RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression

West University of Timisoara

Status: Unknown

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

Treatments: Behavioral: Transdiagnostic; Behavioral: Recovery (Transdiagnostic & self)

Study type: Interventional

Funder types: Other

Identifiers

NCT03917550

WUT - RECOVERY

Details and patient eligibility

About

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.

Full 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)

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Recovery (Transdiagnostic & self)

Experimental group

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.

Treatment:

Behavioral: Recovery (Transdiagnostic & self)

Transdiagnostic

Active Comparator group

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.

Treatment:

Behavioral: Transdiagnostic