Condition category
Musculoskeletal Diseases
Date applied
11/07/2007
Date assigned
13/08/2007
Last edited
13/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kare Birger Hagen

ORCID ID

Contact details

National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
P.B. 23
Vinderen
Oslo
0592
Norway
+47 22454855
kbh@ulrik.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2006.3527

Study information

Scientific title

Acronym

VTP (Vitality Training Program)

Study hypothesis

Participation in the Vitality Training Program will improve psychological wellbeing, coping and health related consequences of rheumatic diseases.

Please note that details pertaining to the pilot study only will be mentioned in the relevant fields with the title 'Pilot study', and details pertaining only to the main study will be mentioned with the title 'Main study'.

Ethics approval

1. Pilot study: the pilot study was approved by the ethics committee on the 21st March 2001 (ref: 117-01041) with an extended approval to September 2002 (ref: 392-02-01041).
2. Main study: the National Committee for Medical Ethics in Norway approved this study on the 19th December 2006 (ref: 744-06316 1.2006.3527).

Study design

1. Pilot study: prospective one year follow-up study (2003 to 2005)
2. Main study: randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Rheumatic diseases

Intervention

Vitality Training is a ten-session program taught in groups with eight to ten participants. The whole program lasts for approximately four months with a booster session six months after the end of the program. Each session, lasting for four hours, addresses a specific theme, like: if the body could talk.., relation to self and others, what gives and take energy, anger, joy, sorrow and values and choices.

Through participation-based teaching and counseling methods patients are invited to become more aware of the relationship beween thoughts, feelings and bodily reactions, and further to explore own resources and potentials; with the emphasis on coping with current life situation. Exercises include awareness and relaxation training, guided imagery, moving to music, creative drawing, use of metaphors, free writing, sharing and listening to one other in small groups and homework.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Psychological Distress (General Health Questionnaire 20), this will be measured repeatedly five times before the intervention, five times after the intervention and five times one year after the intervention
2. Self-Efficacy (Arthritis Self-Efficacy Scale), this will be measured one time before the intervention (baseline), one time immediately after the intervention and at one year follow-up (12 months after baseline)
3. Emotional Approach Coping (Emotional Approach Coping Scale), this will be measured one time before the intervention (baseline), one time immediately after the intervention and at one year follow-up (12 months after baseline)

Secondary outcome measures

Symptoms: pain, fatigue, disease activity (Visual Analogue Score [VAS]-scales), this will be measured repeatedly five times before the intervention, five times after the intervention and five times one year after the intervention.

Additionally, patient characteristics of age, gender, civil status, work status, diagnosis, disease duration, drug use and use of health care will be collected at baseline. All data will be collected by self-reported questionnaires.

Overall trial start date

30/04/2007

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pilot study:
1.1. Patients with rheumatic diseases
1.2. Aged 20 to 70
1.3. Minimum disease duration one year
2. Main study:
2.1. Patients with inflammatory rheumatic diseases
2.2. Age 20 to 65
2.3. Minimum disease duration one year

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

160

Participant exclusion criteria

1. Pilot study: not speaking Norwegian language
2. Main study:
2.1. Not speaking Norwegian language
2.2. Non-inflammatory diagnosis

Recruitment start date

30/04/2007

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Norway

Trial participating centre

National Resource Center for Rehabilitation in Rheumatology
Oslo
0592
Norway

Sponsor information

Organisation

National Resource Center for Rehabilitation in Rheumatology (Norway)

Sponsor details

Diakonhjemmet Hospital
P.B. 23
Vinderen
Oslo
0592
Norway
+47 22454840
firmapost@nrrk.diakonsyk.no

Sponsor type

Hospital/treatment centre

Website

http://www.nrrk.diakonsyk.no

Funders

Funder type

Hospital/treatment centre

Funder name

National Resource Center for Rehabilitation in Rheumatology (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes