Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cognitive Change
  • Psychological Adaptation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Research group, 35-40 participants (8 sessions in 4 months) Control group (health and lifestyle counselling), 35-40 participants (6 sessions in 3 months)Masking: Single (Outcomes Assessor)Masking Description: Laboratory measurements autonomic nervous system ganglio antibodies.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Testing and inventories before treatment/ at the end of the treatment and 3 months follow-up: Inventories: PHQ-4, HADS, BDQ,CFQ, PRMQ, FSS, WHODAS 2.0, SOC- 29, YSQ L3a, Compass31, Pichot, Promis (general health v 1.2 and fatique 7a) and PARKSLEEP. Manual and patients experience. n =6-8 patients. Go...

Testing and inventories before treatment/ at the end of the treatment and 3 months follow-up: Inventories: PHQ-4, HADS, BDQ,CFQ, PRMQ, FSS, WHODAS 2.0, SOC- 29, YSQ L3a, Compass31, Pichot, Promis (general health v 1.2 and fatique 7a) and PARKSLEEP. Manual and patients experience. n =6-8 patients. Goal is to collect patients' personal experiences about CBT- treatment. Analysis included inventories, laboratory measurements and transcribed interviews. Mixed methods (comparing statistical data and qualitative content analysis/ agency speech transformation). Therapeutic interventions and agency-speech transformation in CBT-therapy sessions. CBT- sessions are taped and transcribed. Research method: qualitative approach with discourse analysis (agency speech transformation during the intervention, therapeutical interventions in the group therapy) Randomized controlled research. n=70. Treatment/research group n=35. Control- group (35) participates on health counselling (6 sessions). Research question: is CBT-treatment clinically statistically significance. Comparison is between research- and control groups but also between patients who are diagnosed 93.3, having also objective impairment in cognitive functions or orthostatic intolerance, comparing to patients only diagnosed on G93.3.

Tracking Information

NCT #
NCT04151693
Collaborators
Not Provided
Investigators
Study Chair: Juhani Sand, professor Päijät- Häme Joint Authority for Health and Wellbeing