KATHY:Cognitive-behavioural Therapy for Hypochondriasis

NCT00208247 | Completed Phase 2

• 1 other identifier: 2001-11-DP-82-RKF-21
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis.

Conditions

Hypochondriasis

Outcome Measures

Primary Outcomes (1)

• Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).

Secondary Outcomes (1)

• Several secondary outcome measures were included 0, 6 and 12 month after treatment: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Rating Scale for Depression (HAM-D) and Global Assessment Functioning (GAF).

Study Arms (3)

CBT

EXPERIMENTAL

The cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting.

Behavioral: Cognitive behavioral psychotherapy

STPP

EXPERIMENTAL

The short-term psychodynamic psychotherapy (STPP).

Behavioral: Cognitive behavioral psychotherapy

Waiting List

EXPERIMENTAL

Patients in the waiting-list group were asked to keep in touch with their GP, who had been informed of the trial in writing. The patients and their GPs were instructed not to begin any other treatment during the study period. After 6 months, the patients on the waiting list were re-evaluated for inclusion and exclusion criteria and, if they still met the criteria, re-randomized to CBT or STPP.

Behavioral: Cognitive behavioral psychotherapy

Interventions

Cognitive behavioral psychotherapy BEHAVIORAL

CBT; STPP; Waiting List

Eligibility Criteria

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

You may qualify if:

• (1) age between 18 and 65 years, (2) Danish as native language, (3) fulfilment of the ICD-10 research criteria for hypochondriasis (3), (4) health anxiety to a significant degree: a score more than 17 on the health anxiety inventory (HAI) (5).

You may not qualify if:

• (1) current psychotic condition, (2) current substance abuse, (3) a medical condition which demanded immediate treatment, (4) psychopharmacological treatment initiated or increased during the last 6 weeks before treatment, and (5) previous cognitive behavioural treatment.

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research: lead
• Bispebjerg Hospital: collaborator

MeSH Terms

Conditions

Hypochondriasis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Morten Birket-Smith, DMSc

  Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark

  STUDY DIRECTOR

• Per Sorensen, MD

  Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2001
• Primary Completion: January 1, 2003
• Study Completion: March 1, 2005
• Last Updated: August 11, 2016

Record last verified: 2016-08