Obsessive-compulsive Disorders and SymptomsNCT04575805
Internet-delivered CBM-C for OC-symptoms
A study testing Internet-delivered Combined Cognitive Bias Modification (iCBM-C), Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I) and Internet-delivered Cognitive Bias Modification-Attention (iCBM-A) in people with Obsessive-compulsive Disorders and Symptoms and Obsessive Thoughts, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
A factorial randomised controlled trial comparing internet-delivered combined cognitive bias modification intervention (iCBM-C) versus internet-delivered CBM-interpretation intervention (iCBM-I), internet-delivered CBM-attention intervention (iCBM-A) and wait-list control on obsessive-compulsive (OC) symptoms… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obsessive-compulsive Disorders and Symptoms, Obsessive Thoughts, Obsessive Compulsive Behavior
- What is being tested?
- Internet-delivered Combined Cognitive Bias Modification (iCBM-C), Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I) and Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 1 Mar 2021
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fluent in written and spoken Turkish
- Daily access to the internet by computer
- No participation on any other interventional study or clinical trial
- The presence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores > 65.81).
Who cannot join
- The absence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores < 65.81)
- Suicidal ideation and severe psychotic symptoms (a rating of slight (i.e., 1) or greater on any item within the domain based on their responses to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version
- No access to the internet and computer
- Color blindness
- A current diagnosis of neurological and psychiatric disorder
- Ongoing psychological/psychiatric treatment
- Ongoing participation in other interventional study or clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Combined Cognitive Bias Modification (iCBM-C) in People With High Obsessive Compulsive Symptoms: A Factorial Randomised Controlled Trial
A factorial randomised controlled trial comparing internet-delivered combined cognitive bias modification intervention (iCBM-C) versus internet-delivered CBM-interpretation intervention (iCBM-I), internet-delivered CBM-attention intervention (iCBM-A) and wait-list control on obsessive-compulsive (OC) symptoms, OC-beliefs, OC-related interpretation and attention biases
Read the detailed description
Cognitive behavioral therapy, consisting of exposure and response prevention and cognitive restructuring, is still one of the most effective treatments for obsessive compulsive disorder. However, some patients do not fully benefit from the treatment. This condition results in more search for novel approaches that can contribute to effectiveness of standard treatments. In this regard, the use of technology-based methods in recent researches is noteworthy. Cognitive bias modification (CBM) is one of these current efforts of technology-based methods. CBM involves computerized tasks designed to modify some cognitive biases such as attention and interpretation associated with psychopathology, particularly anxiety disorders. Researches have generally demonstrated that cognitive bias modification can be effective way to alter cognitive biases and to reduce anxiety symptoms. In recent years, there have been also some studies to investigate the potential effects of cognitive bias modification for obsessive compulsive disorder.The results of both CBM-Interpretation (CBM-I) and CBM-Attention (CBM-A) studies have shown that it is an effective and promising method in reducing cognitive biases in obsessive compulsive disorder (OCD). Although these studies are highly informative, they do not provide information about the causal role one bias has during the operation of another. In recent years, there has been a growing consensus that both biases arise from the same system, thereby, it is possible that modifying the system to alter one bias (e.g., attention), will also impact on the presence of the other bias.). In line with this notion, there are a couple of studies to test the effect of Combined Cognitive Bias Modification (CBM-C) which is combination of both CBM-A and CBM-I in intervention programs. The results of these studies are generally very positive. Although it is well established that attention bias and interpretation bias each have a key role in the development and maintenance of OCD, only one bias is targeted in CBM studies of OCD. Considering that a "combined cognitive bias" may contribute to the maintenance of several disorders, in order to try to maximise the potential clinical impact, the present research aims at exploring whether the combination of the CBM-A and CBM-I procedures would be more effective in reducing cognitive biases and OC symptoms than either alone. It is expected that internet-delivered CBM-C (iCBM-C) will result in superior treatment outcomes as indexed by internet-delivered CBM-I intervention only (iCBM-I), internet-delivered CBM-A intervention only (iCBM-A), and wait-list control (WLC).
- Conditions
- Obsessive-compulsive Disorders and Symptoms, Obsessive Thoughts, Obsessive Compulsive Behavior
- Being tested
- Internet-delivered Combined Cognitive Bias Modification (iCBM-C), Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I), Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)
- Medical subject headings
- Obsessive-Compulsive Disorder, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Combined Cognitive Bias Modification (iCBM-C)Behavioural
The iCBM-C is online CBM intervention which is the combination of iCBM-I and iCBM-A interventions for obsessive-compulsive symptoms delivered in eight sessions, twice per week for 4 weeks. The presentation order of the two intervention components will be counterbalanced to allow exploration of any order effects. Thereby, half of the participants in iCBM-C group will complete the iCBM-A task followed by iCBM-I, while the other half will complete the iCBM-I task followed by iCBM-A during each session.
Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)Behavioural
The iCBM-I is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of OCD related scenarios taking place over eight sessions, twice per week for 4 weeks.
Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)Behavioural
The iCBM-A is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of the modified dot-probe task taking place over eight sessions, twice per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered Combined Cognitive Bias Modification | Experimental | CBM Version 1 is the combination of internet-delivered Cognitive Bias Modification-Interpretation and internet-delivered Cognitive Bias Modification-Attention interventions taking place over 4 weeks (eight sessions, twice per week). Receives: Behavioral: Internet-delivered Combined Cognitive Bias Modification (iCBM-C) |
| Internet-delivered Cognitive Bias Modification-Interpretation | Experimental | CBM Version 2 is an internet-delivered Cognitive Bias Modification-Interpretation intervention taking place over 4 weeks (eight sessions, twice per week). Receives: Behavioral: Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I) |
| Internet-delivered Cognitive Bias Modification-Attention | Experimental | CBM Version 3 is an internet-delivered Cognitive Bias Modification-Attention intervention taking place over 4 weeks (eight sessions, twice per week). Receives: Behavioral: Internet-delivered Cognitive Bias Modification-Attention (iCBM-A) |
| Wait-List Control | No intervention | This arm is wait-list control group which will also receive internet-delivered Combined Cognitive Bias Modification intervention after the follow-up assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Padua Inventory-Washington State University Revision
Self-report questionnaire of obsessive compulsive symptoms composed of 39 items on a 5-point scale. Total score ranges from 0 to 156. Higher scores indicate greater severity of obsessive-compulsive symptoms (worse outcome).
Measured: Screen, Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Change in Obsessive Beliefs Questionnaire-44
Self-report questionnaire of maladaptive obsessive-compulsive beliefs composed of 44 items on a 7-point scale. Total score ranges from 44 to 308. Higher score indicates that the individual has more maladaptive obsessive-compulsive beliefs (worse outcome).
Measured: Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Change in OC bias index
Measure of interpretation biases. It is a computerized task that requires participants to read and imagine themselves in 10 OC-relevant test scenarios and 10 non OC-relevant scenarios with a title and missing letter in the final word of the sentence. Participants are then provided with a recognition rating form where they see the title of only the 10 OC-relevant scenarios in which they had previously imagined themselves. Each title corresponds with four different interpretations; target bias (OC-Positive and OC-Negative), and foil bias (Foil Positive and Foil Negative). Participants are asked to rate (on a 4-point scale) each sentence independently in terms of how similar each interpretation option is to the meaning of the scenario they had previously read. Target and Foil Bias Index scores are calculated by subtracting ratings for negative items from ratings for positive items. A positive score indicates that the individual has more OC-positive interpretations (better outcome).
Measured: Baseline (pre-intervention), post-intervention at week 4
Change in dot-probe task
Measure of attention biases. Participants are presented 48 trials comprising all combinations of probe type ("←" or "→"), probe position (top or bottom), and picture type (neutral or threat). Each trial begins with the presentation of a central fixation cross for 500 ms. The cross is then replaced by a picture pair presented in the center of the screen for 500ms. After 500 ms, both stimuli disappear and a probe is shown in the location of one of the stimuli. Participants are instructed to indicate as quickly as possible which probe was shown via using keyboardResponse latencies are averaged to provide a single mean reaction time score for each participant. Scores are calculated by subtracting response latencies for trials in which the probe replaces threat stimuli from response latencies for trials in which the probe replaces neutral stimuli. subtracting the average. A negative bias score indicates an attention bias away from threat-related pictures (better outcome).
Measured: Baseline (pre-intervention), post-intervention at week 4
Secondary outcomes (2)
Change in Depression Anxiety Stress Scale-21
Self-report questionnaire of the negative emotional states of depression, anxiety and stress composed of 21 questions on a 4-point scale. There are three subscales; (1) depression, (2) anxiety, and (3) stress. There are seven items in each of the subscales; the score of which ranges from 0 to 21. Higher scores indicate greater depression, anxiety anda stress (worse outcome).
Measured: Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Change in Positive and Negative Affect Schedule
Self-report questionnaire of positive and negative affect composed of 20 items with 10 positive and 10 negative affective descriptors on a 5-point scale. The positive and negative affect scales each have a potential range of 10-50. Higher scores on positive affect scale indicate higher positive affect (better outcome) whereas Higher scores on negative affect scale indicate higher negative affect (worse outcome).
Measured: Baseline (pre-intervention), post-intervention at week 4, 1-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 posted5 Oct 2020
- Study start15 Sep 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive Disorders and SymptomsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factor 1: Cognitive Bias Modification-Interpretation (yes or no) Factor 2: Cognitive Bias Modification-Attention (yes or no) Each participant will be randomized to one of four conditions: Condition 1: Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention Condition 2: Cognitive Bias Modification-Interpretation and No Cognitive Bias Modification-Attention Condition 3: No Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention Condition 4: No Cognitive Bias Modification-Interpretation and No Attention Bias Modification-Attention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sıla Derin, MA, Dokuz Eylul University
- Investigators
- Sıla Derin, MA, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575805
- Sponsor's protocol ID
- 120K044
- Status last verified
- Aug 2023
- First submitted
- 26 Sep 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Combined Cognitive Bias Modification (iCBM-C) in People With High Obsessive Compulsive Symptoms: A Factorial Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04575805
- Acronym / sponsor ID
- 120K044
- Conditions
- Obsessive-compulsive Disorders and Symptoms, Obsessive Thoughts, Obsessive Compulsive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 5 Oct 2020 (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.
A factorial randomised controlled trial comparing internet-delivered combined cognitive bias modification intervention (iCBM-C) versus internet-delivered CBM-interpretation intervention (iCBM-I), internet-delivered CBM-attention intervention (iCBM-A) and wait-list control on obsessive-compulsive (OC) symptoms, OC-beliefs, OC-related interpretation and attention biases
Detailed description
Cognitive behavioral therapy, consisting of exposure and response prevention and cognitive restructuring, is still one of the most effective treatments for obsessive compulsive disorder. However, some patients do not fully benefit from the treatment. This condition results in more search for novel approaches that can contribute to effectiveness of standard treatments. In this regard, the use of technology-based methods in recent researches is noteworthy. Cognitive bias modification (CBM) is one of these current efforts of technology-based methods. CBM involves computerized tasks designed to modify some cognitive biases such as attention and interpretation associated with psychopathology, particularly anxiety disorders. Researches have generally demonstrated that cognitive bias modification can be effective way to alter cognitive biases and to reduce anxiety symptoms. In recent years, there have been also some studies to investigate the potential effects of cognitive bias modification for obsessive compulsive disorder.The results of both CBM-Interpretation (CBM-I) and CBM-Attention (CBM-A) studies have shown that it is an effective and promising method in reducing cognitive biases in obsessive compulsive disorder (OCD). Although these studies are highly informative, they do not provide information about the causal role one bias has during the operation of another. In recent years, there has been a growing consensus that both biases arise from the same system, thereby, it is possible that modifying the system to alter one bias (e.g., attention), will also impact on the presence of the other bias.). In line with this notion, there are a couple of studies to test the effect of Combined Cognitive Bias Modification (CBM-C) which is combination of both CBM-A and CBM-I in intervention programs. The results of these studies are generally very positive. Although it is well established that attention bias and interpretation bias each have a key role in the development and maintenance of OCD, only one bias is targeted in CBM studies of OCD. Considering that a "combined cognitive bias" may contribute to the maintenance of several disorders, in order to try to maximise the potential clinical impact, the present research aims at exploring whether the combination of the CBM-A and CBM-I procedures would be more effective in reducing cognitive biases and OC symptoms than either alone. It is expected that internet-delivered CBM-C (iCBM-C) will result in superior treatment outcomes as indexed by internet-delivered CBM-I intervention only (iCBM-I), internet-delivered CBM-A intervention only (iCBM-A), and wait-list control (WLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Factor 1: Cognitive Bias Modification-Interpretation (yes or no) Factor 2: Cognitive Bias Modification-Attention (yes or no) Each participant will be randomized to one of four conditions: Condition 1: Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention Condition 2: Cognitive Bias Modification-Interpretation and No Cognitive Bias Modification-Attention Condition 3: No Cognitive Bias Modification-Interpretation and Cognitive Bias Modification-Attention Condition 4: No Cognitive Bias Modification-Interpretation and No Attention Bias Modification-Attention
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered Combined Cognitive Bias Modification | Experimental | Behavioral: Internet-delivered Combined Cognitive Bias Modification (iCBM-C)CBM Version 1 is the combination of internet-delivered Cognitive Bias Modification-Interpretation and internet-delivered Cognitive Bias Modification-Attention interventions taking place over 4 weeks (eight sessions, twice per week). |
| Internet-delivered Cognitive Bias Modification-Interpretation | Experimental | Behavioral: Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)CBM Version 2 is an internet-delivered Cognitive Bias Modification-Interpretation intervention taking place over 4 weeks (eight sessions, twice per week). |
| Internet-delivered Cognitive Bias Modification-Attention | Experimental | Behavioral: Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)CBM Version 3 is an internet-delivered Cognitive Bias Modification-Attention intervention taking place over 4 weeks (eight sessions, twice per week). |
| Wait-List Control | No intervention | –This arm is wait-list control group which will also receive internet-delivered Combined Cognitive Bias Modification intervention after the follow-up assessment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fluent in written and spoken Turkish
- Daily access to the internet by computer
- No participation on any other interventional study or clinical trial
- The presence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores > 65.81).
Key exclusion criteria (7 listed)
- The absence of high obsessive compulsive symptoms (Turkish version of Padua Inventory-Washington State University Revision scores < 65.81)
- Suicidal ideation and severe psychotic symptoms (a rating of slight (i.e., 1) or greater on any item within the domain based on their responses to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version
- No access to the internet and computer
- Color blindness
- A current diagnosis of neurological and psychiatric disorder
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 |
|---|---|---|
| Internet-delivered Combined Cognitive Bias Modification (iCBM-C)The iCBM-C is online CBM intervention which is the combination of iCBM-I and iCBM-A interventions for obsessive-compulsive symptoms delivered in eight sessions, twice per week for 4 weeks. The presentation order of the two intervention components will be counterbalanced to allow exploration of any order effects. Thereby, half of the participants in iCBM-C group will complete the iCBM-A task followed by iCBM-I, while the other half will complete the iCBM-I task followed by iCBM-A during each session. | Behavioural | Internet-delivered Combined Cognitive Bias Modification |
| Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)The iCBM-I is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of OCD related scenarios taking place over eight sessions, twice per week for 4 weeks. | Behavioural | Internet-delivered Cognitive Bias Modification-Interpretation |
| Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)The iCBM-A is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of the modified dot-probe task taking place over eight sessions, twice per week for 4 weeks. | Behavioural | Internet-delivered Cognitive Bias Modification-Attention |
Primary outcome
Change in Padua Inventory-Washington State University Revision
Time frame: Screen, Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Self-report questionnaire of obsessive compulsive symptoms composed of 39 items on a 5-point scale. Total score ranges from 0 to 156. Higher scores indicate greater severity of obsessive-compulsive symptoms (worse outcome).
Change in Obsessive Beliefs Questionnaire-44
Time frame: Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Self-report questionnaire of maladaptive obsessive-compulsive beliefs composed of 44 items on a 7-point scale. Total score ranges from 44 to 308. Higher score indicates that the individual has more maladaptive obsessive-compulsive beliefs (worse outcome).
Change in OC bias index
Time frame: Baseline (pre-intervention), post-intervention at week 4
Measure of interpretation biases. It is a computerized task that requires participants to read and imagine themselves in 10 OC-relevant test scenarios and 10 non OC-relevant scenarios with a title and missing letter in the final word of the sentence. Participants are then provided with a recognition rating form where they see the title of only the 10 OC-relevant scenarios in which they had previously imagined themselves. Each title corresponds with four different interpretations; target bias (OC-Positive and OC-Negative), and foil bias (Foil Positive and Foil Negative). Participants are asked to rate (on a 4-point scale) each sentence independently in terms of how similar each interpretation option is to the meaning of the scenario they had previously read. Target and Foil Bias Index scores are calculated by subtracting ratings for negative items from ratings for positive items. A positive score indicates that the individual has more OC-positive interpretations (better outcome).
Change in dot-probe task
Time frame: Baseline (pre-intervention), post-intervention at week 4
Measure of attention biases. Participants are presented 48 trials comprising all combinations of probe type ("←" or "→"), probe position (top or bottom), and picture type (neutral or threat). Each trial begins with the presentation of a central fixation cross for 500 ms. The cross is then replaced by a picture pair presented in the center of the screen for 500ms. After 500 ms, both stimuli disappear and a probe is shown in the location of one of the stimuli. Participants are instructed to indicate as quickly as possible which probe was shown via using keyboardResponse latencies are averaged to provide a single mean reaction time score for each participant. Scores are calculated by subtracting response latencies for trials in which the probe replaces threat stimuli from response latencies for trials in which the probe replaces neutral stimuli. subtracting the average. A negative bias score indicates an attention bias away from threat-related pictures (better outcome).
2 secondary outcomes
Change in Depression Anxiety Stress Scale-21
Time frame: Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up
Change in Positive and Negative Affect Schedule
Time frame: Baseline (pre-intervention), post-intervention at week 4, 1-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 14 Aug 2023.
- 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.
Sıla Derin, MA study chair
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Combined Cognitive Bias Modification (iCBM-C), Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I) and Internet-delivered Cognitive Bias Modification-Attention (iCBM-A) in people with Obsessive-compulsive Disorders and Symptoms and Obsessive Thoughts, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 7 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 14 Aug 2023. 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 Turkey (Türkiye). 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?
Change in Padua Inventory-Washington State University Revision (time frame: Screen, Baseline (pre-intervention), post-intervention at week 4, 1-month follow-up). The study lists 4 primary outcomes in all. 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 14 Aug 2023.