NCT01158430

Brief Summary

The purpose of this study is to determine the effect of Acceptance and Commitment Therapy (ACT) in groups on functional level, emotional problems, and use of health care in patients with severe health anxiety in a randomized, controlled design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

3.1 years

First QC Date

February 16, 2010

Last Update Submit

April 12, 2013

Conditions

HypochondriasisSomatization Disorder

Keywords

HypochondriasisAcceptance and Commitment TherapyACT

Outcome Measures

Primary Outcomes (1)

  • Health anxiety measured by the Whiteley-7 index

    9 months (2nd follow-up)

Secondary Outcomes (9)

  • Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)

    9 months (2nd follow-up)

  • Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90)

    9 months (2nd follow-up)

  • Social level of functioning measured with an alcohol dependency questionnaire (CAGE)

    9 months (2nd follow-up)

  • Illness perception measured with Illness Perception Questionnaire (IPQ)

    9 months (2nd follow-up)

  • Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)

    9 months (2nd follow-up)

  • +4 more secondary outcomes

Study Arms (2)

ACT group therapy

EXPERIMENTAL

Third generation cognitive behavioral therapy Group therapy (ACT) in groups of 9 patients in 9 weekly 3.5-hours sessions \& 1 booster session 1 month after 9th session, a total of 35.5 hours

Behavioral: ACT group therapy

Control

NO INTERVENTION

Control group assigned to wait list (treatment as usual). After 9 months they are offered ACT group therapy, but not as part of the research project.

Interventions

ACT group therapyBEHAVIORAL

Group therapy (ACT) in groups of 9 patients in 9 weekly 3.5-hours sessions \& 1 booster session 1 month after 9th session, a total of 35.5 hours

Also known as: Third generation cognitive behavioral therapy
ACT group therapy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Whiteley-7 score on 21,4 or more (scale 0-100 score points).
  • Severe health anxiety (diagnosed by SCAN interview).
  • Age 20-60 years
  • Patients of Scandinavian origin who understand, read, write and speak Danish.
  • No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
  • In case of a co morbid functional or other psychiatric disorder health anxiety must be the dominating problem.

You may not qualify if:

  • Another severe psychiatric disorder or if the patient is suicidal.
  • Abuse of narcotics or alcohol and (non-prescribed) medicine.
  • Pregnancy.
  • No informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Research Clinic for Functional Disorders, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (2)

  • Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.

    PMID: 31496462DERIVED

  • Eilenberg T, Fink P, Jensen JS, Rief W, Frostholm L. Acceptance and commitment group therapy (ACT-G) for health anxiety: a randomized controlled trial. Psychol Med. 2016 Jan;46(1):103-15. doi: 10.1017/S0033291715001579. Epub 2015 Aug 18.

    PMID: 26281857DERIVED

Related Links

MeSH Terms

Conditions

HypochondriasisSomatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Per Fink, DMSc

    The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2010

First Posted

July 8, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

DK(1)