Bipolar DisorderNCT05693389
Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders
A study testing acceptance and commitment therapy and routine hospital care in people with Bipolar Disorder, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- acceptance and commitment therapy and routine hospital care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders: A Randomized Controlled Trial
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.
- Conditions
- Bipolar Disorder
- Being tested
- acceptance and commitment therapy, routine hospital care
- Keywords
- Acceptance and commitment therapy, Bipolar disorders, Impulsivity, Suicidality
- Medical subject headings
- Bipolar Disorder, Impulsive Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptance and commitment therapyBehavioural
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.
routine hospital careOther
the patients with bipolar disorders who receive routine pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start15 Sep 2022
- Primary completion15 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayman el-ashry, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693389
- Sponsor's protocol ID
- IRB00013620/64/9/2022
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27530736Shahed, 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.
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.
PubMed 27647353Bteich 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.
PubMed 28683772Beck 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.
PubMed 3170753El-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.
PubMed 37592290
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05693389
- Acronym / sponsor ID
- IRB00013620/64/9/2022
- Conditions
- Bipolar Disorder
- Keywords
- Acceptance and commitment therapy, Bipolar disorders, Impulsivity, Suicidality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with bipolar disorder who will partaicpmg in acceptance and commitment therapy | Active comparator | Behavioral: acceptance and commitment therapypatients with bipolar disorder who will participate in acceptance and commitment therapy |
| patients with bipolar disorder who will be under routine hospital care | Placebo comparator | Other: routine hospital carepatients with bipolar disorder who will be under routine hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acceptance and commitment therapyACT 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. | Behavioural | patients with bipolar disorder who will partaicpmg in acceptance and commitment therapy |
| routine hospital carethe patients with bipolar disorders who receive routine pharmacological treatment | Other | patients with bipolar disorder who will be under routine hospital care |
Primary outcome
Impulsivity
Time frame: up to 16 weeks
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
Time frame: up to 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Background: PubMed 27530736Strasser 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.
- BackgroundShahed, 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: PubMed 27647353Pankowski 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.
- Background: PubMed 28683772Bteich 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.
- Background: PubMed 3170753Beck 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.
- Derived from this study: PubMed 37592290El-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acceptance and commitment therapy and routine hospital care in people with Bipolar Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impulsivity (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693389, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.