Psychological Interventions for Multiple Sclerosis: Effects on Anxiety, Depression, and Cognition.

A total of 153 individuals with RRMS were assessed for eligibility at the Multiple Sclerosis Unit of Hospital Universitario Nuestra Señora de Candelaria (HUNSC), Tenerife, Spain. Five individuals were excluded (three declined to participate and two did not meet the inclusion criteria), resulting in a final randomized sample of 148 participants. Participants were randomly allocated to one of three parallel study conditions: Group-Based Cognitive-Behavioral Therapy (CBT), Psychophysiological Regulation Therapy (PRT; active comparator), or Standard Care (SC; waiting-list control). Allocation was performed using a simple computer-generated randomization sequence created in IBM SPSS Statistics with a 1:1:1 allocation ratio. No blocking or stratification was used. The randomization sequence was generated by an independent member of the research team who was not involved in participant recruitment, outcome assessment, or treatment delivery. Following completion of baseline assessments and verification of eligibility, an anonymized participant list was provided to the independent methodologist, who generated the allocation sequence. Participants were subsequently assigned to the study conditions according to this predefined sequence. Participants allocated to the CBT and PRT conditions completed twelve weekly group sessions delivered over a 12-week period, followed by one individual follow-up session. Both active interventions shared a common therapeutic framework comprising psychoeducation about multiple sclerosis and stress management, mindfulness training, psychophysiological regulation strategies, and homework assignments. This common therapeutic framework was delivered in sessions lasting approximately 60 minutes. The PRT intervention comprised the common therapeutic framework throughout the 12-week program, with sessions lasting approximately 60 minutes. The CBT intervention incorporated the same common therapeutic framework but additionally included cognitive-behavioral components during sessions 4-10, comprising behavioral activation, thought stopping, self-instruction training, cognitive restructuring, problem-solving strategies, and social skills training. Sessions incorporating these additional CBT-specific components were extended to approximately 90 minutes, including a 10-minute break. Participants assigned to Standard Care continued receiving their usual neurological care and did not receive any additional psychological intervention during the trial. All participants continued receiving their usual neurological care, including disease-modifying treatment and routine clinical follow-up, throughout the study period. Assessments were conducted at baseline and immediately after completion of the 12-week intervention period. Psychological and emotional functioning was assessed using standardized self-report measures, and objective cognitive functioning was evaluated using standardized neuropsychological measures. Alternate forms of the Brief Repeatable Battery of Neuropsychological Tests (BRB-N) were used at baseline and post-treatment to minimize practice effects. Outcome assessors remained blinded to treatment allocation throughout the trial, although participants and therapists could not be blinded because of the nature of the psychological interventions. Clinical stability, relapse occurrence, changes in disease-modifying treatment, and the emergence of additional neurological or psychiatric conditions were monitored throughout the study. No intervention-related adverse events or unintended effects were reported.