Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: The study comparing a psychological group intervention, based on transdiagnostic therapy principles developed by Barlow et al. (the Unified Protocol), with a control group. Group therapy consists of 14 weekly 2‐h sessions with a 15‐min break after 60 min. Participants were randomly assigned to the treatment or control groups using a computerised method (www.randomizer.org). The intervention comprised the following modules: 1. Module 1 (session 1): Unified model of psychopathology, motivation enhancement strategies, treatment goal setting, decisional balance exercise, changing versus staying 2. Module 2 (session 2): Psychoeducation on the adaptive function of emotions, three‐component model of emotional experiences, describing the sequence of events around emotions, anchoring in the present 3. Module 3 (sessions 3 and 4): Reviewing primary emotions, natural course of emotions and role of avoidance, present‐focused, non‐judgmental emotion awareness, recognising the interaction between thoughts, feelings and behaviours during an emotional experience 4. Module 4 (sessions 5 and 6): Flexible thinking, automatic appraisals , thinking traps, distress tolerance skills, familiarizing with various emotional avoidance strategies and their impact on emotional experience, knowledge of the contradictory effects of avoiding emotions 5. Module 5 (session 7): Examining emotion‐driven behaviours (EDBs), knowledge and identification of their effects on emotional experiences, identifying maladaptive EDBs, and creating alternatives for acting through behaviours 6. Module 6 (session 8): Increasing patients’ awareness and tolerance of somatic sensations, knowledge and tolerance of physical senses, increasing awareness of the role of emotional feelings in emotional experiences, practicing exercises or visceral confrontation in order to be aware CONDITION: Anxiety and depression in patients with multiple sclerosis ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; At baseline, post‐treatment (14‐weeks), and three months:; 1. Psychological or psychiatric diagnosis assessed using SCID‐DSM‐IV: The Structured Clinical Interview for DSM‐IV (SCID); 2. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ); 3. Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale; 4. Depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) depression subscale; SECONDARY OUTCOME: ; Current secondary outcome measures as of 08/11/2019:; 1. Mindfulness (mindful observation, non‐aversion, non‐judgment, and letting go) assessed using the Southampton Mindfulness Questionnaire (SMQ); 2. Emotionality assessed using the Emotional style Questionnaire (2019) ESQ; 3. Depression symptoms assessed using the Beck Depression Inventory; 4. Emotional dysregulation assessed using the Difficulties in Emotion Regulation Scale (DERS); 5. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ); ; ; Previous secondary outcome measures:; At baseline, post‐treatment (14‐weeks), and three months:; 1. Psychological or psychiatric diagnosis assessed using SCID‐DSM‐IV: The Structured Clinical Interview for DSM‐IV (SCID); 2. Anxiety‐related symptom severity and impairment assessed using the Overall Anxiety Severity and Impairment Scale (OASIS); 3. Tendency, intensity and excessiveness of worry assessed using the Penn State Worry Questionnaire (PSWQ); 5. Emotional regulation assessed using the Emotion Regulation Questionnaire (ERQ‐R); 6. Positive and negative affect assessed using the Positive and Negative Affect Schedule (PANAS); 7. Mindfulness (mindful observation, non‐aversion, non‐judgment, and letting go) assessed using the Southampton Mindfulness Questionnaire (SMQ); 8. Emotional dysregulation assessed using the Difficulties in Emotion Regulation Scale (DERS); 9. Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale; 10. Depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS) depression; INCLUSION CRITERIA: Current inclusion criteria as of 08/11/2019: 1. Valid MS diagnosis 2. No suicidal Ideation or threatening behaviors, no history span attempted suicide 3. Valid diagnosis of depression or anxiety disorder 4. Internet availability Previous INCLUSION CRITERIA: 1. Diagnosis of MS for 3 years or more 2. Fluent in Persian 3. At least 18 years of age 4. Received at least one current diagnostic of a valid depression disorder and an anxiety disorder on Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth Edition Axis I Disorders 5. Received at least one self‐report score, without the cut‐off range, specified for each of screening domains: 5.1 Anxiety screening measures included the Penn State Worry Q
Epistemonikos ID: 52ffb6dbff18d28754a36c5cbd0ea273be51b275
First added on: Aug 24, 2024