ClinicalTrials.gg
CompletedNCT05759091Updated Jul 19, 2023

Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia

An interventional study of cognitive defusion techniques in Schizophrenia; Psychosis, Nurse's Role and Delusions, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Sex
Male
01

Study 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. 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.
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Conditions studied

  • Schizophrenia; Psychosis
  • Nurse's Role
  • Delusions

Keywords

  • Believability of Delusions
  • Cognitive Defusion techniques
  • Cognitive Fusion
  • Mindful Awareness
  • Schizophrenia
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In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's enrollment of 70 is close to the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male clients diagnosed with schizophrenia according to the
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    cognitive defusion interventional group

    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.

    Behavioral: cognitive defusion techniques

  • No intervention
    control group

    patients with schizophrenia who suffer from persistent delusions participated in usual routine care in the hospital.

Interventions

  • Behavioralcognitive defusion techniques

    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 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 14 weeks

  2. 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.

    Time frame: up to 14 weeks

  3. 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.

    Time frame: up to 14 weeks

  4. 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).

    Time frame: up to 14 weeks

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Study locations

1 site
  • Faculty of Nursing
    Alexandria, 002, Egypt
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References and documents

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 12362963 ↗
  • Hayes 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 27993338 ↗
  • Boge 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 35982935 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Nov 2022, 2 months.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 2 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2023
First posted
Mar 8, 2023
StartActual
Sep 10, 2022
Primary completionActual
Nov 20, 2022
CompletionActual
Jan 20, 2023
Last update
Jul 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05759091
Responsible party
ayman el-ashry (lecturer of psychiatric nursing and mental health department, Alexandria University) — Principal investigator
First posted
Mar 8, 2023
Start date
Sep 10, 2022
Primary completion
Nov 20, 2022
Completion
Jan 20, 2023
Last update
Jul 19, 2023

Study contacts

Ayman Mohamed El-Ashry, PHD
principal investigator · Faculty of nursing, Alexandria University, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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