Mild - Major DepressionPsiTODNCT02091856
Internet-delivered Psychotherapy for Depression
A study testing Cognitive Behavioral Therapy (CBT) in people with Mild - Major Depression, run by West University of Timisoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild - Major Depression
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- be fluent in Romanian
- be over 18 years
- have a diagnosis of current major depression disorder
- have access to an Internet connected computer
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Read the 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.
- Conditions
- Mild - Major Depression
- Being tested
- Cognitive Behavioral Therapy (CBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Wait List Control Group (WLCG) | No intervention | This arm represents the wait-list comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Absolute values (average score) of BDI-II at 37 weeks (follow-up)
Secondary outcomes (3)
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.
Measured: Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)
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.
Measured: 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.
Measured: Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: We have recruited and treated 79 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild - Major DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Bogdan Tudor Tulbure, PhD, Principal investigator, West University of Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091856
- Sponsor's protocol ID
- WUTimisoara-PsiTOD
- Acronym
- PsiTOD
- Status last verified
- Feb 2016
- First submitted
- 5 Mar 2014
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
- ClinicalTrials.gov ID
- NCT02091856
- Acronym / sponsor ID
- PsiTOD / WUTimisoara-PsiTOD
- Conditions
- Mild - Major Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have recruited and treated 79 participants
- Enrolment
- 79 participants (actual)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional-CBT (C-CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (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. |
| Religious CBT (R-CBT) | Experimental | Behavioral: Cognitive Behavioral Therapy (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. |
| Wait List Control Group (WLCG) | No intervention | –This arm represents the wait-list comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be fluent in Romanian
- be over 18 years
- have a diagnosis of current major depression disorder
- have access to an Internet connected computer
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| 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. | Behavioural | Conventional-CBT (C-CBT), Religious CBT (R-CBT) |
Primary outcome
Beck Depression Inventory-II (BDI-II)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)
Quality of Life Inventory (QOLI)
Time frame: Absolute values (average score) of QOLI at 11 weeks (post-intervention)
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time frame: Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Public pages describing the PsiTOD project (in Romanian)Link provided by the sponsor.
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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.
Bogdan Tudor Tulbure, PhD principal investigator
West University of Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Mild - Major Depression, run by West University of Timisoara at 1 site in Romania.
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: stopped early, as of the sponsor's last update on 28 Jun 2018. 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 Romania. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-II (BDI-II) (time frame: Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)). The study lists 2 primary outcomes in all. 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 28 Jun 2018.