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Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
acceptance and commitment therapy
routine hospital care
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder focused on measuring Acceptance and commitment therapy, Bipolar disorders, Impulsivity, Suicidality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clients had to be at least 18 years old able to converse intelligibly and meaningfully read and write have an illness that hadn't lasted more than 10 years to assure the client's functionality ready to take part in the study. Exclusion Criteria: Clients who demonstrated psychotic symptoms attended another group sessions were intoxicated or under the influence of alcohol had any comorbidity were excluded from this study

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

patients with bipolar disorder who will partaicpmg in acceptance and commitment therapy

patients with bipolar disorder who will be under routine hospital care

Arm Description

patients with bipolar disorder who will participate in acceptance and commitment therapy

patients with bipolar disorder who will be under routine hospital care

Outcomes

Primary Outcome Measures

Impulsivity
This questionnaire has 20 items that assess five aspects of impulsivity: positive eagerness, negative urgency, lack of perseverance, lack of premeditation, and sensation seeking. Each of the five aspects is evaluated using four items on a four-point Likert scales with anchors 1 (=Strongly agree) and 4 (=Strongly disagree). An elevated prevalence of impulsivity is reflected in higher scores.To create the Arabic S-UPPS-P, investigators had a professional translator translate the original S-UPPS-P's items from English into Arabic, and then back-translated into Arabic.
Suicide Ideation
BSSI is a 19-item scale that assesses the presence and intensity of suicidal thoughts in the week before examination. Each item is rated on an ordinal scale of 0 to 2, and the total score ranges from 0 to 38. Individuals respond to the first five things that are excerpted. If an individual replies positively to the fifth item (scores 1 and 2), he or she answers the remaining items; otherwise, the questionnaire is finished. There was no cut-off point utilised to classify the scores. As a result, for data analysis, investigators used overall scale scores.The more score increased, the more the client vulnerable to suicide.

Secondary Outcome Measures

Full Information

First Posted
December 25, 2022
Last Updated
January 11, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05693389
Brief Title
Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders
Official Title
The Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 20, 2022 (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
Psychiatric nurses face a huge challenge in predicting and preventing suicide behaviour in their patients with bipolar disorders, but it may also be one of the most accurate measures of how well their clinical care is working. In addition to, high impulsivity scores are associated with increased overall functional impairment, a higher number of episodes with early onset, and a higher number of past suicide attempts, as well as increased substance intake. Thus, this study aimed at evaluating the efficacy acceptance and commitment therapy on impulsivity and suicidality among bipolar clients. research hypnosis Clients who engaged in acceptance and commitment therapy had less impulsivity than the control group. Clients who engaged in acceptance and commitment therapy had less suicidality than the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Acceptance and commitment therapy, Bipolar disorders, Impulsivity, Suicidality

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
patients with bipolar disorder who will partaicpmg in acceptance and commitment therapy
Arm Type
Active Comparator
Arm Description
patients with bipolar disorder who will participate in acceptance and commitment therapy
Arm Title
patients with bipolar disorder who will be under routine hospital care
Arm Type
Placebo Comparator
Arm Description
patients with bipolar disorder who will be under routine hospital care
Intervention Type
Behavioral
Intervention Name(s)
acceptance and commitment therapy
Intervention Description
ACT attempts to encourage psychological flexibility, acceptance of one's own experiences, and dedication to behaviours that are consistent with one's own values. ACT therapies focus on six key processes to improve psychological flexibility: engagement with the present moment, acceptance, defusion, self as context, values clarification, and committed action.
Intervention Type
Other
Intervention Name(s)
routine hospital care
Intervention Description
the patients with bipolar disorders who receive routine pharmacological treatment
Primary Outcome Measure Information:
Title
Impulsivity
Description
This questionnaire has 20 items that assess five aspects of impulsivity: positive eagerness, negative urgency, lack of perseverance, lack of premeditation, and sensation seeking. Each of the five aspects is evaluated using four items on a four-point Likert scales with anchors 1 (=Strongly agree) and 4 (=Strongly disagree). An elevated prevalence of impulsivity is reflected in higher scores.To create the Arabic S-UPPS-P, investigators had a professional translator translate the original S-UPPS-P's items from English into Arabic, and then back-translated into Arabic.
Time Frame
up to 16 weeks
Title
Suicide Ideation
Description
BSSI is a 19-item scale that assesses the presence and intensity of suicidal thoughts in the week before examination. Each item is rated on an ordinal scale of 0 to 2, and the total score ranges from 0 to 38. Individuals respond to the first five things that are excerpted. If an individual replies positively to the fifth item (scores 1 and 2), he or she answers the remaining items; otherwise, the questionnaire is finished. There was no cut-off point utilised to classify the scores. As a result, for data analysis, investigators used overall scale scores.The more score increased, the more the client vulnerable to suicide.
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clients had to be at least 18 years old able to converse intelligibly and meaningfully read and write have an illness that hadn't lasted more than 10 years to assure the client's functionality ready to take part in the study. Exclusion Criteria: Clients who demonstrated psychotic symptoms attended another group sessions were intoxicated or under the influence of alcohol had any comorbidity were excluded from this study
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
27530736
Citation
Strasser ES, Haffner P, Fiebig J, Quinlivan E, Adli M, Stamm TJ. Behavioral measures and self-report of impulsivity in bipolar disorder: no association between Stroop test and Barratt Impulsiveness Scale. Int J Bipolar Disord. 2016 Dec;4(1):16. doi: 10.1186/s40345-016-0057-1. Epub 2016 Aug 17.
Results Reference
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Citation
Shahed, H., Ghadam, H., Taghva, A., Ebrahimi, M. R., Donyavi, V., & Ghasemzadeh, M. R. (2020). Effectiveness of Acceptance and Commitment Therapy in Reducing Symptoms of Anxiety , Depression , and Suicidal Ideation in Iranian Veterans Referred to a Military Psychiatric Hospital.
Results Reference
background
PubMed Identifier
27647353
Citation
Pankowski S, Adler M, Andersson G, Lindefors N, Svanborg C. Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety - an open pilot study. Cogn Behav Ther. 2017 Mar;46(2):114-128. doi: 10.1080/16506073.2016.1231218. Epub 2016 Sep 19.
Results Reference
background
PubMed Identifier
28683772
Citation
Bteich G, Berbiche D, Khazaal Y. Validation of the short Arabic UPPS-P Impulsive Behavior Scale. BMC Psychiatry. 2017 Jul 6;17(1):244. doi: 10.1186/s12888-017-1407-y.
Results Reference
background
PubMed Identifier
3170753
Citation
Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
Results Reference
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Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders

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