Posttraumatic Stress DisorderNCT01624935
Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
A study testing interpersonal psychotherapy in people with Posttraumatic Stress Disorder and Depression, run by University of California, San Francisco at 1 site in China.
Trial summary
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years;
- diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
- Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
- Ability to give verbal informed consent
Who cannot join
- Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
- Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
- drug and alcohol dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.
Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.
Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.
Read the detailed description
Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- interpersonal psychotherapy
- Keywords
- PTSD, earthquake, disaster, global mental health, disaster mental health, depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpersonal psychotherapyBehavioural
interpersonal psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| psychotherapy | Experimental | psychotherapy Receives: Behavioral: interpersonal psychotherapy |
| treatment as usual | Other | TAU control Receives: Behavioral: interpersonal psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
Measured: baseline through week 24
Secondary outcomes (1)
Standard Clinical Interview for DSM IV Diagnosis (SCID)
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
Measured: baseline through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
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 Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Meffert, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624935
- Sponsor's protocol ID
- 10-02408
- Status last verified
- Sep 2013
- First submitted
- 7 Feb 2012
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang RF, Tong HQ, Delucchi KL, Neylan TC, Shi Q, Meffert SM. Interpersonal psychotherapy versus treatment as usual for PTSD and depression among Sichuan earthquake survivors: a randomized clinical trial. Confl Health. 2014 Sep 4;8:14. doi: 10.1186/1752-1505-8-14. eCollection 2014.
PubMed 25254070
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
- ClinicalTrials.gov ID
- NCT01624935
- Acronym / sponsor ID
- 10-02408
- Conditions
- Posttraumatic Stress Disorder, Depression
- Keywords
- PTSD, earthquake, disaster, global mental health, disaster mental health, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Jun 2012 (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.
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.
Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.
Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.
Detailed description
Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotherapy | Experimental | Behavioral: interpersonal psychotherapypsychotherapy |
| treatment as usual | Other | Behavioral: interpersonal psychotherapyTAU control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years;
- diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
- Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
- Ability to give verbal informed consent
Key exclusion criteria (3 listed)
- Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
- Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
- drug and alcohol dependence
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 |
|---|---|---|
| interpersonal psychotherapyinterpersonal psychotherapy | Behavioural | psychotherapy, treatment as usual |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: baseline through week 24
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
1 secondary outcome
Standard Clinical Interview for DSM IV Diagnosis (SCID)
Time frame: baseline through week 24
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 1 Oct 2013.
- Derived from this study: PubMed 25254070Jiang RF, Tong HQ, Delucchi KL, Neylan TC, Shi Q, Meffert SM. Interpersonal psychotherapy versus treatment as usual for PTSD and depression among Sichuan earthquake survivors: a randomized clinical trial. Confl Health. 2014 Sep 4;8:14. doi: 10.1186/1752-1505-8-14. eCollection 2014.
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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.
Susan Meffert, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpersonal psychotherapy in people with Posttraumatic Stress Disorder and Depression, run by University of California, San Francisco at 1 site in China.
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 3 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 1 Oct 2013. 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 China. 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?
Clinician Administered PTSD Scale (CAPS) (time frame: baseline through week 24). 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 NCT01624935, 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 1 Oct 2013.