DepressionNCT00925262
Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan
A study testing Cognitive Processing Therapy, Behavioral Activation and nonspecific counseling in people with Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Iraq.
Trial summary
The purpose of this study is to determine the relative effectiveness of three different mental health counseling interventions in the treatment of mental health problems commonly affecting torture and trauma survivors living in Kurdistan, Iraq. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Processing Therapy, Behavioral Activation and nonspecific counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteIraq
- Study dates
- Jun 2009to Oct 2011
- 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
- at least 18 years old
- Kurdish
- torture survivor
- currently has significant depression symptomatology.
Who cannot join
- danger to self or others
- already receiving treatment from our treatment provider
- not mentally competent to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
multiple public health clinics across Kurdistan
Dohuk, Sulaimani, Erbil, Rural Areas, ALL
About this study
Official title: A Controlled Trial of Mental Health Interventions for Common Mental Health Problems Experienced by Torture Survivors Living in Kurdistan, Iraq.
The purpose of this study is to determine the relative effectiveness of three different mental health counseling interventions in the treatment of mental health problems commonly affecting torture and trauma survivors living in Kurdistan, Iraq.
Read the detailed description
See above
- Conditions
- Depression
- Being tested
- Cognitive Processing Therapy, Behavioral Activation, nonspecific counseling
- Keywords
- mental health, randomized controlled trial, torture
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT
an adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure
Behavioral ActivationBehavioural
Also called BA
form of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity
nonspecific counselingBehavioural
nonspecific counseling interventions useful for a broad range of mental health and psychosocial problems.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy | Experimental | An adaptation of cognitive behavioral therapy, focusing on treatment for persons suffering mental health effects of trauma Receives: Behavioral: Cognitive Processing Therapy |
| Behavioral Activation | Experimental | A form of counseling therapy that emphasizes enhancing pleasurable behaviors and minimizing negative behaviors as a means to reducing depression symptomatology. Receives: Behavioral: Behavioral Activation |
| non-specific counseling | Experimental | a collection of counseling skills suitable for a broad range of mental health and psychosocial problems and not designed for specific disorders. This particular version was developed by a collaborator -Heartland Alliance - for use with torture survivors. Receives: Behavioral: nonspecific counseling |
| wait control | No intervention | persons in this study arm will not receive active treatment as part of the study but will be monitored during the study and offered treatment after 3-5 months of waiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression symptom severity
Measured: 3-6 months
Secondary outcomes (4)
ability to carry out routine tasks and activities
Measured: 3-6 months
anxiety symptom severity
Measured: 3-6 months
posttraumatic stress disorder symptom severity
Measured: 3-6 months
traumatic grief symptom severity
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionOct 2011
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 DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Bolton, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Paul A Bolton, MB BS, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925262
- Sponsor's protocol ID
- BoltonP-1
- Status last verified
- May 2013
- First submitted
- 3 Jun 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bolton P, Bass JK, Zangana GA, Kamal T, Murray SM, Kaysen D, Lejuez CW, Lindgren K, Pagoto S, Murray LK, Van Wyk SS, Ahmed AM, Amin NM, Rosenblum M. A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan, Northern Iraq. BMC Psychiatry. 2014 Dec 31;14:360. doi: 10.1186/s12888-014-0360-2.
PubMed 25551436
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Mental Health Interventions for Common Mental Health Problems Experienced by Torture Survivors Living in Kurdistan, Iraq.
- ClinicalTrials.gov ID
- NCT00925262
- Acronym / sponsor ID
- BoltonP-1
- Conditions
- Depression
- Keywords
- mental health, randomized controlled trial, torture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 2009 (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 purpose of this study is to determine the relative effectiveness of three different mental health counseling interventions in the treatment of mental health problems commonly affecting torture and trauma survivors living in Kurdistan, Iraq.
Detailed description
See above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing TherapyAn adaptation of cognitive behavioral therapy, focusing on treatment for persons suffering mental health effects of trauma |
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationA form of counseling therapy that emphasizes enhancing pleasurable behaviors and minimizing negative behaviors as a means to reducing depression symptomatology. |
| non-specific counseling | Experimental | Behavioral: nonspecific counselinga collection of counseling skills suitable for a broad range of mental health and psychosocial problems and not designed for specific disorders. This particular version was developed by a collaborator -Heartland Alliance - for use with torture survivors. |
| wait control | No intervention | –persons in this study arm will not receive active treatment as part of the study but will be monitored during the study and offered treatment after 3-5 months of waiting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- Kurdish
- torture survivor
- currently has significant depression symptomatology.
Key exclusion criteria (3 listed)
- danger to self or others
- already receiving treatment from our treatment provider
- not mentally competent to provide informed consent.
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 |
|---|---|---|
| Cognitive Processing TherapyAlso: CPTan adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure | Behavioural | Cognitive Processing Therapy |
| Behavioral ActivationAlso: BAform of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity | Behavioural | Behavioral Activation |
| nonspecific counselingnonspecific counseling interventions useful for a broad range of mental health and psychosocial problems. | Behavioural | non-specific counseling |
Primary outcome
depression symptom severity
Time frame: 3-6 months
4 secondary outcomes
ability to carry out routine tasks and activities
Time frame: 3-6 months
anxiety symptom severity
Time frame: 3-6 months
posttraumatic stress disorder symptom severity
Time frame: 3-6 months
traumatic grief symptom severity
Time frame: 3-6 months
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 3 May 2013.
- Derived from this study: PubMed 25551436Bolton P, Bass JK, Zangana GA, Kamal T, Murray SM, Kaysen D, Lejuez CW, Lindgren K, Pagoto S, Murray LK, Van Wyk SS, Ahmed AM, Amin NM, Rosenblum M. A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan, Northern Iraq. BMC Psychiatry. 2014 Dec 31;14:360. doi: 10.1186/s12888-014-0360-2.
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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.
Paul A Bolton, MB BS principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy, Behavioral Activation and nonspecific counseling in people with Depression, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Iraq.
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 3 May 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 Iraq. 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?
depression symptom severity (time frame: 3-6 months). 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 NCT00925262, 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 3 May 2013.