Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial
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RESEARCH ARTICLE
Transdiagnostic treatment of emotional disorders for women with multiple sclerosis: a randomized controlled trial Nabi Nazari1* , Akram Aligholipour2 and Masoud Sadeghi1
Abstract Background: Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated. Objective: This study aimed to examine the efficacy of a group format of the Unified Protocol (UP) for the Transdiagnostic treatment of depression and anxiety disorders in females with MS. Methods: In the present study, Sixty-four adult females diagnosed with MS were randomized to either the UP (n = 32) or treatment-as-usual conditions. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity. Results: Repeated measure analysis of variance (ANOVA) revealed that the UP significantly improved depression scores [Cohen’s d = − 2.11, 95% CI (− 2.72, − 1.50)], anxiety scores [Cohen’s d = − 3.34, 95% CI (− 4.01, − 2.58)], positive and negative affect scale (PANAS)-positive affect scores [Cohen’s d = 1.46, 95% CI (1.46, 2.01)], PANAS-negative affect scores [Coen’s d = − 2.21, 95% CI (− 2.84, − 1.60)], difficulties emotion regulation scale scores [Cohen’s d = 1.40, 95% CI (− 0.87, − 0.03)], and Worry scale scores [Cohen’s d = − 0.45, 95% CI (− 0.95, − 0.04)] at the end of treatment relative to compared to the control condition. Also, treatment gains were maintained at the three-month follow-up (p 97, the HADS-A score ≥ 11, and the HADS-D score ≥ 11, were selected for randomization. The participants were informed that they could withdraw the consent or stop participating, any point of the study. Also, they were free to skip specific questions and continue participating. The outcomes were assessed at three time-points: Time 1: pretreatment to pre-allocation include baseline, Time 2: immediate after intervention: post-treatment assessment, and Time 3: immediate at the end of the three-month follow-up. Sample size
The Sample size for a repeated measure analysis of variance (ANOVA) with two groups: UP vs. TAU), and three measurement times (baseline, post-treatment, and threemonth follow-up) conducted using GPower version 3
Table 2 Study schedule of enrolment, intervention, and assessment Assessment Duration Informed consent
Enrollment schedule
Intervention schedule
Follow-up schedule
2 months
14 weeks
3 months
×
×
×
SCID-I–IV interview
×
Demographic question
×
Intervention Unified protocol
←→
Treatment as usual
←→
Primary outcome HADS
×
×
×
DERS
×
×
×
Secondary outcome PANAS
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