Conditioning, the Placebo Effect, and Psoriasis

NCT00005922 | Completed DMC

• 2 other identifiers: R01AR046825NIAMS-051
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

This study uses the psychological principle known as classical conditioning to try to improve the standard treatment of psoriasis. Classical conditioning is a process of behavioral modification in which a person learns to connect a certain response-in this case, improvement of psoriasis-with a new action, or stimulus-in this case, application of an inactive cream. The goal of this study is to show that people with psoriasis who are maintained on corticosteroid cream part of the time and an inactive (placebo) cream at other times show a lower incidence of relapse and a reduced severity of psoriasis that patients treated with that same (reduced) amount of medication administered all the time.

Conditions

Psoriasis

Keywords

Conditioning; Corticosteroid; Lesions; Pharmacotherapy; Placebo effect; Psoriasis; Psychoneuroimmunology

Outcome Measures

Primary Outcomes (2)

• Routine and standard quantitative and qualitative assessment of plaque changes and growth

  Weekly

• Severity Index, clinically described as to redness, flaking and thickness on a total scale of 9

  Weekly

Secondary Outcomes (4)

• Impacts of Events Scale (IES)

  Once - at the initial start of the study

• Psoriasis Life Stress Inventory) (PLSI)

  Weekly

• Hassles Scale

  Weekly

• Interpersonal Support Evaluation List (ISEL)

  Once - at the intial start of the study

Study Arms (3)

A

EXPERIMENTAL

Participants will receive 100% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.

Other: Standard pharmacotherapeutic protocol

B

EXPERIMENTAL

Participants will receive 100% of the dose of the medication on a partial reinforcement schedule (25% or 50%) as received during the baseline (maintenance) period

Behavioral: Partial schedule of pharmacotherapeutic reinforcement

C

EXPERIMENTAL

Participants will receive 25% or 50% of the dose of the medication on the same reinforcement schedule (100%) as received during the baseline (maintenance) period.

Drug: Dose control for Arm B

Interventions

Partial schedule of pharmacotherapeutic reinforcement BEHAVIORAL

Dose of 0.1% of Aristocort A on 1-2 of every 4 days for a period of up to 14 weeks.

Also known as: Aristocort A

B

Dose control for Arm B DRUG

Dose of 0.025-0.05% of Aristocort A 2 times per day for a period of up to 14 weeks.

Also known as: Aristocort A

C

Standard pharmacotherapeutic protocol OTHER

Full dose of Aristicort A (0.1%) 2 times per day for a period of up to 14 weeks.

Also known as: Aristicort A

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psoriasis patients with mild to moderate lesions who are able to attend weekly clinic visits at either the University of Rochester School of Medicine and Dentistry in Rochester, NY, or Stanford University in Palo Alto, CA.
• Patients must be in good health (as determined by prescreening examination).
• Patients must not be using systemic treatment (for example, oral medications) or intralesional, UV, or topical therapies except bland emollients for at least 2 weeks before the start date of the study.
• Patients must have chronic, stable plaque psoriasis with a score of greater than or equal to 7 on a routine 9-point Severity Index.

You may not qualify if:

• Use of immunosuppressive medication within the past 2 months.
• Pregnant or sexually active women who do not use contraceptives.
• Patients who cannot be monitored regularly.
• History of allergy to corticosteroid or other study ointment components.
• Patients who have more than 10 percent of body surface area covered by psoriatic lesions.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94305, United States

Location

Adult Dermatology Clinic, Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Related Publications (4)

• Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.

  PMID: 1162023 BACKGROUND

• Ader R, Cohen N, Felten D. Psychoneuroimmunology: interactions between the nervous system and the immune system. Lancet. 1995 Jan 14;345(8942):99-103. doi: 10.1016/s0140-6736(95)90066-7. No abstract available.

  PMID: 7815892 BACKGROUND

• Giang DW, Goodman AD, Schiffer RB, Mattson DH, Petrie M, Cohen N, Ader R. Conditioning of cyclophosphamide-induced leukopenia in humans. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):194-201. doi: 10.1176/jnp.8.2.194.

  PMID: 9081556 BACKGROUND

• Ader R. "The role of conditioning in pharmacotherapy." In The placebo effect: An interdisciplinary exploration, edited by A. Harrington, 138-165. Cambridge: Harvard University Press, 1997.

  BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Robert Ader, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2000
• First Posted: June 23, 2000
• Study Start: August 1, 2000
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

US (2)