DepressioniRFCBTNCT03507114
Rumination Focus Cognitive Behavior Therapy
A study testing Rumination-Focused CBT (RFCBT) in people with Depression and Dysthymic Disorder, run by West University of Timisoara at 1 site in Romania.
Trial summary
1. To investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (WLCG). 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Dysthymic Disorder, Panic Disorder
- What is being tested?
- Rumination-Focused CBT (RFCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRomania
- Study dates
- 27 Mar 2018to 27 Feb 2019
- 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
- be fluent in Romanian,
- be at least 18 years of age,
- display elevated levels of worry and/or rumination (e.g., at least one self-report score above the following cut-offs: Penn State Worry Questionnaire Total score > 50 and/or Rumination Response Scale - Brooding sub-scale ≥ 10)
- have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, and/or panic disorder, or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I)
Who cannot join
- suicidal plans,
- changes in the dosage if psychotropic medication during the last month (if present),
- have bipolar disorder or psychosis (according to medication status)
- have an alcohol/substance abuse and/or dependence disorder
- currently take part in other psychological treatment,
- obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.);
- have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder
Trial locations and contacts
1 site in 1 country.
Edward Watkins, PhD contact
Romania1 site, 1 recruiting
- Recruiting
West University of Timisoara
Timișoara, Timiș County, 300223
Bogdan Tudor Tulbure, PhD, 0040745753061, btulbure@gmail.com
About this study
Official title: An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
- To investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (WLCG).
- To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.
Read the detailed description
The effectiveness of a Rumination Focused Cognitive-Behavioral Treatment (RF-CBT) will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach was design to specifically target repetitive negative thinking (e.g., rumination and worries). Specifically, the treatment involves first a functional analysis design to help participants identify when rumination starts, distinguish between helpful versus unhelpful repetitive thinking, and learn more functional responses, and experiential and imagery exercises design to help them shift their thought processing towards concreteness, absorption and compassion. The main goal of the study is to test the effectiveness of this transdiagnostic approach in reducing symptom of depression and anxiety.
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder
- Being tested
- Rumination-Focused CBT (RFCBT)
- Keywords
- Rumination, Cognitive behavioural therapy (CBT), Depression, Anxiety
- Medical subject headings
- Depression, Dysthymic Disorder, Panic Disorder, Phobia, Social, Generalized Anxiety Disorder, Rumination Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rumination-Focused CBT (RFCBT)Behavioural
RFCBT consists of six online modules that include psycho-education, mood diaries, on-line experiential exercises using audio-recordings \& vignettes of participants experiences of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Rumination-Focused CBT (RFCBT) | Experimental | RFCBT seeks to change the process of thinking as opposed to the content of thoughts as in standard CBT. The underlying idea is that shifting individuals repetitive negative thinking into the concrete mode will reduce unconstructive ruminations and worries. Receives: Behavioral: Rumination-Focused CBT (RFCBT) |
| Wait List Control Group | 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.
Rumination Response Scale -10 items (RRS10)
The Rumination Response Scale -10 items (RRS10) was designed to measure participant's level of rumination. The scale has two subscale: Reflection (5 items) and Brooding (5 items). The score for each subscale ranges from 5 to 20, while the total score ranges from 10 to 40. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Measured: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ) was designed to measure participant's level of rumination. The scale is unidimensional and the total score ranges from 0 to 60. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Measured: Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Patient Health Questionnaire 9 (PHQ9)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Measured: Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Measured: Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Social Phobia Inventory (SPIN)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Measured: Absolute values (average score) of SPIN at 8 weeks (post-intervention)
Anxiety Sensitivity Index 16 (ASI16)
ASI16 was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score ranges from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.
Measured: Absolute values (average score) of ASI at 8 weeks (post-intervention)
Secondary outcomes (3)
Work and Social Adjustment Scale (WSAS)
Work and Social Adjustment Scale (WSAS) was designed to measure symptom interference. The scale is unidimensional and the total score ranges from 0 to 40. Low scores are associated with higher levels of functioning (less interference of clinical symptoms) while high scores are associated with lower levels of functioning (or high interference of clinical symptoms).
Measured: Absolute values (average score) of WSAS at 8 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 ranges from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Measured: Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
Penn State Worry Questionnaire (PSWQ)
The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Measured: Absolute values (average score) of PSWQ at 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start27 Mar 2018
- Primary completion30 Jul 2018 (estimated)
- Study completion27 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Bogdan Tudor Tulbure, PhD, Study director, West University of Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507114
- Sponsor's protocol ID
- WUTimisoara-iRFCBT
- Acronym
- iRFCBT
- Status last verified
- Feb 2018
- First submitted
- 19 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be process only at the group level. No individual data will be shared to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
- ClinicalTrials.gov ID
- NCT03507114
- Acronym / sponsor ID
- iRFCBT / WUTimisoara-iRFCBT
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder
- Keywords
- Rumination, Cognitive behavioural therapy (CBT), Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 27 Feb 2019 (estimated)
- First posted
- 24 Apr 2018 (actual)
- 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.
- To investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (WLCG).
- To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.
Detailed description
The effectiveness of a Rumination Focused Cognitive-Behavioral Treatment (RF-CBT) will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach was design to specifically target repetitive negative thinking (e.g., rumination and worries). Specifically, the treatment involves first a functional analysis design to help participants identify when rumination starts, distinguish between helpful versus unhelpful repetitive thinking, and learn more functional responses, and experiential and imagery exercises design to help them shift their thought processing towards concreteness, absorption and compassion. The main goal of the study is to test the effectiveness of this transdiagnostic approach in reducing symptom of depression and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rumination-Focused CBT (RFCBT) | Experimental | Behavioral: Rumination-Focused CBT (RFCBT)RFCBT seeks to change the process of thinking as opposed to the content of thoughts as in standard CBT. The underlying idea is that shifting individuals repetitive negative thinking into the concrete mode will reduce unconstructive ruminations and worries. |
| Wait List Control Group | 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 at least 18 years of age,
- display elevated levels of worry and/or rumination (e.g., at least one self-report score above the following cut-offs: Penn State Worry Questionnaire Total score > 50 and/or Rumination Response Scale - Brooding sub-scale ≥ 10)
- have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, and/or panic disorder, or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I)
Key exclusion criteria (7 listed)
- suicidal plans,
- changes in the dosage if psychotropic medication during the last month (if present),
- have bipolar disorder or psychosis (according to medication status)
- have an alcohol/substance abuse and/or dependence disorder
- currently take part in other psychological treatment,
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 |
|---|---|---|
| Rumination-Focused CBT (RFCBT)RFCBT consists of six online modules that include psycho-education, mood diaries, on-line experiential exercises using audio-recordings \& vignettes of participants experiences of the therapy. | Behavioural | Rumination-Focused CBT (RFCBT) |
Primary outcome
Rumination Response Scale -10 items (RRS10)
Time frame: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
The Rumination Response Scale -10 items (RRS10) was designed to measure participant's level of rumination. The scale has two subscale: Reflection (5 items) and Brooding (5 items). The score for each subscale ranges from 5 to 20, while the total score ranges from 10 to 40. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Perseverative Thinking Questionnaire (PTQ)
Time frame: Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Perseverative Thinking Questionnaire (PTQ) was designed to measure participant's level of rumination. The scale is unidimensional and the total score ranges from 0 to 60. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Patient Health Questionnaire 9 (PHQ9)
Time frame: Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Generalized Anxiety Disorder 7 (GAD7)
Time frame: Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Social Phobia Inventory (SPIN)
Time frame: Absolute values (average score) of SPIN at 8 weeks (post-intervention)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Anxiety Sensitivity Index 16 (ASI16)
Time frame: Absolute values (average score) of ASI at 8 weeks (post-intervention)
ASI16 was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score ranges from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.
3 secondary outcomes
Work and Social Adjustment Scale (WSAS)
Time frame: Absolute values (average score) of WSAS at 8 weeks (post-intervention)
Beck Depression Inventory-II (BDI-II)
Time frame: Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
Penn State Worry Questionnaire (PSWQ)
Time frame: Absolute values (average score) of PSWQ at 8 weeks (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Project official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be process only at the group level. No individual data will be shared to third parties.
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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.
Edward Watkins, PhD contact
Bogdan Tudor Tulbure, PhD study director
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 Rumination-Focused CBT (RFCBT) in people with Depression and Dysthymic Disorder, 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 7 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: status not confirmed, as of the sponsor's last update on 27 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bogdan Tudor Tulbure, PhD (0040745753061, btulbure@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rumination Response Scale -10 items (RRS10) (time frame: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)). The study lists 6 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 27 Apr 2018.