Psychologic ManipulationPhase 1NCT03469128
Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients
A Phase 1 study testing Cognitive processing therapy and Sertraline in people with Psychologic Manipulation, run by British University In Egypt.
Trial summary
The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD \& SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychologic Manipulation
- What is being tested?
- Cognitive processing therapy and Sertraline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2020
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with SUD
Who cannot join
- Patients diagnosed with other psychotic disorders
About this study
Official title: Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients
The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD \& SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD.
Read the detailed description
Patients with co-occurrence PTSD \& SUD disorders were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: were treated by Sertraline. Third: a placebo control group.
- Conditions
- Psychologic Manipulation
- Being tested
- Cognitive processing therapy, Sertraline, Placebo Control
- Keywords
- PTSD, CPT, SUD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive processing therapyBehavioural
Psychological treatment for patients suffering from PTSD and SUD symptoms.
SertralineDrug
Also called SSRI
Sertraline for the treatment of post-traumatic stress and SU disorders
Placebo ControlOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Cognitive processing therapy | Active comparator | Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT Receives: Behavioral: Cognitive processing therapy |
| Sertraline | Active comparator | Patients with co-occurrence PTSD \& SUD disorders were treated by Sertraline. Receives: Drug: Sertraline |
| Control group | Placebo comparator | Placebo Control group Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
A psychological parameter will be measured to check the efficacy of CPT against medication for the treatment for co-current PTSD \& SUD. The groups will be examined to show if any significant reductions in PTSD and SUD symptoms was obtained over time.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Jan 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychologic ManipulationStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Data were obtained by interviewing 587 patients diagnosed with SUD. Patients were interviewed by a clinician and asked to complete: Mini-International Neuropsychiatric Interview (M.I.N.I), and Clinician-Administered PTSD Scale (CAPS). Patients with comorbid SUD and PTSD were asked to complete: The Brief Addiction Monitor (BAM), PTSD Checklist-Civilian (PCL-5), Beck Depression Inventory (BDI-II), and Timeline Follow Back Interview (TLFB). Patients with comorbid SUD and PTSD were randomized to one of the following groups: 1) received CPT. 2) received Sertraline. 3) the Placebo control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Safwat Albrazi, British University In Egypt
- Investigators
- Amani Elbarazi, Ph.D., Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469128
- Sponsor's protocol ID
- 2016-2017PTBUE
- Other IDs
- IRB Protocol CL-006
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients
- ClinicalTrials.gov ID
- NCT03469128
- Acronym / sponsor ID
- 2016-2017PTBUE
- Conditions
- Psychologic Manipulation
- Keywords
- PTSD, CPT, SUD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Mar 2018 (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.
The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD \& SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD.
Detailed description
Patients with co-occurrence PTSD \& SUD disorders were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: were treated by Sertraline. Third: a placebo control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Data were obtained by interviewing 587 patients diagnosed with SUD. Patients were interviewed by a clinician and asked to complete: Mini-International Neuropsychiatric Interview (M.I.N.I), and Clinician-Administered PTSD Scale (CAPS). Patients with comorbid SUD and PTSD were asked to complete: The Brief Addiction Monitor (BAM), PTSD Checklist-Civilian (PCL-5), Beck Depression Inventory (BDI-II), and Timeline Follow Back Interview (TLFB). Patients with comorbid SUD and PTSD were randomized to one of the following groups: 1) received CPT. 2) received Sertraline. 3) the Placebo control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive processing therapy | Active comparator | Behavioral: Cognitive processing therapyCognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT |
| Sertraline | Active comparator | Drug: SertralinePatients with co-occurrence PTSD \& SUD disorders were treated by Sertraline. |
| Control group | Placebo comparator | Other: Placebo ControlPlacebo Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with SUD
Key exclusion criteria (1 listed)
- Patients diagnosed with other psychotic disorders
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 therapyPsychological treatment for patients suffering from PTSD and SUD symptoms. | Behavioural | Cognitive processing therapy |
| SertralineAlso: SSRISertraline for the treatment of post-traumatic stress and SU disorders | Drug | Sertraline |
| Placebo ControlPlacebo Control | Other | Control group |
Primary outcome
Questionnaire
Time frame: 3 Months
A psychological parameter will be measured to check the efficacy of CPT against medication for the treatment for co-current PTSD \& SUD. The groups will be examined to show if any significant reductions in PTSD and SUD symptoms was obtained over time.
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 Apr 2021.
- Individual participant dataSharing planned: Undecided
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.
Amani Elbarazi, Ph.D. principal investigator
British University In Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive processing therapy and Sertraline in people with Psychologic Manipulation, run by British University In Egypt.
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 1 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 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Questionnaire (time frame: 3 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 1 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.