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A pilot, single-arm feasibility study of a multidimensional behavioral intervention for cognitive fatigability in
Tamanna Islam1,2, Jason A Berard1,2,3, Abby Ryan4
1Department of Psychology, University of Ottawa, Ottawa, ON, Canada.
Background:
Cognitive fatigability (CF), the decline in performance following sustained cognitive effort, remains less understood in people with multiple sclerosis (PwMS) than subjective fatigue, and no behavioral interventions have yet specifically targeted CF in PwMS.
Purpose:
This study assessed the feasibility of an 8-week, group-based, video conference-delivered behavioral intervention for CF in PwMS to determine if proceeding to a full-scale randomized controlled trial (RCT) is advised.
Methods:
The program was adapted from a validated teleconference-based program for fatigue in MS, incorporating additional components targeting factors known to contribute to CF, and informed by investigators' clinical expertise and perspectives of PwMS from a needs assessment survey. Following the sessions, focus group discussions took place to gather participant's feedback. Feasibility was assessed by tracking eligibility, recruitment, adherence, completion, acceptability, and treatment fidelity, using a traffic-light framework (GREEN = proceed to RCT; AMBER = amend before proceeding to RCT; RED = do not proceed to RCT) to determine whether modifications are needed before a full trial, with thresholds based on prior feasibility studies.
Results:
Of 39 PwMS screened from an MS clinic sample, 21 (54%) were eligible and 18 were enrolled (86%), reflecting a high recruitment uptake. Recruitment was completed over 9 months. Satisfaction with the overall program was high, with 92% respondents rating their satisfaction >5 on a 10-point scale (1 = completely dissatisfied; 10 = completely satisfied). Perceived helpfulness of sessions was also high (92% scoring ≥ 24/40). Per session attendance ranged from 59% to 94% (Mean = 81.62%), with an 89% (n = 16) completion rate, and a 94% (n = 15) focus group attendance rate. Treatment fidelity (i.e., coverage of manualized content) was high, with the facilitator adhering to the session length in 79% of sessions.
Conclusion:
Most feasibility indicators met "GREEN" criteria, supporting progression to a full trial. Recruitment period duration was the only indicator that fell within the AMBER zone, indicating a need for procedural adjustments before a full trial. No indicator fell in the RED zone.
