NCT00291031

Brief Summary

The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective in the reduction of the number of nightmares and the nightmare distress in a population of patients with psychiatric disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

February 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 17, 2013

Status Verified

October 1, 2013

Enrollment Period

4.9 years

First QC Date

February 10, 2006

Last Update Submit

October 16, 2013

Conditions

NightmaresAnxiety DisordersMood DisordersPersonality Disorders

Keywords

nightmaresleep disordersleepimagery rehearsalanxiety disordersmood disorderspersonality disorders

Outcome Measures

Primary Outcomes (2)

  • Frequency of nightmares scored in prospective daily nightmare logs

    Daily logs for 18 weeks, then periods of 4 weeks every 3 months

  • Frequency of nightmares scored on the Nightmare Frequency Questionnaire

    At beginning of trial, 4, 16, 30, 42 and 56 weeks

Secondary Outcomes (8)

  • Intensity of nightmares scored in prospective daily nightmare logs

    Daily logs for 18 weeks, then periods of 4 weeks every 3 months

  • Effects of nightmares scored on the Nightmare Effects Survey

    1, 4, 16, 30, 42 and 56 weeks

  • Nightmare distress scored on the Nightmare Distress Questionnaire

    1, 4, 16, 30, 42 and 56 weeks

  • Sleep problems scored on the SLEEP-50

    1, 4, 16, 30, 42 and 56 weeks

  • Psychiatric symptoms scored on the Symptom Check List (SCL-90)

    1, 4, 16, 30, 42 and 56 weeks

  • +3 more secondary outcomes

Study Arms (2)

IRT

EXPERIMENTAL

Patients randomly assigned to the IRT condition receive Imagery Rehearsal Therapy after 4 weeks since the entrance into the trial next to their treatment as usual.

Behavioral: Imagery Rehearsal Therapy (IRT)

TAU

NO INTERVENTION

Patients that are randomly assigned to the waiting list control condition get treatment as usual (TAU) and complete the daily nightmare logs for a period of three months. These patients get the IRT intervention after waiting for 6 months.

Interventions

Imagery Rehearsal Therapy (IRT)BEHAVIORAL

Imagery Rehearsal Therapy is given by psychologists, psychotherapists or psychiatrists. The IRT therapists are all trained by Annette van Schagen, principal investigator. IRT consists of six 1-hour sessions. The six sessions are given in a period of three months. Each session is described in the IRT Manual. The IRT Manual is devised by the principal investigator Annette van Schagen in colaboration with Victor Spoormaker PhD. There is a patient version of the IRT manual available for the patients, which includes descriptions of the IRT sessions and homework assignments.

Also known as: IRT
IRT

Eligibility Criteria

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

You may qualify if:

  • Minimum of 3 nightmares per month
  • Nightmares are associated with distress in daily life
  • Subject wants to get treatment for the nightmares

You may not qualify if:

  • Imagery rehearsal therapy for nightmares in the past
  • Psychotic disorders
  • Acute psychiatric crisis
  • Mentally challenged or neuropsychiatric syndrome
  • Severe addiction problems
  • Insufficient mastery of the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GGZ Centraal, De Meregaard

Almere Stad, 1326 AD, Netherlands

Location

GGZ Centraal, Zon & Schild

Amersfoort, 3818 EW, Netherlands

Location

GGZ Centraal, De Rembrandthof

Hilversum, 1200 AE, Netherlands

Location

Related Publications (9)

  • Krakow B, Hollifield M, Johnston L, Koss M, Schrader R, Warner TD, Tandberg D, Lauriello J, McBride L, Cutchen L, Cheng D, Emmons S, Germain A, Melendrez D, Sandoval D, Prince H. Imagery rehearsal therapy for chronic nightmares in sexual assault survivors with posttraumatic stress disorder: a randomized controlled trial. JAMA. 2001 Aug 1;286(5):537-45. doi: 10.1001/jama.286.5.537.

    PMID: 11476655BACKGROUND

  • Spoormaker VI, Schredl M, van den Bout J. Nightmares: from anxiety symptom to sleep disorder. Sleep Med Rev. 2006 Feb;10(1):19-31. doi: 10.1016/j.smrv.2005.06.001. Epub 2005 Dec 27.

    PMID: 16377217BACKGROUND

  • Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. doi: 10.1001/archpsyc.1992.01820080059010.

    PMID: 1386215BACKGROUND

  • Blagrove M, Farmer L, Williams E. The relationship of nightmare frequency and nightmare distress to well-being. J Sleep Res. 2004 Jun;13(2):129-36. doi: 10.1111/j.1365-2869.2004.00394.x.

    PMID: 15175092BACKGROUND

  • Rothbaum BO, Mellman TA. Dreams and exposure therapy in PTSD. J Trauma Stress. 2001 Jul;14(3):481-90. doi: 10.1023/A:1011104521887.

    PMID: 11534880BACKGROUND

  • Spoormaker VI, Verbeek I, van den Bout J, Klip EC. Initial validation of the SLEEP-50 questionnaire. Behav Sleep Med. 2005;3(4):227-46. doi: 10.1207/s15402010bsm0304_4.

    PMID: 16190812BACKGROUND

  • Strine TW, Chapman DP. Associations of frequent sleep insufficiency with health-related quality of life and health behaviors. Sleep Med. 2005 Jan;6(1):23-7. doi: 10.1016/j.sleep.2004.06.003.

    PMID: 15680291BACKGROUND

  • van de Willige G, Wiersma D, Nienhuis FJ, Jenner JA. Changes in quality of life in chronic psychiatric patients: a comparison between EuroQol (EQ-5D) and WHOQoL. Qual Life Res. 2005 Mar;14(2):441-51. doi: 10.1007/s11136-004-0689-y.

    PMID: 15892433BACKGROUND

  • van Schagen AM, Lancee J, de Groot IW, Spoormaker VI, van den Bout J. Imagery rehearsal therapy in addition to treatment as usual for patients with diverse psychiatric diagnoses suffering from nightmares: a randomized controlled trial. J Clin Psychiatry. 2015 Sep;76(9):e1105-13. doi: 10.4088/JCP.14m09216.

    PMID: 26455674DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersMood DisordersPersonality DisordersSleep Wake Disorders

Condition Hierarchy (Ancestors)

Mental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Annette M. van Schagen, MA

    GGZ Centraal (previously Symfora groep)

    PRINCIPAL INVESTIGATOR

  • Jan van den Bout, PhD

    Utrecht University

    STUDY CHAIR

  • Victor I. Spoormaker, PhD

    Max-Planck-Institute of Psychiatry

    STUDY CHAIR

  • Jaap Lancee, PhD

    University of Amsterdam

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical psychologist

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2011

Study Completion

August 1, 2011

Last Updated

October 17, 2013

Record last verified: 2013-10

Locations

NL(3)