Rumination Focus Cognitive Behavior Therapy

Depression Clinical Trial

— iRFCBT  

Official title:

An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507114
• Other study ID #: WUTimisoara-iRFCBT
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2018
• Last updated: April 25, 2018
• Start date: March 27, 2018
• Est. completion date: February 27, 2019

Study information

• Verified date: February 2018
• Source: West University of Timisoara
• Contact: Bogdan Tudor Tulbure, PhD
• Phone: 0040745753061
• Email: btulbure[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 27, 2019
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be fluent in Romanian,

2. be at least 18 years of age,

3. 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)

4. 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)

Exclusion Criteria:

1. suicidal plans,

2. changes in the dosage if psychotropic medication during the last month (if present),

3. have bipolar disorder or psychosis (according to medication status)

4. have an alcohol/substance abuse and/or dependence disorder

5. currently take part in other psychological treatment,

6. obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.);

7. have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• Dysthymic Disorder
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Phobia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Romania	West University of Timisoara	Timi?oara	Timi?

Sponsors (2)

Lead Sponsor	Collaborator
West University of Timisoara	University of Exeter

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
Primary	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.	Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Primary	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.	Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
Primary	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.	Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Primary	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.	Absolute values (average score) of SPIN at 8 weeks (post-intervention)
Primary	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.	Absolute values (average score) of ASI at 8 weeks (post-intervention)
Secondary	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).	Absolute values (average score) of WSAS at 8 weeks (post-intervention)
Secondary	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.	Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
Secondary	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.	Absolute values (average score) of PSWQ at 8 weeks (post-intervention)

External Links

•   Project official website