Integrated Imaginative Distention Therapy to Cope with Fatigue. DIMMI SI Study: The First Randomized Controlled Trial in Multiple Sclerosis

Abstract

IntroductionFatigue is a frequent, disabling, and difficult to treat symptom in neurological disease and in other stress-related conditions; Integrated Imaginative Distention (IID) is a therapy combining muscular and imaginative relaxation, feasible also in disabled subjects; the DIMMI SI trial was planned to evaluate IID efficacy on fatigue.MethodsThe design was a parallel, randomised 1:1 (intervention:waiting list), controlled, open-label trial. Participants were persons with multiple sclerosis (pwMS), persons with insomnia (pwINS), and health professionals (HP) as conditions related to fatigue and stress. The primary outcome was the post-intervention change of fatigue; secondary outcomes were changes in insomnia, stress, and quality of life (QoL). Eight IID weekly training group sessions were delivered by a skilled psychotherapist. The study lasted 12 months.ResultsOne hundred and forty-four subjects were enrolled, 48 for each condition. The mean change in Modified Fatigue Impact Scale (MFIS) score among exposed was 7.7 [95% CI 1.1, 14.4] (P = 0.023) in pwMS; 7.1 [1.9, 12.3] (P = 0.007) among pwINS, and 11.3 [4.3, 18.2] among HP (P = 0.002). At the last follow-up, the benefit was confirmed on physical fatigue for pwMS, on total fatigue for pwINS and HP.ConclusionsDIMMI SI is the first randomized controlled trial evaluating the efficacy of IID on fatigue. IID resulted a complementary intervention to reduce fatigue in stress-related conditions, in both health and disease status. NCT02290990ClinicalTrials.gov.Electronic supplementary materialThe online version of this article (doi:10.1007/s40120-017-0081-9) contains supplementary material, which is available to authorized users.

Which behavioural and exercise interventions targeting fatigue show the most promise in multiple sclerosis? A systematic review with narrative synthesis and meta-analysis

“…Limited information was provided about the intervention evaluated in Nazari, Shahreza, Shaygannejad, and Valiani (2015), it consisted of twice weekly relaxation sessions of 40 minutes over 4 weeks. In Sgoifo et al (2017), participants received Jacobsen relaxation exercises biweekly over the course of 8 weeks, with sessions lasting between 40 and 60 minutes delivered by one psychotherapist. At the end of treatment, 4% attrition was observed in the treatment group.…”

Behavioral interventions to improve sleep outcomes in people with multiple sclerosis: A systematic review

“…Sajadi et al’s 69 RCT reported a significant difference in sleep quality between the group that participated in foot reflexology and the placebo group following the intervention; however, the intervention group’s average PSQI score was significantly worse than the control group’s PSQI score at baseline. Sgoifo et al’s 34 RCT reported no significant difference in ISI change scores between the integrative imaginative distention intervention group and the waitlist control group. In Jensen et al’s pilot RCT, 64 participants received an intervention with neurofeedback and hypnosis (NF-HYP), mindfulness and hypnosis (MM-HYP), or hypnosis alone (control).…”

“…39,51,57 Sleep was stated as the primary outcome in nine 26,27,32,36,41,43,45,46,50 of the 37 studies. The Pittsburg Sleep Quality Index (PSQI) was the most commonly used sleep outcome utilized in 19 26,29-31,35-39,41,42,44,48,50,53-55,57,60 of the studies followed by the Insomnia Severity Index (ISI) (n=10 32-34,37,39,42,44,45,56,62 ), actigraphy (n=5 37,38,43,46,60 ), and sleep log/diary data (n=5 38,43,46,56,57 ); six of the studies incorporated an objective measurement (actigraphy (n=5 38,43,46,56,57 ); EEG (n=1 45 )). Interventions included physical activity (n=13 31-33,37-39,41,45,46,50,51,53,55 ), CBT-I (n=6 42-44,56,57,62 ), CBT/psychotherapy (n=4 26,27,30, ), mindfulness/relaxation (n=6 28,48,49,58-60 ), education and self-management support (n=3 29,36,54,61 ), and complementary and alternative interventions including acupuncture 47 , neurofeedback and hypnosis 64 , trauma releasing exercises 52 , foot reflexology 35 , integrated imaginative distention 34 (all ...…”

“…34 None included sleep as the primary outcome. Three were RCTs, 34,35 one of which self-identified as a pilot RCT, 64 and two utilized a single group pre-post study design. 47,52…”

“…34 None included sleep as the primary outcome. Three were RCTs, 34,35 one of which self-identified as a pilot RCT, 64 and two utilized a single group pre-post study design. 47,52 Sajadi et al's 69 RCT reported a significant difference in sleep quality between the group that participated in foot reflexology and the placebo group following the intervention; however, the intervention group's average PSQI score was significantly worse than the control group's PSQI score at baseline.…”