Mental HealthNCT01155687
Psychosocial Counseling in Afghanistan
An observational study of Mental Health and Stress, run by University of Konstanz at 1 site in Afghanistan.
Trial summary
The assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Mental Health, Stress
- How many people
- 61 participants
- Where
- 1 siteAfghanistan
- Study dates
- Sep 2009to Jul 2010
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Afghan people at primary care clinic seeking help because of mental health problems
Who may be able to join
- Diagnosis of mental health problems by a local medical doctor
Who cannot join
- Schizophrenia
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
The assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training
Read the detailed description
Psychosocial stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with ongoing war-like conditions. There is a lack of intervention research in these population. The purpose of this assessment was to examine whether the type of psychosocial counseling developed by our group is effective in reducing symptoms of depression and anxiety and significantly increasing the quality of life of help-seeking Afghans.
- Conditions
- Mental Health, Stress
- Keywords
- afghanistan, depression, anxiety, social stress, counseling, medication, psychotherapy, mental health
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial counseling | the group received annualized treatment of psychosocial counseling | |
| Medication | this group received medical treatment by the local medical doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSCL 25
Symptoms of Depression and Anxiety measured with the HSCL 25
Measured: Symptoms were assessed at baseline
HSCL 25
Symptoms of Depression and Anxiety measured with the HSCL 25
Measured: 3-month follow-up
HSCL 25
Symptoms of Depression and Anxiety measured with the HSCL 25
Measured: Assessment at 12-month-follow-up
Secondary outcomes (9)
M.I.N.I. (Mini-International Neuropsychiatric Interview)
To assess, if the patients have a current Major Depression, the depression section from the "Mini-International Neuropsychiatric Interview" (Sheehan, \& Janavs, 1998) was included
Measured: Symptoms were assessed at baseline
Psychosocial stressors and coping mechanism
Psychosocial stressors and coping mechanism of the participants were investigated in expert interviews
Measured: Symptoms were assessed at baseline
Screening for Depression
A culturally grounded assessment measure developed in close collaboration with a team of Afghan experts explored current depressive symptoms
Measured: Symptoms were assessed at baseline
M.I.N.I. (Mini-International Neuropsychiatric Interview)
To assess, if the patients have a current Major Depression, the depression section from the "Mini-International Neuropsychiatric Interview" (Sheehan, \& Janavs, 1998) was included
Measured: Assessment at 3-month-follow-up
M.I.N.I (Mini-International Neuropsychiatric Interview)
To assess, if the patients have a current Major Depression, the depression section from the "Mini-International Neuropsychiatric Interview" (Sheehan, \& Janavs, 1998) was included
Measured: Assessment at 12-month-follow-up
Psychosocial stressors and coping mechanism
Psychosocial stressors and coping mechanism of the participants were investigated in expert interviews
Measured: Assessment at 3-month-follow-up
Psychosocial stressors and coping mechanism
Psychosocial stressors and coping mechanism of the participants were investigated in expert interviews
Measured: Assessment at 12-month-follow-up
Screening for Depression
A culturally grounded assessment measure developed in close collaboration with a team of Afghan experts explored current depressive symptoms
Measured: Assessment at 3-month-follow-up
Screening for Depression
A culturally grounded assessment measure developed in close collaboration with a team of Afghan experts explored current depressive symptoms
Measured: Assessment at 12-month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
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 Mental HealthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Investigators
- Thomas Elbert, Dr., Principal investigator, University of KonstanzSarah Ayoughi, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155687
- Sponsor's protocol ID
- EuropeAid/127054/C/SER/MULTI
- Status last verified
- Jun 2010
- First submitted
- 30 Jun 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ayoughi S, Missmahl I, Weierstall R, Elbert T. Provision of mental health services in resource-poor settings: a randomised trial comparing counselling with routine medical treatment in North Afghanistan (Mazar-e-Sharif). BMC Psychiatry. 2012 Feb 29;12:14. doi: 10.1186/1471-244X-12-14.
PubMed 22375947
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Counseling in Afghanistan
- ClinicalTrials.gov ID
- NCT01155687
- Acronym / sponsor ID
- EuropeAid/127054/C/SER/MULTI
- Conditions
- Mental Health, Stress
- Keywords
- afghanistan, depression, anxiety, social stress, counseling, medication, psychotherapy, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Jul 2010 (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 assessment intends to investigate the efficacy of psychosocial counseling for the treatment of help seeking individuals with psychosocial problems in Mazar-e-Sharif, Afghanistan. Treatment was administered by local counselors who had received specific education and training
Detailed description
Psychosocial stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with ongoing war-like conditions. There is a lack of intervention research in these population. The purpose of this assessment was to examine whether the type of psychosocial counseling developed by our group is effective in reducing symptoms of depression and anxiety and significantly increasing the quality of life of help-seeking Afghans.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial counseling | – | –the group received annualized treatment of psychosocial counseling |
| Medication | – | –this group received medical treatment by the local medical doctor |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Afghan people at primary care clinic seeking help because of mental health problems
Key inclusion criteria (1 listed)
- Diagnosis of mental health problems by a local medical doctor
Key exclusion criteria (2 listed)
- Schizophrenia
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HSCL 25
Time frame: Symptoms were assessed at baseline
Symptoms of Depression and Anxiety measured with the HSCL 25
HSCL 25
Time frame: 3-month follow-up
Symptoms of Depression and Anxiety measured with the HSCL 25
HSCL 25
Time frame: Assessment at 12-month-follow-up
Symptoms of Depression and Anxiety measured with the HSCL 25
9 secondary outcomes
M.I.N.I. (Mini-International Neuropsychiatric Interview)
Time frame: Symptoms were assessed at baseline
Psychosocial stressors and coping mechanism
Time frame: Symptoms were assessed at baseline
Screening for Depression
Time frame: Symptoms were assessed at baseline
M.I.N.I. (Mini-International Neuropsychiatric Interview)
Time frame: Assessment at 3-month-follow-up
M.I.N.I (Mini-International Neuropsychiatric Interview)
Time frame: Assessment at 12-month-follow-up
Psychosocial stressors and coping mechanism
Time frame: Assessment at 3-month-follow-up
Psychosocial stressors and coping mechanism
Time frame: Assessment at 12-month-follow-up
Screening for Depression
Time frame: Assessment at 3-month-follow-up
Screening for Depression
Time frame: Assessment at 12-month-follow-up
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 9 Aug 2011.
- Derived from this study: PubMed 22375947Ayoughi S, Missmahl I, Weierstall R, Elbert T. Provision of mental health services in resource-poor settings: a randomised trial comparing counselling with routine medical treatment in North Afghanistan (Mazar-e-Sharif). BMC Psychiatry. 2012 Feb 29;12:14. doi: 10.1186/1471-244X-12-14.
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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.
Thomas Elbert, Dr. principal investigator
University of Konstanz
Sarah Ayoughi principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Stress, run by University of Konstanz at 1 site in Afghanistan.
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 1 inclusion and 2 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 9 Aug 2011. 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 Afghanistan. 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?
HSCL 25 (time frame: Symptoms were assessed at baseline). The study lists 3 primary outcomes in all. 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 NCT01155687, 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 9 Aug 2011.