Condition category
Mental and Behavioural Disorders
Date applied
18/12/2006
Date assigned
05/06/2007
Last edited
05/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Phillips

ORCID ID

Contact details

Beijing Hui Long Guan Hospital
Beijing
100096
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BSRPC-2

Study information

Scientific title

Acronym

IPT-China

Study hypothesis

Compared to a Treatment As Usual (TAU) group of depressed subjects, those randomly assigned to a 16-week group Interpersonal PsychoTherapy (IPT) intervention will have a significantly greater improvement in depression and anxiety symptoms at four months after enrolment (at the end of the IPT treatment) and ten months after enrolment (six months after the end of the IPT treatment).

Ethics approval

Approved by IRB of Hui Long Guan Hospital

Study design

Randomised Controlled Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major and minor depression as defined by DSM-IV diagnostic criteria

Intervention

Weekly group interpersonal psychotherapy for 16 weeks versus treatment as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes from baseline in level of depression and anxiety assessed by psychiatrists blind to the group assignment status using the Hamilton Depression Scale and the Hamilton Anxiety Scale at baseline and again at 4 months and 10 months after enrolment.

Secondary outcome measures

Changes from baseline in the following at 4 months and 10 months after enrolment:
1. Self-report psychological status, assessed by Symptoms Check List [SCL-90]
2. Hopelessness, assessed by Beck Hopelessness Scale
3. Suicidal ideation, assessed by Beck Suicidal Ideation Scale
4. Quality of Life, assessed by our own scale

Overall trial start date

07/01/2007

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Potential subjects will be identified thruough community advertisements about the psychotherapy groups and about the criteria for entry into the groups. Persons who are 18 or older who express interest in the groups will be administered a structured clinical examination (Structured Clinical Interview for DSM-IV-TR [SCID]) by an attending-level psychiatrist to determine whether or not they meet DSM-IV diagnostic criteria of major depression or minor depression. Those who meet these diagnostic criteria and are able and willing to attend 16 weekly sessions will be enrolled in the study.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Total of 120 subjects, 60 in each group

Participant exclusion criteria

1. Persons who are not residents of Huairou County
2. Current sucidal ideation and a specific plan (who will be immediately referred to the local psychiatric hospital)
3. Physical disabilities that render them unable to attend the weekly psychotherapy sessions

Recruitment start date

07/01/2007

Recruitment end date

31/05/2008

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hui Long Guan Hospital
Beijing
100096
China

Sponsor information

Organisation

Beijing Suicide Reseach and Prevention Center (China)

Sponsor details

Beijing Hui Long Guan Hospital
Beijing
100096
China

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Beijing Suicide Research and Prevention Center (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

China Medical Board of New York (Ref : 02-777)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes