NCT05759091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

February 25, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

Believability of DelusionsCognitive Defusion techniquesCognitive FusionMindful AwarenessSchizophrenia

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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).

    up to 14 weeks

Study Arms (2)

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.

Behavioral: cognitive defusion techniques

control group

NO INTERVENTION

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

Interventions

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

cognitive defusion interventional group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male patients with schizophrenia included in this study to decrease confounding factors.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any client in an acute phase or have any neurological disorder that may affect cognitive function were excluded from a study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 002, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 12362963BACKGROUND
  • 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.

    PMID: 27993338BACKGROUND
  • 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.

    PMID: 35982935BACKGROUND
  • El-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.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDelusions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ayman Mohamed El-Ashry, PHD

    Faculty of nursing, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of psychiatric nursing and mental health department

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 8, 2023

Study Start

September 10, 2022

Primary Completion

November 20, 2022

Study Completion

January 20, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations