RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression

NCT03917550 | Unknown

• 1 other identifier: WUT - RECOVERY
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Dysthymic Disorder; Panic Disorder; Social Phobia; Generalized Anxiety Disorder; Specific Phobia

Keywords

Transdiagnostic; Cognitive behavioural therapy (CBT); Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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 10 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.

  Absolute values (average score) of GAD7 at 10 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.

  Absolute values (average score) of SPIN at 10 weeks (post-intervention)

• Panic Disorder Severity Scale-Self Report (PDSS-SR)

  The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.

  Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)

Secondary Outcomes (13)

• Work and Social Adjustment Scale (WSAS)

  Absolute values (average score) of WSAS at 10 weeks (post-intervention)

• Beck Depression Inventory-II (BDI-II)

  Absolute values (average score) of BDI-II at 10 weeks (post-intervention)

• Penn State Worry Questionnaire (PSWQ)

  Absolute values (average score) of PSWQ at 10 weeks (post-intervention)

• Anxiety Sensitivity Index 16 (ASI16)

  Absolute values (average score) of ASI at 10 weeks (post-intervention)

• Self-Concept Clarity Scale (SCCS)

  Absolute values (average score) of SCCS at 10 weeks (post-intervention)

Study Arms (2)

Recovery (Transdiagnostic & self)

EXPERIMENTAL

A longitudinal study conducted before has shown that self-compassion, unconditional self-acceptance, self-esteem and self concept clarity could be considered risk factors for the severity of the clinical symptoms in anxiety and depression. This is the main reason why this arm consists of the Transdiagnostic intervention program for emotional disorders plus a number of intervention techniques targeting the self-concepts mentioned before. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. Moreover, additional intervention techniques targeting self-concepts will be used to improve participants' self.

Behavioral: Recovery (Transdiagnostic & self)

Transdiagnostic

ACTIVE COMPARATOR

This arm represents the Transdiagnostic intervention program for emotional disorders. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms.

Behavioral: Transdiagnostic

Interventions

Recovery (Transdiagnostic & self) BEHAVIORAL

This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors. In addition, specific intervention designed to improve self-compassion, unconditional self-acceptance, self-esteem and self concept clarity were added.

Recovery (Transdiagnostic & self)

Transdiagnostic BEHAVIORAL

This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors.

Transdiagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be fluent in Romanian,
• be at least 18 years of age,
• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• West University of Timisoara: lead

Study Sites (1)

West University of Timisoara

Timișoara, Timiș County, 300223, Romania

RECRUITING

Related Publications (1)

• 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.

  PMID: 34925157 DERIVED

Related Links

• Project official website

MeSH Terms

Conditions

Depression; Dysthymic Disorder; Panic Disorder; Phobia, Social; Generalized Anxiety Disorder; Phobia, Specific; Anxiety Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Andreea Isbasoiu, PhD student

  West University of Timisoara

  STUDY DIRECTOR

Central Study Contacts

Bogdan Tudor Tulbure, PhD

CONTACT

0040745753061; btulbure@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 17, 2019
• Study Start: March 18, 2019
• Primary Completion: August 30, 2019
• Study Completion: March 27, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)