NCT05693389

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

December 25, 2022

Last Update Submit

January 11, 2023

Conditions

Bipolar Disorder

Keywords

Acceptance and commitment therapyBipolar disordersImpulsivitySuicidality

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 16 weeks

  • 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.

    up to 16 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

Behavioral: acceptance and commitment therapy

patients with bipolar disorder who will be under routine hospital care

PLACEBO COMPARATOR

patients with bipolar disorder who will be under routine hospital care

Other: routine hospital care

Interventions

acceptance and commitment therapyBEHAVIORAL

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.

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

the patients with bipolar disorders who receive routine pharmacological treatment

patients with bipolar disorder who will be under routine hospital care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 002, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 27530736BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27647353BACKGROUND

  • 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.

    PMID: 28683772BACKGROUND

  • 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.

    PMID: 3170753BACKGROUND

  • El-Sayed MM, Elhay ESA, Taha SM, Khedr MA, Mansour FSA, El-Ashry AM. Efficacy of acceptance and commitment therapy on impulsivity and suicidality among clients with bipolar disorders: a randomized control trial. BMC Nurs. 2023 Aug 17;22(1):271. doi: 10.1186/s12912-023-01443-1.

    PMID: 37592290DERIVED

MeSH Terms

Conditions

Bipolar DisorderImpulsive BehaviorSuicidal Ideation

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehaviorSuicideSelf-Injurious BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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 at psychiatric nursing and mental health

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 23, 2023

Study Start

September 15, 2022

Primary Completion

November 15, 2022

Study Completion

December 20, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)