Depression Clinical Trial
— RECOVERYOfficial title:
RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
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.
Status | Recruiting |
Enrollment | 260 |
Est. completion date | March 27, 2020 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Romania | West University of Timisoara | Timi?oara | Timi? |
Lead Sponsor | Collaborator |
---|---|
West University of Timisoara |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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). | Absolute values (average score) of WSAS at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of BDI-II at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of PSWQ at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of ASI at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of SCCS at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of NGSE at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of USAQ at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of OASIS at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of ODSIS at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of RSES at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of SCS at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention) | |
Secondary | 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. | Absolute values (average score) of PCFTRT at 10 weeks (post-intervention) |
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