Giardia Induced Fatigue and Functional Gastrointestinal Diseases

NCT00860236 | Completed Phase 4

• 1 other identifier: GIFF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance:

• Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae.
• Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors.
• Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.

Conditions

Chronic Fatigue Syndrome

Keywords

CFS; Giardia; Fatigue; Cognitive behavioural therapy; CBT; Chronic fatigue syndrome

Outcome Measures

Primary Outcomes (1)

• Improvement minimum 6 points in Chalder Fatigue scale score

  6 months

Study Arms (2)

Psycoeducation/counseling

ACTIVE COMPARATOR

Other: Psycoeducation/counseling

Cognitive behavioural therapy

ACTIVE COMPARATOR

Behavioral: Cognitive behavioural therapy

Interventions

Psycoeducation/counseling OTHER

2 days of education on mechanisms of illness and coping strategies

Psycoeducation/counseling

Cognitive behavioural therapy BEHAVIORAL

4 days intensive training in understanding and behavioural changes

Also known as: CBT

Cognitive behavioural therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Problems with fatigue of any severity after Giardia infection

Sponsors & Collaborators

• University of Bergen: lead

Study Sites (1)

Frihamnsenteret

Skånevik, Norway

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Giardiasis; Fatigue

Interventions

Counseling; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Study Officials

• Bjarte Stubhaug, PhD

  Frihamnsenteret

  STUDY DIRECTOR

• Nina Langeland, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

NO (1)