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Completed

NCT Number: NCT02003261

Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)

This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.

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Key information

Conditions

Anxiety Disorders Depressive Disorder Depressive Disorders Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

About this study

Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.
  • Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8).
  • Ages 20 years or older, and 65 years or younger at screening.
  • Subjects who give full consent in the participation of the study.

Exclusion criteria

  • No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID
  • No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID
  • No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
  • No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
  • Evidence of unable to participate half or more of the intervention phase.
  • No structured psychotherapy during at baseline.
  • Other relevant reason decided by the investigators.

Treatment and study plan

Unified Protocol with Treatment As Usual

Behavioral

Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university.

UP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure.

Other names: Cognitive Behavioral Therapy

Treatment as Usual

Other

Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.

Primary outcomes

  1. GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)

    Time frame: 21 weeks

Secondary outcomes

  1. Hamilton Anxiety Rating Scale 14 item(HAM-A)

    Time frame: 21 weeks

  2. Clinical Global Impression- Severity(CGI-S)

    Time frame: 21 weeks

  3. Clinical Global Impression-Improvement(CGI-I)

    Time frame: 21 weeks

  4. Responder Status assessed by GRID-HAMD

    Time frame: 21 weeks

    Reduction in GRID-HAMD score of at least 50% compared with baseline

  5. Remission of symptoms assessed by GRID-HAMD

    Time frame: 21 weeks

    GRID-HAMD score of less than 8

  6. Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)

    Time frame: 21 weeks

Other outcomes

  1. Global Assessment of Functioning(GAF)

    Time frame: 10 weeks, 21 weeks, and 43 weeks

  2. Disorder specific measures

    Time frame: 10 weeks, 21 weeks, and 43 weeks

    Participants will be answered some of the following measures in accord with their diagnoses; Beck Depression Inventory-II for Depressive Disorders, Panic Disorder Severity Scale for Panic Disorder, Penn-State Worry Questionnaire for Generalized Anxiety Disorder, Impact of Event Scale-Revised for Post-Traumatic Stress Disorder, Yale-Brown Obsessive Compulsive Scale for Obsessive Compulsive Disorder and Fear Questionnaire for Agora Phobia.

  3. Quality of Life(EQ-5D)

    Time frame: 10 weeks, 21 weeks, and 43 weeks

  4. Sheehan Disability Scale(SDISS)

    Time frame: 10 weeks, 21 weeks, and 43 weeks

  5. Sense of Authenticity Scale(SOA)

    Time frame: 10 weeks, 21 weeks, and 43 weeks

  6. Overall Anxiety Severity and Impairment Scale(OASIS)

    Time frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions

  7. Overall Depression Severity and Impairment Scale(ODSIS)

    Time frame: 10 weeks, 21 weeks, 43 weeks and at every UP sessions

  8. Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)

    Time frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15

  9. Anxiety Sensitivity Index-III(ASI-III)

    Time frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15

  10. Emotion Regulation Skills Questionnaire(ERSQ)

    Time frame: 10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15

  11. Credibility/Expectancy Questionnaire(CEQ)

    Time frame: 2 weeks

  12. Session Rating Scale(SRS V.3.0)

    Time frame: UP session at #1, 5, 10, and 15

  13. Homework Compliance Scale(HCS)

    Time frame: UP session at #1, 5, 10, and 15

  14. Adverse Events

    Time frame: From 1 week to 21 weeks

    Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

  15. GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)

    Time frame: 10 weeks, 43 weeks

  16. Hamilton Anxiety Rating Scale 14 item(HAM-A)

    Time frame: 10 weeks and 43 weeks

  17. Clinical Global Impression- Severity(CGI-S)

    Time frame: 10 weeks, 43 weeks

  18. Clinical Global Impression-Improvement(CGI-I)

    Time frame: 10 weeks, 43 weeks

  19. Psychiatric diagnosis assessed by SCID

    Time frame: 43 weeks

  20. Emotion Exposure Scale (EES)

    Time frame: 10 weeks, 21 weeks, 43 weeks

  21. Understanding of Treatment Rational of Unified Protocol (TRUP)

    Time frame: 10 weeks, 21 weeks, and 43 weeks

  22. Magnetic Resonance Imaging(MRI)

    Time frame: 21 weeks, 43 weeks

Sponsors and collaborators

Lead sponsor

National Center of Neurology and Psychiatry, Japan

Other

Registry information

Official study title

An Assessor-blinded, Randomized, 20-week, Parallel-group, Superiority Study to Compare the Efficacy of Transdiagnostic Cognitive Behavioral Therapy Versus Waiting-list in Depressive and Anxiety Symptoms of Depressive and Anxiety Disorders

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Dec 6, 2013
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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