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
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