NCT05727358

Brief 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,
  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration 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

August 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
Last Updated

February 14, 2023

Status Verified

December 1, 2022

Enrollment Period

3.1 years

First QC Date

January 25, 2023

Last Update Submit

February 3, 2023

Conditions

Acute Stroke Patients With Depression

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    3 months after the intervention

Secondary Outcomes (5)

  • Health-related quality of life (HRQoL)

    immediately after and 3 months after the intervention

  • The Acceptance and Action Questionnaire II (AAQ-II)

    immediately after and 3 months after the intervention

  • The Cognitive Fusion Questionnaire (CFQ)

    immediately after and 3 months after the intervention

  • The confidence was assessed using the Confidence after Stroke Measure (CaSM)

    immediately after and 3 months after the intervention

  • The Pittsburgh Sleep Quality Index (PSQI)

    immediately after and 3 months after the intervention

Study Arms (2)

intervention group

EXPERIMENTAL

G-ACT

Behavioral: Group-based Acceptance and Commitment Therapy

control group

NO INTERVENTION

Interventions

Group-based Acceptance and Commitment TherapyBEHAVIORAL

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.

intervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The PLA Rocket Force Characteristic Medical Center

Beijing, Beijing Municipality, 1000088, China

Location

Related Publications (1)

  • 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.

    PMID: 37938871DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head nurse

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 14, 2023

Study Start

August 1, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

February 14, 2023

Record last verified: 2022-12

Locations

CN(1)