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

Primary Purpose

Schizophrenia; Psychosis, Nurse's Role, Delusions

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cognitive defusion techniques
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia; Psychosis focused on measuring Believability of Delusions, Cognitive Defusion techniques, Cognitive Fusion, Mindful Awareness, Schizophrenia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cognitive defusion interventional group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
February 25, 2023
Last Updated
July 18, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05759091
Brief Title
Effect of Applying Cognitive Defusion Techniques on Mindful Awareness, Cognitive Fusion and Believability of Delusions Among Clients With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis, Nurse's Role, Delusions
Keywords
Believability of Delusions, Cognitive Defusion techniques, Cognitive Fusion, Mindful Awareness, Schizophrenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive defusion interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients with schizophrenia who suffer from persistent delusions participated in usual routine care in the hospital.
Intervention Type
Behavioral
Intervention Name(s)
cognitive defusion techniques
Intervention Description
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
Primary Outcome Measure Information:
Title
The Acceptance and Action Questionnaire-II (AAQII)
Description
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
Title
The Cognitive Fusion Questionnaire-7 (CFQ-7)
Description
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
Title
Southampton Mindfulness Questionnaire (SMQ)
Description
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
Title
Psychotic Symptom Rating Scales (PSYRATS-D)
Description
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

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male patients with schizophrenia included in this study to decrease confounding factors.
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Mohamed El-Ashry, PHD
Organizational Affiliation
Faculty of nursing, Alexandria University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12362963
Citation
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.
Results Reference
background
PubMed Identifier
27993338
Citation
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.
Results Reference
background
PubMed Identifier
35982935
Citation
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.
Results Reference
background

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

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