Obsessive-Compulsive DisorderNCT05105581
Psychiatric Comorbidity and Quality of Life in Patients With Obsessive Compulsive Disorder(Case Control Study )
An observational study of Obsessive-Compulsive Disorder, run by Assiut University.
Trial summary
Psychiatric Comorbidity and quality of life in patients with Obsessive Compulsive Disorder(case control study ) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Quality of life scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 May 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 1. Psychiatric interview 2. Diagnosis : according to DSM-.5 using Yale-Brown Obsessive-Compulsive Scale for diagnosis and severity 3. Psychiatric comorbidity : SCID I -SCID II scale 4. Socioeconomic state 5. Quality of life scale 6. EEG
Who may be able to join
- 1. both sex 2. age groups : 18 : 60 are included 3. accept to participate in the study
Who cannot join
- 1. presence of major neurological disease as head trauma and sensory or motor defect as blindness or deafness
- 2. Active psychiatric disordes 3. patients refuse to participate in the study
About this study
Psychiatric Comorbidity and quality of life in patients with Obsessive Compulsive Disorder(case control study )
Read the detailed description
Obsessive-compulsive disorder (OCD) is a mental and behavioral disorder[7] in which a person has certain thoughts repeatedly (called "obsessions") and/or feels the need to perform certain routines repeatedly (called "compulsions") to an extent that generates distress or impairs general functioning.[1][2] The person is unable to control either the thoughts or activities for more than a short period of time.[1] Common compulsions include excessive hand washing, the counting of things, and checking to see if a door is locked.[1] These activities occur to such a degree that the person's daily life is negatively affected,[1] often taking up more than an hour a day.[2] Most adults realize that the behaviors do not make sense.[1] The condition is associated with tics, anxiety disorder, and an increased risk of suicide.[2][3] The cause is unknown.[1] There appear to be some genetic components, with both identical twins more often affected than both non-identical twins.[2] Risk factors include a history of child abuse or other stress-inducing event.[2] Some cases have been documented to occur following infections.[2] The diagnosis is based on the symptoms and requires ruling out other drug-related or medical causes.[2] Rating scales such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) can be used to assess the severity.[8] Other disorders with similar symptoms include anxiety disorder, major depressive disorder, eating disorders, tic disorders, and obsessive-compulsive personality disorder.[2]
Treatment may involve psychotherapy, such as cognitive behavioral therapy (CBT), and antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or clomipramine.[4][5] CBT for OCD involves increasing exposure to fears and obsessions while preventing the compulsive behavior that would normally accompany the obsessions.[4] Contrary to this, metacognitive therapy encourages the ritual behaviors in order to alter the relationship to one's thoughts about them.[9] While clomipramine appears to work as well as do SSRIs, it has greater side effects and thus is typically reserved as a second-line treatment.[4] Atypical antipsychotics may be useful when used in addition to an SSRI in treatment-resistant cases but are also associated with an increased risk of side effects.[5][10] Without treatment, the condition often lasts decades.[2]
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Quality of life scale
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life scaleBehavioural
Also called Yale-Brown Obsessive-Compulsive Scale
- To assess the quality of life of patient
- To assess the degree of OCD
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Patients) | Patients: 37 patients with OCD diagnosed according to DSM-5 1. Inclusion criteria: 1. both sex 2. age groups : 18 : 60 are included 3. accept to participate in the study 2. Exclusion criteria 1. presence of major neurological disease as head trauma and sensory or motor defect as blindness or deafness 2. Active psychiatric disordes 3. patients refuse to participate in the study | |
| Group 2 (Controlled) | 37 healthy populations matched with PT group in age , sex , socioeconomic state Receives: Behavioral: Quality of life scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life scale
assess the quality of life in OCD patients
Measured: about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Safwat AbdElrhman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105581
- Sponsor's protocol ID
- Assiut Unirvesity Hospital
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Comorbidity and Quality of Life in Patients With Obsessive Compulsive Disorder(Case Control Study )
- ClinicalTrials.gov ID
- NCT05105581
- Acronym / sponsor ID
- Assiut Unirvesity Hospital
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- 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.
Psychiatric Comorbidity and quality of life in patients with Obsessive Compulsive Disorder(case control study )
Detailed description
Obsessive-compulsive disorder (OCD) is a mental and behavioral disorder[7] in which a person has certain thoughts repeatedly (called "obsessions") and/or feels the need to perform certain routines repeatedly (called "compulsions") to an extent that generates distress or impairs general functioning.[1][2] The person is unable to control either the thoughts or activities for more than a short period of time.[1] Common compulsions include excessive hand washing, the counting of things, and checking to see if a door is locked.[1] These activities occur to such a degree that the person's daily life is negatively affected,[1] often taking up more than an hour a day.[2] Most adults realize that the behaviors do not make sense.[1] The condition is associated with tics, anxiety disorder, and an increased risk of suicide.[2][3] The cause is unknown.[1] There appear to be some genetic components, with both identical twins more often affected than both non-identical twins.[2] Risk factors include a history of child abuse or other stress-inducing event.[2] Some cases have been documented to occur following infections.[2] The diagnosis is based on the symptoms and requires ruling out other drug-related or medical causes.[2] Rating scales such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) can be used to assess the severity.[8] Other disorders with similar symptoms include anxiety disorder, major depressive disorder, eating disorders, tic disorders, and obsessive-compulsive personality disorder.[2]
Treatment may involve psychotherapy, such as cognitive behavioral therapy (CBT), and antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or clomipramine.[4][5] CBT for OCD involves increasing exposure to fears and obsessions while preventing the compulsive behavior that would normally accompany the obsessions.[4] Contrary to this, metacognitive therapy encourages the ritual behaviors in order to alter the relationship to one's thoughts about them.[9] While clomipramine appears to work as well as do SSRIs, it has greater side effects and thus is typically reserved as a second-line treatment.[4] Atypical antipsychotics may be useful when used in addition to an SSRI in treatment-resistant cases but are also associated with an increased risk of side effects.[5][10] Without treatment, the condition often lasts decades.[2]
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Patients) | – | –Patients: 37 patients with OCD diagnosed according to DSM-5 1. Inclusion criteria: 1. both sex 2. age groups : 18 : 60 are included 3. accept to participate in the study 2. Exclusion criteria 1. presence of major neurological disease as head trauma and sensory or motor defect as blindness or deafness 2. Active psychiatric disordes 3. patients refuse to participate in the study |
| Group 2 (Controlled) | – | Behavioral: Quality of life scale37 healthy populations matched with PT group in age , sex , socioeconomic state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1. Psychiatric interview 2. Diagnosis : according to DSM-.5 using Yale-Brown Obsessive-Compulsive Scale for diagnosis and severity 3. Psychiatric comorbidity : SCID I -SCID II scale 4. Socioeconomic state 5. Quality of life scale 6. EEG
Key inclusion criteria (1 listed)
- 1. both sex 2. age groups : 18 : 60 are included 3. accept to participate in the study
Key exclusion criteria (2 listed)
- 1. presence of major neurological disease as head trauma and sensory or motor defect as blindness or deafness
- 2. Active psychiatric disordes 3. patients refuse to participate in the study
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 |
|---|---|---|
| Quality of life scaleAlso: Yale-Brown Obsessive-Compulsive Scale1. To assess the quality of life of patient 2. To assess the degree of OCD | Behavioural | Group 2 (Controlled) |
Primary outcome
quality of life scale
Time frame: about 6 months
assess the quality of life in OCD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
quality of life scale (time frame: about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2021.