Dialectical Behavior TherapyNCT05741268
Effect of Dialectical Behavior in Patients With Bipolar Disorder
A study testing Dialectical behavior therapy in people with Dialectical Behavior Therapy, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to: Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation difficulties, distress tolerance, and social functioning among patients with bipolar disorder. Read more about this study
- Who is it for?
- Ages 50 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dialectical Behavior Therapy
- What is being tested?
- Dialectical behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 10 Sep 2023
- 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 50 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:1. Diagnosed with bipolar disorder for at least one month according to DSM V with no co-morbidity.
- Their age does not exceed 60 years old. 3. Able to read and write. 4. Able \& willing to participate in the study. 5. Living in Alexandria Governorate, Egypt.
Exclusion Criteria: demonstrate severe psychopathological symptom ( i.e: patient in acute stage)
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dialectical Behavior Therapy on Emotion Regulation Difficulties, Distress Tolerance, and Social Functioning Among Patients With Bipolar Disorder: A Randomized Controlled Trial
This study aims to:
- Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation difficulties, distress tolerance, and social functioning among patients with bipolar disorder.
RESEARCH HYPOTHESIS Patients with bipolar disorder who are exposed to Dialectical Behavior Therapy will exhibit lower emotion regulation difficulties, distress tolerance, and higher social functioning than those who are not exposed to such training.
Read the detailed description
The researchers decided to work on a convenient sample of 30 adult patients with bipolar disorder. Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation.
- Conditions
- Dialectical Behavior Therapy
- Being tested
- Dialectical behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapyBehavioural
- Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in the following sequence 1. Mindfulness , 2. Emotion Regulation , 3. Distress Tolerance and 4. Interpersonal effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical behavior therapy | Experimental | Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation. Receives: Behavioral: Dialectical behavior therapy |
| Routine psychological care | Active comparator | they will receive psychological care such as stress management and social skills training. Receives: Behavioral: Dialectical behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotional Regulation Scale (DERS)
This tool (DERS) is a 36-items self-report scale developed by Gratz and Roemer (2004) to assess emotion regulation difficulties. The scale items are classified into six general subscales; non- acceptance of emotional responses (6 items); difficulty engaging in goal-directed behaviors (5 items); impulse control difficulties (6 items); lack of emotional awareness (6 items); limited access to emotional regulation strategies (8 items), and lack of emotional clarity (5 items).
Measured: 2 weeks
Secondary outcomes (1)
Distress Tolerance Scale (DTS)
The DTS (Simons \& Gaher, 2005) is a 15-item selfreport questionnaire that assesses tolerance of distress, appraisal of distress, attention absorbed by negative emotions, and regulation efforts to alleviate distress. Items are rated on a 1 to 5 scale (1 = strongly agree; 5 = strongly disagree) with lower scores indicating poorer tolerance of distress. The DTS scale has demonstrated good test-retest reliability. In the current study the internal consistency of the DTS was excellent (Cronbach's α = .92).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start2 Mar 2023
- Primary completion15 Jul 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dialectical Behavior TherapyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
- Investigators
- Eman Taha, Study chair, Egypt Faculty of Nursing Alexandria, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741268
- Sponsor's protocol ID
- 15122022
- Status last verified
- Jul 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Musket CW, Hansen NS, Welker KM, Gilbert KE, Gruber J. A pilot investigation of emotional regulation difficulties and mindfulness-based strategies in manic and remitted bipolar I disorder and major depressive disorder. Int J Bipolar Disord. 2021 Jan 4;9(1):2. doi: 10.1186/s40345-020-00206-0.
PubMed 33392824Miola A, Cattarinussi G, Antiga G, Caiolo S, Solmi M, Sambataro F. Difficulties in emotion regulation in bipolar disorder: A systematic review and meta-analysis. J Affect Disord. 2022 Apr 1;302:352-360. doi: 10.1016/j.jad.2022.01.102. Epub 2022 Jan 29.
PubMed 35093412Dodd AL, Gilbert K, Gruber J. Beliefs about the automaticity of positive mood regulation: examination of the BAMR-Positive Emotion Downregulation Scale in relation to emotion regulation strategies and mood symptoms. Cogn Emot. 2020 Mar;34(2):384-392. doi: 10.1080/02699931.2019.1626700. Epub 2019 Jun 7.
PubMed 31174453Eisner L, Eddie D, Harley R, Jacobo M, Nierenberg AA, Deckersbach T. Dialectical Behavior Therapy Group Skills Training for Bipolar Disorder. Behav Ther. 2017 Jul;48(4):557-566. doi: 10.1016/j.beth.2016.12.006. Epub 2017 Jan 6.
PubMed 28577590
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dialectical Behavior Therapy on Emotion Regulation Difficulties, Distress Tolerance, and Social Functioning Among Patients With Bipolar Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05741268
- Acronym / sponsor ID
- 15122022
- Conditions
- Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 23 Feb 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.
This study aims to:
- Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation difficulties, distress tolerance, and social functioning among patients with bipolar disorder.
RESEARCH HYPOTHESIS Patients with bipolar disorder who are exposed to Dialectical Behavior Therapy will exhibit lower emotion regulation difficulties, distress tolerance, and higher social functioning than those who are not exposed to such training.
Detailed description
The researchers decided to work on a convenient sample of 30 adult patients with bipolar disorder. Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical behavior therapy | Experimental | Behavioral: Dialectical behavior therapyDialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation. |
| Routine psychological care | Active comparator | Behavioral: Dialectical behavior therapythey will receive psychological care such as stress management and social skills training. |
Who may qualify
- Ages
- 50 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Dialectical behavior therapy14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in the following sequence 1. Mindfulness , 2. Emotion Regulation , 3. Distress Tolerance and 4. Interpersonal effectiveness. | Behavioural | Dialectical behavior therapy, Routine psychological care |
Primary outcome
Difficulties in Emotional Regulation Scale (DERS)
Time frame: 2 weeks
This tool (DERS) is a 36-items self-report scale developed by Gratz and Roemer (2004) to assess emotion regulation difficulties. The scale items are classified into six general subscales; non- acceptance of emotional responses (6 items); difficulty engaging in goal-directed behaviors (5 items); impulse control difficulties (6 items); lack of emotional awareness (6 items); limited access to emotional regulation strategies (8 items), and lack of emotional clarity (5 items).
1 secondary outcome
Distress Tolerance Scale (DTS)
Time frame: 2 weeks
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 Aug 2024.
- Background: PubMed 33392824Musket CW, Hansen NS, Welker KM, Gilbert KE, Gruber J. A pilot investigation of emotional regulation difficulties and mindfulness-based strategies in manic and remitted bipolar I disorder and major depressive disorder. Int J Bipolar Disord. 2021 Jan 4;9(1):2. doi: 10.1186/s40345-020-00206-0.
- Background: PubMed 35093412Miola A, Cattarinussi G, Antiga G, Caiolo S, Solmi M, Sambataro F. Difficulties in emotion regulation in bipolar disorder: A systematic review and meta-analysis. J Affect Disord. 2022 Apr 1;302:352-360. doi: 10.1016/j.jad.2022.01.102. Epub 2022 Jan 29.
- Background: PubMed 31174453Dodd AL, Gilbert K, Gruber J. Beliefs about the automaticity of positive mood regulation: examination of the BAMR-Positive Emotion Downregulation Scale in relation to emotion regulation strategies and mood symptoms. Cogn Emot. 2020 Mar;34(2):384-392. doi: 10.1080/02699931.2019.1626700. Epub 2019 Jun 7.
- Background: PubMed 28577590Eisner L, Eddie D, Harley R, Jacobo M, Nierenberg AA, Deckersbach T. Dialectical Behavior Therapy Group Skills Training for Bipolar Disorder. Behav Ther. 2017 Jul;48(4):557-566. doi: 10.1016/j.beth.2016.12.006. Epub 2017 Jan 6.
- 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.
Eman Taha study chair
Egypt Faculty of Nursing Alexandria, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy in people with Dialectical Behavior Therapy, 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?
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 Aug 2024. 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. 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?
Difficulties in Emotional Regulation Scale (DERS) (time frame: 2 weeks). 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 NCT05741268, which also lists 4 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 Aug 2024.