Clinical trial NCT03917550: RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression
Official title: RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Dysthymic Disorder
Panic Disorder
Social Phobia
Generalized Anxiety Disorder
Specific Phobia
Keywords: Transdiagnostic
Cognitive behavioural therapy (CBT)
Depression
Anxiety
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 260
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: To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.

Detailed description: The effectiveness of a Transdiagnostic Cognitive-Behavioral Treatment will be compared with an improved version of it, in which new intervention techniques were added, pointing out the importance of improving some self-concept dimensions in reducing symptoms of anxiety and depression. In order to prove this, the study design will include two active intervention groups; a standard transdiagnostic intervention protocol will be delivered to one group and an improved version of the same transdiagnostic protocol will be delivered to the other group. The new added techniques targets some self-concepts, namely self-compassion, unconditional self-acceptance and self-esteem. The main goal of the study is to concurrently test effectiveness of these two transdiagnostic approaches in reducing symptoms of anxiety and depression and improving the above-mentioned self-concepts. This non-inferiority trial has the power to detect an effect size larger than Cohen's d = .40 (including 20% attrition at post-test and 6 month follow-up)

Eligibility criteria: Inclusion Criteria:

1. be fluent in Romanian,
2. be at least 18 years of age,
3. have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, panic anxiety disorder and/or Agoraphobia, specific phobia or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID-I 5)

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.)

Primary outcomes:
measure: Patient Health Questionnaire 9 (PHQ9)
timeFrame: Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)
measure: Generalized Anxiety Disorder 7 (GAD7)
timeFrame: Absolute values (average score) of GAD7 at 10 weeks (post-intervention)
measure: Social Phobia Inventory (SPIN)
timeFrame: Absolute values (average score) of SPIN at 10 weeks (post-intervention)
measure: Panic Disorder Severity Scale-Self Report (PDSS-SR)
timeFrame: Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)
Secondary outcomes:
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Absolute values (average score) of WSAS at 10 weeks (post-intervention)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Absolute values (average score) of BDI-II at 10 weeks (post-intervention)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Absolute values (average score) of PSWQ at 10 weeks (post-intervention)
measure: Anxiety Sensitivity Index 16 (ASI16)
timeFrame: Absolute values (average score) of ASI at 10 weeks (post-intervention)
measure: Self-Concept Clarity Scale (SCCS)
timeFrame: Absolute values (average score) of SCCS at 10 weeks (post-intervention)
measure: New General Self-Efficacy Scale (NGSE)
timeFrame: Absolute values (average score) of NGSE at 10 weeks (post-intervention)
measure: Unconditional Self-Acceptance Questionnaire (USAQ)
timeFrame: Absolute values (average score) of USAQ at 10 weeks (post-intervention)
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Absolute values (average score) of OASIS at 10 weeks (post-intervention)
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Absolute values (average score) of ODSIS at 10 weeks (post-intervention)
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Absolute values (average score) of RSES at 10 weeks (post-intervention)
measure: Self-Compassion Scale (SCS)
timeFrame: Absolute values (average score) of SCS at 10 weeks (post-intervention)
measure: Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)
timeFrame: Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention)
measure: Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)
timeFrame: Absolute values (average score) of PCFTRT at 10 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: Andreea Isbasoiu, PhD student
role: STUDY_DIRECTOR
References:
citation: Isbasoiu AB, Tulbure BT, Rusu A, Sava FA. Can We Boost Treatment Adherence to an Online Transdiagnostic Intervention by Adding Self-Enhancement Strategies? Results From a Randomized Controlled Non-inferiority Trial. Front Psychol. 2021 Dec 2;12:752249. doi: 10.3389/fpsyg.2021.752249. eCollection 2021.