Clinical trial NCT03507114: Rumination Focus Cognitive Behavior Therapy
Official title: An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Dysthymic Disorder
Panic Disorder
Social Phobia
Generalized Anxiety Disorder
Keywords: Rumination
Cognitive behavioural therapy (CBT)
Depression
Anxiety
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2018-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rumination Response Scale -10 items (RRS10)
timeFrame: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Absolute values (average score) of PTQ at 8 weeks (post-intervention)
measure: Patient Health Questionnaire 9 (PHQ9)
timeFrame: Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
measure: Generalized Anxiety Disorder 7 (GAD7)
timeFrame: Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
measure: Social Phobia Inventory (SPIN)
timeFrame: Absolute values (average score) of SPIN at 8 weeks (post-intervention)
measure: Anxiety Sensitivity Index 16 (ASI16)
timeFrame: Absolute values (average score) of ASI at 8 weeks (post-intervention)
Secondary outcomes:
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Absolute values (average score) of WSAS at 8 weeks (post-intervention)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Absolute values (average score) of PSWQ at 8 weeks (post-intervention)
Other outcomes:
Locations:
city: Timișoara
country: Romania
facility: West University of Timisoara
state: Timiș
Study officials:
affiliation: West University of Timisoara
name: Bogdan Tudor Tulbure, PhD
role: STUDY_DIRECTOR
References: