLCG) | Beck Anxiety Inventory (BAI) | 27.27 units on a scale | Standard Deviation 12.33 |
p-value: >0.05ANOVA
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.
Time frame: Absolute values (average score) of QOLI at 11 weeks (post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Quality of Life Inventory (QOLI) | .74 units on a scale | Standard Deviation 2.03 |
| Religious CBT (R-CBT) | Quality of Life Inventory (QOLI) | .39 units on a scale | Standard Deviation 1.62 |
| Wait List Control Group (WLCG) | Quality of Life Inventory (QOLI) | -.92 units on a scale | Standard Deviation 1.79 |
p-value: <0.01ANOVA
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.
Time frame: Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional-CBT (C-CBT) | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 10.47 units on a scale | Standard Deviation 5.69 |
| Religious CBT (R-CBT) | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 10.27 units on a scale | Standard Deviation 6.17 |
| Wait List Control Group (WLCG) | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 14.90 units on a scale | Standard Deviation 4.24 |
p-value: <0.001ANOVA