Anxiety DisordersNCT02003261
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
A study testing Unified Protocol with Treatment As Usual and Treatment As Usual in people with Anxiety Disorders and Depressive Disorders, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders
- What is being tested?
- Unified Protocol with Treatment As Usual and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jan 2014to 5 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Anxiety Disorders, Depressive Disorders
- Being tested
- Unified Protocol with Treatment As Usual, Treatment As Usual
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol with Treatment As UsualBehavioural
Also called Cognitive Behavioral Therapy
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.
Treatment As UsualOther
Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol with Treatment As Usual | Experimental | Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual. Receives: Behavioral: Unified Protocol with Treatment As Usual; Other: Treatment As Usual |
| Waitlist Control with Treatment As Usual | Other | Waitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Measured: 21 weeks
Secondary outcomes (6)
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Measured: 21 weeks
Clinical Global Impression- Severity(CGI-S)
Measured: 21 weeks
Clinical Global Impression-Improvement(CGI-I)
Measured: 21 weeks
Responder Status assessed by GRID-HAMD
Reduction in GRID-HAMD score of at least 50% compared with baseline
Measured: 21 weeks
Remission of symptoms assessed by GRID-HAMD
GRID-HAMD score of less than 8
Measured: 21 weeks
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study start31 Jan 2014
- Primary completion2 Nov 2018
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masaya ITO, National Center of Neurology and Psychiatry, Japan
- Investigators
- Masaya Ito, Ph.D., Principal investigator, National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003261
- Sponsor's protocol ID
- KAKENHI 25705018
- Status last verified
- Aug 2019
- First submitted
- 2 Dec 2013
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, Hirabayashi N, Kanie A, Nakagawa A, Ono Y. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Mar 18;16:71. doi: 10.1186/s12888-016-0779-8.
PubMed 26987315
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02003261
- Acronym / sponsor ID
- KAKENHI 25705018
- Conditions
- Anxiety Disorders, Depressive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Center of Neurology and Psychiatry, JapanUniversity, hospital or other
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol with Treatment As Usual | Experimental | Behavioral: Unified Protocol with Treatment As Usual, Other: Treatment As UsualUnified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual. |
| Waitlist Control with Treatment As Usual | Other | Other: Treatment As UsualWaitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol with Treatment As UsualAlso: Cognitive Behavioral TherapyUnified 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. | Behavioural | Unified Protocol with Treatment As Usual |
| Treatment As UsualMost of the TAU will be drug therapy or nonsystematic supportive psychotherapy. | Other | Unified Protocol with Treatment As Usual, Waitlist Control with Treatment As Usual |
Primary outcome
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time frame: 21 weeks
6 secondary outcomes
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time frame: 21 weeks
Clinical Global Impression- Severity(CGI-S)
Time frame: 21 weeks
Clinical Global Impression-Improvement(CGI-I)
Time frame: 21 weeks
Responder Status assessed by GRID-HAMD
Time frame: 21 weeks
Remission of symptoms assessed by GRID-HAMD
Time frame: 21 weeks
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 26987315Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, Hirabayashi N, Kanie A, Nakagawa A, Ono Y. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Mar 18;16:71. doi: 10.1186/s12888-016-0779-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaya Ito, Ph.D. principal investigator
National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol with Treatment As Usual and Treatment As Usual in people with Anxiety Disorders and Depressive Disorders, run by National Center of Neurology and Psychiatry, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.