Schizophrenia; PsychosisNCT05759091
Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia
A study testing cognitive defusion techniques in people with Schizophrenia; Psychosis and Nurse's Role, run by Alexandria University at 1 site in Egypt.
Trial summary
Schizophrenia causes hallucinations, delusions, and disorganized thinking, resulting in decreased functioning and lifelong therapy.Delusion believability is the degree of belief in the truth of one's subjective experiences as representations of reality. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Schizophrenia; Psychosis, Nurse's Role, Delusions
- What is being tested?
- cognitive defusion techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2022to 20 Jan 2023
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male clients diagnosed with schizophrenia according to the DSM-V
- Diagnosed with schizophrenia With no comorbidity.
- Able to communicate coherently and relevantly.
- Able to read and write.
- Willing to participate in the study
- Duration of illness not exceeding 10 years.
Who cannot join
- Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia: A Randomized Control Trial
Schizophrenia causes hallucinations, delusions, and disorganized thinking, resulting in decreased functioning and lifelong therapy.Delusion believability is the degree of belief in the truth of one's subjective experiences as representations of reality. It was unpleasant, typically accompanied by a suspicious, strange tension. Delusional belief is seen as a means of resolving tension and conflict in cognition and experience. Previous studies have shown that cognitive defusion strategies help people become more aware of their surroundings, accept their thoughts and feelings, and become more psychologically adjustable. defusion is crucial in reducing medication-resistant psychotic symptoms such delusions in schizophrenia patients. Therefore, this study aimed to investigate the effects of cognitive defusion techniques on psychological flexibility, mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia.
Research Hypothesizes
- Clients who participated in cognitive defusion techniques had more psychological flexibility and mindful awareness than the control group.
- Clients who participated in cognitive defusion techniques had less cognitive fusion and delusional believability than the control group.
- Conditions
- Schizophrenia; Psychosis, Nurse's Role, Delusions
- Being tested
- cognitive defusion techniques
- Keywords
- Believability of Delusions, Cognitive Defusion techniques, Cognitive Fusion, Mindful Awareness, Schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive defusion techniquesBehavioural
Defusing from your delusions helps to lessen their negative impact on your behaviour. So defusion is a vital step towards being able to act flexibly, in accordance with core values, instead of being dictated to by inflexible rules, reasons, judgments etc. There are numerous exercises in ACT Companion with a focus on identifying unhelpful thoughts which would benefit from defusion, or building defusion skills, most of which are found in the open up section of the app. Some of these are reading and writing exercises, and some are guided meditation audio recordings.
ACT Companion defusion exercises
- Letting go
- Not good enough
- Thought defusion
- Observing your thoughts
- Labelling thoughts and feelings
- I am having the thought that.....
- milk.milk.milk exercise
- silly voice exercise, passenger on the bus, tug of war with a monster
| Study group | Role | What they receive |
|---|---|---|
| cognitive defusion interventional group | Experimental | patients with schizophrenia who suffer from persistent delusions participated in cognitive defusion techniques on individual base through sex sessions twice weekly with homework assignments between sessions and skills demonstration by simulation and psychodrama. Receives: Behavioral: cognitive defusion techniques |
| control group | No intervention | patients with schizophrenia who suffer from persistent delusions participated in usual routine care in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Acceptance and Action Questionnaire-II (AAQII)
It is a seven-item self-reported scale developed to measure of psychological flexibility, with items targeted to several of the six key processes: defusion, acceptance, and committed action (example item: 'I worry about not being able to control my worries and feelings'.). Each item is followed by a seven-category response scale, started from never true (1), very seldom true (2), seldom true (3), sometimes true (4), frequently true (5), almost always true (6) to always true (7). Higher scores indicate greater psychological inflexibility (total score range: 7-49, calculated as the sum of the item responses). Previous research has reported a Cronbach's of 0.84.
Measured: up to 14 weeks
The Cognitive Fusion Questionnaire-7 (CFQ-7)
It is designed to elicit one's level of cognitive fusion (example item: 'I find it easy to view my thoughts from a different perspective'.). Respondents rate each of 7 items on a 7- Likert scale ranging from 1 'Never true' to 7 'Always true'. Higher scores on the CFQ indicate greater cognitive fusion (total score range: 7-49, calculated as a sum of the responses). Studies demonstrate satisfactory reliability with a Cronbach's of 0.86.
Measured: up to 14 weeks
Southampton Mindfulness Questionnaire (SMQ)
Southampton Mindfulness Questionnaire is a 16-item scale that assesses the relationship one establishes with distressing thoughts and images (e.g., "I am able just to notice them without reacting"). Items are scored on a 7-point Likert scale, ranging from strongly disagree (0) to strongly agree (6). In the original study, the Cronbach's alpha obtained was 0.89.
Measured: up to 14 weeks
Psychotic Symptom Rating Scales (PSYRATS-D)
It consists of 17 items divided into two subscales designed to rate auditory hallucinations and delusions. In this study, only the delusion subscale (PSYRATS-D) was used. The Delusion subscale measures various dimensions of delusion through 6 items divided into emotional characteristics (distress) and cognitive interpretation subscales. The first subscale is for cognitive interpretation (4 items) includes Amount of preoccupation with delusions, Duration of preoccupation with delusions, Conviction, and Disruption to life caused by beliefs. The second subscale is for emotional distress of delusions (2 items) Amount of Distress, and Intensity of Distress. The PSYRATS-AH was rated on a five-point Likert scale ranging from 0 (not endorsing the item) to 4 (fully endorsing the item). With a total score range from 0 to 24. The PSYRATS-D has been found to have high inter-rater reliability (0.99-1) and test-retest reliability (r = 0.70).
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Sep 2022
- Primary completion20 Nov 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayman el-ashry, Alexandria University
- Investigators
- Ayman Mohamed El-Ashry, PHD, Principal investigator, Faculty of nursing, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759091
- Sponsor's protocol ID
- IRB00013620/63/9/2022
- Status last verified
- Jul 2023
- First submitted
- 25 Feb 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.
PubMed 12362963Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
PubMed 27993338Boge K, Pollex F, Bergmann N, Hahne I, Zierhut MM, Mavituna S, Thomas N, Hahn E. Mindfulness, cognitive fusion, and self-compassion in patients with schizophrenia spectrum disorders-A cross-sectional study. Front Psychiatry. 2022 Aug 2;13:959467. doi: 10.3389/fpsyt.2022.959467. eCollection 2022.
PubMed 35982935El-Ashry AM, Abd Elhay ES, Taha SM, Khedr MA, Attalla Mansour FS, Alabdullah AAS, Farghaly Abdelaliem SM, El-Sayed MM. Effect of applying nursing-based cognitive defusion techniques on mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia: a randomized control trial. Front Psychiatry. 2024 Apr 26;15:1369160. doi: 10.3389/fpsyt.2024.1369160. eCollection 2024.
PubMed 38736628
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05759091
- Acronym / sponsor ID
- IRB00013620/63/9/2022
- Conditions
- Schizophrenia; Psychosis, Nurse's Role, Delusions
- Keywords
- Believability of Delusions, Cognitive Defusion techniques, Cognitive Fusion, Mindful Awareness, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Mar 2023 (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.
Schizophrenia causes hallucinations, delusions, and disorganized thinking, resulting in decreased functioning and lifelong therapy.Delusion believability is the degree of belief in the truth of one's subjective experiences as representations of reality. It was unpleasant, typically accompanied by a suspicious, strange tension. Delusional belief is seen as a means of resolving tension and conflict in cognition and experience. Previous studies have shown that cognitive defusion strategies help people become more aware of their surroundings, accept their thoughts and feelings, and become more psychologically adjustable. defusion is crucial in reducing medication-resistant psychotic symptoms such delusions in schizophrenia patients. Therefore, this study aimed to investigate the effects of cognitive defusion techniques on psychological flexibility, mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia.
Research Hypothesizes
- Clients who participated in cognitive defusion techniques had more psychological flexibility and mindful awareness than the control group.
- Clients who participated in cognitive defusion techniques had less cognitive fusion and delusional believability than the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive defusion interventional group | Experimental | Behavioral: cognitive defusion techniquespatients with schizophrenia who suffer from persistent delusions participated in cognitive defusion techniques on individual base through sex sessions twice weekly with homework assignments between sessions and skills demonstration by simulation and psychodrama. |
| control group | No intervention | –patients with schizophrenia who suffer from persistent delusions participated in usual routine care in the hospital. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male clients diagnosed with schizophrenia according to the DSM-V
- Diagnosed with schizophrenia With no comorbidity.
- Able to communicate coherently and relevantly.
- Able to read and write.
- Willing to participate in the study
Key exclusion criteria (1 listed)
- Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a 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 |
|---|---|---|
| cognitive defusion techniquesDefusing from your delusions helps to lessen their negative impact on your behaviour. So defusion is a vital step towards being able to act flexibly, in accordance with core values, instead of being dictated to by inflexible rules, reasons, judgments etc. There are numerous exercises in ACT Companion with a focus on identifying unhelpful thoughts which would benefit from defusion, or building defusion skills, most of which are found in the open up section of the app. Some of these are reading and writing exercises, and some are guided meditation audio recordings. ACT Companion defusion exercises 1. Letting go 2. Not good enough 3. Thought defusion 4. Observing your thoughts 5. Labelling thoughts and feelings 6. I am having the thought that..... 7. milk.milk.milk exercise 8. silly voice exercise, passenger on the bus, tug of war with a monster | Behavioural | cognitive defusion interventional group |
Primary outcome
The Acceptance and Action Questionnaire-II (AAQII)
Time frame: up to 14 weeks
It is a seven-item self-reported scale developed to measure of psychological flexibility, with items targeted to several of the six key processes: defusion, acceptance, and committed action (example item: 'I worry about not being able to control my worries and feelings'.). Each item is followed by a seven-category response scale, started from never true (1), very seldom true (2), seldom true (3), sometimes true (4), frequently true (5), almost always true (6) to always true (7). Higher scores indicate greater psychological inflexibility (total score range: 7-49, calculated as the sum of the item responses). Previous research has reported a Cronbach's of 0.84.
The Cognitive Fusion Questionnaire-7 (CFQ-7)
Time frame: up to 14 weeks
It is designed to elicit one's level of cognitive fusion (example item: 'I find it easy to view my thoughts from a different perspective'.). Respondents rate each of 7 items on a 7- Likert scale ranging from 1 'Never true' to 7 'Always true'. Higher scores on the CFQ indicate greater cognitive fusion (total score range: 7-49, calculated as a sum of the responses). Studies demonstrate satisfactory reliability with a Cronbach's of 0.86.
Southampton Mindfulness Questionnaire (SMQ)
Time frame: up to 14 weeks
Southampton Mindfulness Questionnaire is a 16-item scale that assesses the relationship one establishes with distressing thoughts and images (e.g., "I am able just to notice them without reacting"). Items are scored on a 7-point Likert scale, ranging from strongly disagree (0) to strongly agree (6). In the original study, the Cronbach's alpha obtained was 0.89.
Psychotic Symptom Rating Scales (PSYRATS-D)
Time frame: up to 14 weeks
It consists of 17 items divided into two subscales designed to rate auditory hallucinations and delusions. In this study, only the delusion subscale (PSYRATS-D) was used. The Delusion subscale measures various dimensions of delusion through 6 items divided into emotional characteristics (distress) and cognitive interpretation subscales. The first subscale is for cognitive interpretation (4 items) includes Amount of preoccupation with delusions, Duration of preoccupation with delusions, Conviction, and Disruption to life caused by beliefs. The second subscale is for emotional distress of delusions (2 items) Amount of Distress, and Intensity of Distress. The PSYRATS-AH was rated on a five-point Likert scale ranging from 0 (not endorsing the item) to 4 (fully endorsing the item). With a total score range from 0 to 24. The PSYRATS-D has been found to have high inter-rater reliability (0.99-1) and test-retest reliability (r = 0.70).
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 19 Jul 2023.
- Background: PubMed 12362963Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.
- Background: PubMed 27993338Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
- Background: PubMed 35982935Boge K, Pollex F, Bergmann N, Hahne I, Zierhut MM, Mavituna S, Thomas N, Hahn E. Mindfulness, cognitive fusion, and self-compassion in patients with schizophrenia spectrum disorders-A cross-sectional study. Front Psychiatry. 2022 Aug 2;13:959467. doi: 10.3389/fpsyt.2022.959467. eCollection 2022.
- Derived from this study: PubMed 38736628El-Ashry AM, Abd Elhay ES, Taha SM, Khedr MA, Attalla Mansour FS, Alabdullah AAS, Farghaly Abdelaliem SM, El-Sayed MM. Effect of applying nursing-based cognitive defusion techniques on mindful awareness, cognitive fusion, and believability of delusions among clients with schizophrenia: a randomized control trial. Front Psychiatry. 2024 Apr 26;15:1369160. doi: 10.3389/fpsyt.2024.1369160. eCollection 2024.
- 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.
Ayman Mohamed El-Ashry, PHD principal investigator
Faculty of nursing, Alexandria University, Egypt
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 defusion techniques in people with Schizophrenia; Psychosis and Nurse's Role, run by Alexandria University at 1 site 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 6 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 19 Jul 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 Egypt. 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?
The Acceptance and Action Questionnaire-II (AAQII) (time frame: up to 14 weeks). 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?
On the ClinicalTrials.gov record for NCT05759091, which also lists 4 linked publications.
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 19 Jul 2023.