Effectiveness of Online vs. In-Person Unified Protocol Group Therapy on Transdiagnostic Components in Patients with Multiple Sclerosis Comorbid with Depression and Anxiety

Evaluating the Effectiveness of Online and In-Person Transdiagnostic Group Therapy (Unified Protocol) on Transdiagnostic Components in Patients with Multiple Sclerosis Comorbid with Depression and Anxiety

A phase 2, randomized, two side blinded, parallel-group clinical trial on 40 patients.

The intervention will be conducted at the Omid Zanjan Charity in a group format for MS patients to improve their quality of life, consisting of 12 sessions. Each session will last 45 minutes. According to the Unified Protocol for Transdiagnostic Treatment by Barlow, the modules and the specified number of sessions for each module will be implemented. To minimize bias in outcome assessment and data analysis, a "blinding of outcome assessor and data analyst" method was used.

MS diagnosis confirmed by a neurologist؛Minimum middle school education؛ No substance use disorders؛ No other concurrent psychotherapy؛ Age 20-40 years؛ No severe psychiatric disorders؛ Ambulatory (EDSS <6.5)؛ BDI-II score of 0-16 (mild-moderate depression)؛ BAI score of 0-25 (mild-moderate anxiety) Development of new severe psychiatric conditions؛MS relapse or increase in EDSS to ≥6.5؛ Absence from more than 2 sessions؛ Acute psychological crisis؛ Increase in BDI-II score to >16 or BAI score to >25

In this study, participants in the intervention group will receive 12 therapy sessions, each lasting 45 minutes. The first intervention group will attend these sessions in person, while the second group will participate online. The primary focus of the sessions will be on cognitive restructuring, body awareness, present-moment awareness (mindfulness), teaching the concepts of opposite action, and the three components of emotion, which include thoughts, bodily sensations, and behaviors.

Depression and anxiety severity؛ MS-related quality of life

Based on the selection criteria, a sample size of 40 individuals has been determined, all of whom are members of the MS Association in Zanjan. The sample will be selected using a convenience sampling method according to the inclusion criteria and will be randomly assigned to two groups: virtual intervention and online intervention. Each of these groups will be further divided into two subgroups of ten individuals. The two intervention groups will receive in-person and online therapy, respectively. Each group will consist of 20 individuals.

In this trial, due to the nature of the interventions (online therapy versus in-person therapy), blinding of the participants and therapists was not feasible. The participants and therapists are naturally aware of the type of intervention they are receiving or delivering. However, to minimize bias in the outcome assessment and data analysis, a method of "outcome assessor and data analyst blinding" was employed. Outcome assessors, who were responsible for collecting primary outcome data (such as scores on psychological questionnaires, functional assessments, etc.), were kept unaware of the participants' group allocation. The individual or team who performed the final statistical analyses were unaware of the identity of the groups (i.e., which statistical code corresponded to the "online" group and which to the "in-person" group). The data provided to the analysts were labeled with neutral codes (e.g., "Group A" and "Group B"). The linkage between these codes and the actual group identities was only revealed after the completion of the primary statistical analyses, for the purpose of drafting the results.