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RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression (RECOVERY)

Primary Purpose

Depression, Dysthymic Disorder, Panic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Recovery (Transdiagnostic & self)
Transdiagnostic
Sponsored by
West University of Timisoara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Transdiagnostic, Cognitive behavioural therapy (CBT), Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • West University of TimisoaraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recovery (Transdiagnostic & self)

Transdiagnostic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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).
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.
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.
Anxiety Sensitivity Index 16 (ASI16)
The ASI was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score rages 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.
Self-Concept Clarity Scale (SCCS)
SCCS was designed to measure participant's level of their Self-Concept Clarity. The scale is unidimensional and the total score rages from 12 to 60. Low scores are associated with low levels of Self-Clarity, while high scores are associated with high levels of Self-Clarity.
New General Self-Efficacy Scale (NGSE)
NGSE was designed to measure participant's level of Self-Efficacy. The scale is unidimensional and the total score rages from 8 to 40. Low scores are associated with low levels of Self-Efficacy, while high scores are associated with high levels of Self-Efficacy.
Unconditional Self-Acceptance Questionnaire (USAQ)
USAQ was designed to measure participant's level of unconditional Self-Acceptance. The scale is unidimensional and the total score rages from 20 to 140. Low scores are associated with low levels of unconditional Self-Acceptance, while high scores are associated with high levels of unconditional Self-Acceptance.
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS was designed to measure participant's level of overall anxiety level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS was designed to measure participant's level of overall depression level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Rosenberg Self-Esteem Scale (RSES)
Rosenberg Self-Esteem Scale was designed to measure participant's level of Self-Esteem. The scale is unidimensional and the total score rages from 10 to 40. Low scores are associated with low levels of Self-Esteem, while high scores are associated with high levels of Self-Esteem.
Self-Compassion Scale (SCS)
SCS was designed to measure participant's level of their Self-Compassion. The scale is multidimensional and the total score rages from 26 to 130. Low scores are associated with low levels of Self-Compassion, while high scores are associated with high levels of Self-Compassion.
Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)
MMPI2TRT was designed to measure participants negative attitudes toward doctors/mental health professionals and unwilling to discuss personal problems. The scale is unidimensional and the total score rages from 0 to 26. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.
Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)
PCFTRT is a new subscale designed to assess participants negative attitudes toward mental health professionals and unwilling to discuss personal problems. The subscale is unidimensional and the total score rages from 0 to 24. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.

Full Information

First Posted
April 14, 2019
Last Updated
April 14, 2019
Sponsor
West University of Timisoara
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1. Study Identification

Unique Protocol Identification Number
NCT03917550
Brief Title
RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression
Acronym
RECOVERY
Official Title
RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
March 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder, Specific Phobia
Keywords
Transdiagnostic, Cognitive behavioural therapy (CBT), Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery (Transdiagnostic & self)
Arm Type
Experimental
Arm Description
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.
Arm Title
Transdiagnostic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery (Transdiagnostic & self)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire 9 (PHQ9)
Description
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.
Time Frame
Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)
Title
Generalized Anxiety Disorder 7 (GAD7)
Description
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.
Time Frame
Absolute values (average score) of GAD7 at 10 weeks (post-intervention)
Title
Social Phobia Inventory (SPIN)
Description
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.
Time Frame
Absolute values (average score) of SPIN at 10 weeks (post-intervention)
Title
Panic Disorder Severity Scale-Self Report (PDSS-SR)
Description
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.
Time Frame
Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS)
Description
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).
Time Frame
Absolute values (average score) of WSAS at 10 weeks (post-intervention)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Absolute values (average score) of BDI-II at 10 weeks (post-intervention)
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Absolute values (average score) of PSWQ at 10 weeks (post-intervention)
Title
Anxiety Sensitivity Index 16 (ASI16)
Description
The ASI was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score rages 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.
Time Frame
Absolute values (average score) of ASI at 10 weeks (post-intervention)
Title
Self-Concept Clarity Scale (SCCS)
Description
SCCS was designed to measure participant's level of their Self-Concept Clarity. The scale is unidimensional and the total score rages from 12 to 60. Low scores are associated with low levels of Self-Clarity, while high scores are associated with high levels of Self-Clarity.
Time Frame
Absolute values (average score) of SCCS at 10 weeks (post-intervention)
Title
New General Self-Efficacy Scale (NGSE)
Description
NGSE was designed to measure participant's level of Self-Efficacy. The scale is unidimensional and the total score rages from 8 to 40. Low scores are associated with low levels of Self-Efficacy, while high scores are associated with high levels of Self-Efficacy.
Time Frame
Absolute values (average score) of NGSE at 10 weeks (post-intervention)
Title
Unconditional Self-Acceptance Questionnaire (USAQ)
Description
USAQ was designed to measure participant's level of unconditional Self-Acceptance. The scale is unidimensional and the total score rages from 20 to 140. Low scores are associated with low levels of unconditional Self-Acceptance, while high scores are associated with high levels of unconditional Self-Acceptance.
Time Frame
Absolute values (average score) of USAQ at 10 weeks (post-intervention)
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
The OASIS was designed to measure participant's level of overall anxiety level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Time Frame
Absolute values (average score) of OASIS at 10 weeks (post-intervention)
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
The ODSIS was designed to measure participant's level of overall depression level. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Time Frame
Absolute values (average score) of ODSIS at 10 weeks (post-intervention)
Title
Rosenberg Self-Esteem Scale (RSES)
Description
Rosenberg Self-Esteem Scale was designed to measure participant's level of Self-Esteem. The scale is unidimensional and the total score rages from 10 to 40. Low scores are associated with low levels of Self-Esteem, while high scores are associated with high levels of Self-Esteem.
Time Frame
Absolute values (average score) of RSES at 10 weeks (post-intervention)
Title
Self-Compassion Scale (SCS)
Description
SCS was designed to measure participant's level of their Self-Compassion. The scale is multidimensional and the total score rages from 26 to 130. Low scores are associated with low levels of Self-Compassion, while high scores are associated with high levels of Self-Compassion.
Time Frame
Absolute values (average score) of SCS at 10 weeks (post-intervention)
Title
Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)
Description
MMPI2TRT was designed to measure participants negative attitudes toward doctors/mental health professionals and unwilling to discuss personal problems. The scale is unidimensional and the total score rages from 0 to 26. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.
Time Frame
Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention)
Title
Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)
Description
PCFTRT is a new subscale designed to assess participants negative attitudes toward mental health professionals and unwilling to discuss personal problems. The subscale is unidimensional and the total score rages from 0 to 24. Low scores are associated positive attitudes towards doctors and willingness to discuss problems while high scores are associated with negative attitudes toward doctors and unwilling to discuss personal problems.
Time Frame
Absolute values (average score) of PCFTRT at 10 weeks (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea Isbasoiu, PhD student
Organizational Affiliation
West University of Timisoara
Official's Role
Study Director
Facility Information:
Facility Name
West University of Timisoara
City
Timișoara
State/Province
Timiș
ZIP/Postal Code
300223
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be process only at the group level. No individual data will be shared to third parties.
Citations:
PubMed Identifier
34925157
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.
Results Reference
derived
Links:
URL
https://www.e-cbt.ro/program/recovery
Description
Project official website

Learn more about this trial

RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression

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