Does the audiovisual perception promotion (AVWF) as a supplementary treatment module of the inpatient multimodal psychosomatic complex treatment affect the symptoms ofHyperarousals and the subjective perception of stress, the quality of sleep and on the physiological level the heart rate variability?

Phase 3

• Conditions: F43.1; Post-traumatic stress disorder

• Registration Number: DRKS00012352
• Lead Sponsor: KGM Standort Gießen

Brief Summary

For the primary outcome hyperarousal (IES-R-H), mean values were reduced from M(pre) = 25.25 (SD = 6.30) to M(post) = 18.78 (SD = 9.38) in the intervention group, and from M(pre) = 25.64 (SD = 7.11) to M(post) = 23.00 (SD = 8.34) in the control group. The primary analysis applying the t-test yielded no significant group differences regarding hyperarousal post-intervention (IES-R-H: t(58)= 1.829, p = .073). The analyses of variance showed a significant within effect for the primary outcome hyperarousal (withinsubjects factor: F(1.58) = 21.22, p < .001) but no significant interaction effect (F(1.58) = 3.74, p = .085). Even though the interaction effect was statistically not significant, decreases in hyperarousal showed a tendency favoring the AVWF method. Significant within effects but no interaction effects can also be found regarding the secondary outcomes.

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-25
• Results First Posted: 2022-10-04
• Study Start: 2023-03-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

existence of a declaration of consent for the evaluation of the basic documentation in research projects; All patients who, upon admission to the University Clinic for Psychosomatics and Psychotherapy, Giessen, suffer from PTSD (ICD 10: F43.1), a panic disorder (ICD 10: F41.0) or a depressive disorder (ICD 10: F33.1, F32 .1) and show increased arousal in the hyperarousal subscale of the Impact of Event Scale (IES-R-Ü) (cut-off value = 15.8). Previous studies had shown that the mean (and the standard deviation) in the healthy non-traumatized control group at :M (SD) was 6.9 (8.9). (For comparison: in the samples victims of crime” and sexual violence” the following mean values ??were obtained in the subscale overarousal (IES-R-Ü): M(SD) 14.7 (10.7); sexual violence”: M (SD) 27.8 (6.0).

Exclusion Criteria

Hearing difficulties, cardiac arrhythmias, presence of a psychosis, organic brain disorders or acute suicidality, substance use. Missing declaration of consent for the evaluation of the basic documentation and the additional questionnaire (Regensburg Insomnia Scale, RIS), incomplete answers to the questionnaire.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subscale hyperarousal in the Impact of Event Scale revised (IES-R-H) at measurement times: t0 (screening, admission) and t1 (pre-intervention) and t2 (post-intervention)

Secondary Outcome Measures

Name	Time	Method
• Heart rate variability (HRV) / measurement times: t1 (pre-intervention) and t2 (post-intervention)<br>• Regensburg Insomnia Scale (RIS) / measurement times: t1 (pre-intervention) and t2 (post-intervention)<br>• Hospital Anxiety and Depression Scale (HADS)/ measurement times: t0 (admission) and t3 (discharge)<br>• Global Complaint Index (GSI) of the Symptom Checklist-90 (SCL-90) / measurement times: t0 (admission) and t3 (discharge)<br>• Experience of stress (PSQ-30) / measurement times: t0 (admission) and t3 (discharge)<br><br>