NCT01119469

Brief Summary

This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

4.2 years

First QC Date

May 5, 2010

Last Update Submit

August 5, 2014

Conditions

Keywords

HypochondriasisHealth Anxietyrandomized controlled trialCognitive TherapyExposure Therapy

Outcome Measures

Primary Outcomes (1)

  • Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)

    clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance

    3 months

Secondary Outcomes (7)

  • Illness Attitude Scales (IAS)

    3 months

  • Beck-Depression Inventory II (BDI-II)

    3 months

  • Beck Anxiety Inventory (BAI)

    3 months

  • Brief Symptom Inventory (BSI)

    3 months

  • Scale for the Assessment of Illness Behavior (SAIB)

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Cognitive Therapy (CT)

EXPERIMENTAL

There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention.

Behavioral: Psychotherapy (CT or ET)

Exposure Therapy (ET)

EXPERIMENTAL

There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include change of safety behavior, exposition (in sensu and in vivo), and response prevention.

Behavioral: Psychotherapy (CT or ET)

Waiting List (WL)

NO INTERVENTION

12 weeks waiting time

Interventions

weekly 50-minute sessions for 12 weeks

Also known as: Cognitive Therapy, Exposure Therapy
Cognitive Therapy (CT)Exposure Therapy (ET)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for hypochondriasis
  • German fluency and literacy
  • Informed consent

You may not qualify if:

  • Major medical illness expected to worsen significantly
  • Currently in psychotherapy
  • Suicidal tendency
  • Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University

Frankfurt am Main, Hesse, D-60486, Germany

Location

MeSH Terms

Conditions

HypochondriasisSomatoform Disorders

Interventions

PsychotherapyCognitive Behavioral TherapyImplosive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesBehavior TherapyDesensitization, Psychologic

Study Officials

  • Florian Weck, PhD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 7, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations