Clinical trial NCT05147077: Integrated Rehabilitation in Treating Post-stroke Anxiety
Official title: Integrated Rehabilitation in Treating Post-stroke Anxiety: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke
Anxiety
Keywords: post-stroke anxiety
integrated rehabilitation
acupuncture
traditional Chinese medicine
repetitive transcranial magnetic stimulation
randomized controlled trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 188
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-stroke anxiety (PSA) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSA exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality, and recurrence rates of stroke. Therefore, early clinical treatments for PSA are important to improve the prognosis and restore the social functions of stroke patients.

Integrated rehabilitation has significant advantages in the treatment of PSA. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSA. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed, treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.

Detailed description: This randomized controlled trial will enroll 188 PSA patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, and Jinhua Second Hospital. All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system. The primary outcome will be assessed by hamilton anxiety (HAMA) scale, self-rating anxiety scale (SAS), and activity of daily living (ADL) scale. Secondary outcomes will include montreal cognitive assessment (MoCA) scale, the simple fugl-meyer assessment of motor function (FMA) scale and pittsburgh sleep quality index (PSQI).

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with anxiety disorder, the type of depression and clinical syndrome of liver stagnation transforming into fire;
* Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) \> 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate \> 17, primary school level \> 20, secondary school level (including technical secondary school) \> 22, and college level (including junior college) \> 23 points;
* 25 \<= age \<= 85 years, male or female;
* First episode of stroke, no personal or family history of mental disability before the stroke;
* Anxiety level as mild or moderate (HAMA scores \>= 7 and \<= 21);
* Anxiety symptoms occur after the stroke in a clear temporal sequence;
* The course of the PSA is limited to 2 weeks to 36 months after the stroke;
* Participants can understand the study protocol and written informed consent is signed.

Exclusion Criteria:

* Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
* There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators and other electronic devices;
* Previous seizures, including primary and secondary seizures；
* Patients have severe complications in cardiovascular, liver, kidney or psychiatric history;
* There is a significant cognitive impairment (MMSE: literacy \<= 17, primary school level \<= 20, secondary school level (including technical secondary school) \<= 22, and college level (including junior college) \<= 23 points) or hearing impairment, aphasia;
* Coma, dying or chronic illness;
* Patients have taken psychotropic drugs or been treated for anxiety for nearly a month;
* People with unstable vital signs or patients with other mental disorders.

Primary outcomes:
measure: Change in hamilton anxiety (HAMA) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
measure: Change in self-rating anxiety scale (SAS)
timeFrame: Baseline, at 4-week during treatment
measure: Change in activity of daily living (ADL) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
Secondary outcomes:
measure: Change in Montreal cognitive assessment (MoCA) scale
timeFrame: Baseline, at 4-week during treatment
measure: Change in the Fugl-meyer assessment of motor function (FMA) scale
timeFrame: Baseline, at 4-week during treatment
measure: Change in Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: Third Affiliated Hospital of Zhejiang Chinese Medical University
name: Hong Gao, Deputy dean
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou J, Fan L, Hu H, Shen K, Wu L, Lin X, Gao H. The Efficacy of Integrated Rehabilitation for Post-Stroke Anxiety: Study Protocol for a Prospective, Multicenter, Randomized Controlled Trial. Int J Gen Med. 2022 Sep 6;15:7101-7111. doi: 10.2147/IJGM.S381434. eCollection 2022.