Acute Stroke Patients With DepressionNCT05727358
Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
A study testing Group-based Acceptance and Commitment Therapy in people with Acute Stroke Patients With Depression, run by PLA Rocket Force Characteristic Medical Center at 1 site in China.
Trial summary
The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question[s] it aims to answer are: Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke Patients With Depression
- What is being tested?
- Group-based Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Aug 2021
- 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
- primary diagnosis of acute stroke, the last onset occurred within 2 weeks
- being over 18 years old
- scoring at least 8 on the HAMD scale
- Be conscious and able to communicate effectively with researchers
- Primary school education level or above, 6) having signed informed consent.
Who cannot join
- having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants
- a diagnosis of cognitive impairment
- receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms
- a history of drug abuse or dependence
Trial locations and contacts
1 site in 1 country.
China1 site
The PLA Rocket Force Characteristic Medical Center
Beijing, Beijing Municipality, 1000088
About this study
The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question[s] it aims to answer are:
- Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke,
- the interventional efficacy could be maintained at 3-month follow-up
- similar benefits would be observed for quality of life (QOL), sleep quality, psychological flexibility, cognitive fusion, and confidence.
The patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G-ACT and usual care support. the G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.
- Conditions
- Acute Stroke Patients With Depression
- Being tested
- Group-based Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Acceptance and Commitment TherapyBehavioural
G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | G-ACT Receives: Behavioral: Group-based Acceptance and Commitment Therapy |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression
Measured: immediately after the intervention
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression
Measured: 3 months after the intervention
Secondary outcomes (5)
Health-related quality of life (HRQoL)
physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL
Measured: immediately after and 3 months after the intervention
The Acceptance and Action Questionnaire II (AAQ-II)
the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility.
Measured: immediately after and 3 months after the intervention
The Cognitive Fusion Questionnaire (CFQ)
scores range from 0 to 63 with a higher score indicating more fused one is with one's thoughts
Measured: immediately after and 3 months after the intervention
The confidence was assessed using the Confidence after Stroke Measure (CaSM)
total scores ranging from 0 to 81 and higher scores representing higher confidence.
Measured: immediately after and 3 months after the intervention
The Pittsburgh Sleep Quality Index (PSQI)
total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality.
Measured: immediately after and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Aug 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Stroke Patients With DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLA Rocket Force Characteristic Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Liu Yun-e, PLA Rocket Force Characteristic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727358
- Sponsor's protocol ID
- Z181100001718041
- Status last verified
- Dec 2022
- First submitted
- 25 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu YE, Lv J, Sun FZ, Liang JJ, Zhang YY, Chen J, Jiang WJ. Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. Brain Behav. 2023 Dec;13(12):e3260. doi: 10.1002/brb3.3260. Epub 2023 Nov 8.
PubMed 37938871
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
- ClinicalTrials.gov ID
- NCT05727358
- Acronym / sponsor ID
- Z181100001718041
- Conditions
- Acute Stroke Patients With Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- PLA Rocket Force Characteristic Medical CenterUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 14 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.
The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question[s] it aims to answer are:
- Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke,
- the interventional efficacy could be maintained at 3-month follow-up
- similar benefits would be observed for quality of life (QOL), sleep quality, psychological flexibility, cognitive fusion, and confidence.
The patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G-ACT and usual care support. the G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Group-based Acceptance and Commitment TherapyG-ACT |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary diagnosis of acute stroke, the last onset occurred within 2 weeks
- being over 18 years old
- scoring at least 8 on the HAMD scale
- Be conscious and able to communicate effectively with researchers
- Primary school education level or above, 6) having signed informed consent.
Key exclusion criteria (4 listed)
- having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants
- a diagnosis of cognitive impairment
- receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms
- a history of drug abuse or dependence
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 |
|---|---|---|
| Group-based Acceptance and Commitment TherapyG-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial. | Behavioural | intervention group |
Primary outcome
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
Time frame: immediately after the intervention
Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
Time frame: 3 months after the intervention
Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression
5 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: immediately after and 3 months after the intervention
The Acceptance and Action Questionnaire II (AAQ-II)
Time frame: immediately after and 3 months after the intervention
The Cognitive Fusion Questionnaire (CFQ)
Time frame: immediately after and 3 months after the intervention
The confidence was assessed using the Confidence after Stroke Measure (CaSM)
Time frame: immediately after and 3 months after the intervention
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: immediately after and 3 months after the intervention
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 14 Feb 2023.
- Derived from this study: PubMed 37938871Liu YE, Lv J, Sun FZ, Liang JJ, Zhang YY, Chen J, Jiang WJ. Effectiveness of group acceptance and commitment therapy in treating depression for acute stroke patients. Brain Behav. 2023 Dec;13(12):e3260. doi: 10.1002/brb3.3260. Epub 2023 Nov 8.
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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 Group-based Acceptance and Commitment Therapy in people with Acute Stroke Patients With Depression, run by PLA Rocket Force Characteristic Medical Center at 1 site in China.
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 14 Feb 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 China. 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?
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item) (time frame: immediately after the intervention). 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 NCT05727358, which also lists 1 linked publication.
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 14 Feb 2023.