Randomised controlled trial of group Interpersonal PsychoTherapy with depressed community members in a rural township in Huairou County, Beijing
| ISRCTN | ISRCTN40122815 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40122815 |
| Secondary identifying numbers | BSRPC-2 |
- Submission date
- 18/12/2006
- Registration date
- 05/06/2007
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Phillips
Scientific
Scientific
Beijing Hui Long Guan Hospital
Beijing
100096
China
Study information
| Study design | Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Randomised controlled trial of group Interpersonal PsychoTherapy with depressed community members in a rural township in Huairou County, Beijing |
| Study acronym | IPT-China |
| Study objectives | 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(s) | Approved by IRB of Hui Long Guan Hospital |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/01/2007 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Total of 120 subjects, 60 in each group |
| Key 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. |
| Key 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 |
| Date of first enrolment | 07/01/2007 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing Hui Long Guan Hospital
Beijing
100096
China
100096
China
Sponsor information
Beijing Suicide Reseach and Prevention Center (China)
Research organisation
Research organisation
Beijing Hui Long Guan Hospital
Beijing
100096
China
Funders
Funder type
Research organisation
Beijing Suicide Research and Prevention Center (China)
No information available
China Medical Board of New York (Ref : 02-777)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/10/2021: Proactive update review. No publications found. Search options exhausted.
