Comparison Of The Effectiveness Of Acceptance And Commitment Based Therapy With Schema Therapy On Depression, Health Anxiety, Adaptive Behavior And Psychological Hardiness In Patients With MS In Isfahan During The Covid-19 Epidemic

A comparative study of the effectiveness of acceptance and commitment therapy with schema therapy on depression, health anxiety, adaptive behavior, and psychological hardiness in patients with multiple sclerosis in Isfahan during the Covid-19 epidemic.

This is a three-arm, parallel-group, semi-experimental trial. Participants will be randomly assigned to two intervention groups (ACT or Schema Therapy) or a waitlist control group.

The study will be conducted in Isfahan, Iran. Participants will be randomly assigned to ACT, Schema Therapy, or a waitlist control group. Interventions include 8 weekly 2-hour sessions, with outcomes assessed at baseline, post-intervention, and follow-up by blinded assessors using concealed computerised randomisation.

Participants in this study will include patients diagnosed with Multiple Sclerosis (MS) confirmed by a neurologist, aged between 18 and 60 years, who are able to read and write in Persian, have a stable medical condition without acute relapse during the last month, and provide informed consent to attend group therapy sessions. Exclusion criteria will be the presence of severe psychiatric disorders such as psychosis or bipolar disorder, current participation in other psychological interventions, substance abuse or dependence, cognitive impairments interfering with participation, and absence from more than two intervention sessions.

This study includes three groups: two intervention groups receiving 8 weekly 2-hour sessions of ACT or Schema Therapy, and a waitlist control group attending a 2-hour MS educational workshop.

Depression scores; Health anxiety scores; Adjustment behavior scores; Psychological resilience scores

Participants were randomly assigned to one of three groups—Acceptance and Commitment Therapy (ACT), Schema Therapy, or Waitlist Control—in a 1:1:1 ratio. To ensure balance and control for potential confounders, randomization was stratified by gender (male/female) and disease severity (EDSS < 3.5 vs. ≥ 3.5). Within each stratum, variable block sizes (3, 6, and 9) were used to generate the allocation sequence. The random sequence was generated by an independent researcher using computer-based random number generation with a fixed seed to allow reproducibility. Allocation concealment was achieved through the use of sequentially numbered, opaque, sealed envelopes (SNOSE), prepared for each stratum. After informed consent was obtained and baseline assessment (T1) was completed, the study coordinator opened the next envelope corresponding to the participant’s stratum to determine group assignment. Outcome assessors at post-test (T2) and follow-up (T3) were blinded to participants’ group allocation to reduce bias. Data analysis followed the intention-to-treat principle, and participant flow through each stage of the study was documented using a CONSORT flow diagram.

Due to the nature of psychological interventions, it was not possible to blind the participants to the type of treatment they received. However, to minimize bias, the study was conducted in a single-blind manner. Specifically, the outcome assessor who was responsible for data collection and analysis was blinded to the group allocation (Acceptance and Commitment Therapy vs. Schema Therapy). This procedure was implemented to enhance the accuracy of assessments and reduce the influence of researcher or participant expectations on the study outcomes.

"Study results along with anonymized participant data"

"From the time of publication until one year thereafter"

"All researchers and clinical specialists"

"For clinical and research purposes"

Formal request to the corresponding author

Initially discussed within the research team, and ultimately, the data will be shared upon approval