- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05759091
Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Alexandria, Egypt, 002
- Faculty of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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
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No Intervention: control group
patients with schizophrenia who suffer from persistent delusions participated in usual routine care in the hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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up to 14 weeks
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The Cognitive Fusion Questionnaire-7 (CFQ-7)
Time Frame: up to 14 weeks
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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.
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up to 14 weeks
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Southampton Mindfulness Questionnaire (SMQ)
Time Frame: up to 14 weeks
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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.
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up to 14 weeks
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Psychotic Symptom Rating Scales (PSYRATS-D)
Time Frame: up to 14 weeks
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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).
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up to 14 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayman Mohamed El-Ashry, PHD, Faculty of nursing, Alexandria university, Egypt
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00013620/63/9/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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