Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression

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 Overview

• Status: Completed
• Conditions: Acute Stroke Patients With Depression
• Intervention / Treatment: Behavioral: Group-based Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 1000088
      • The PLA Rocket Force Characteristic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. primary diagnosis of acute stroke, the last onset occurred within 2 weeks
2. being over 18 years old
3. scoring at least 8 on the HAMD scale
4. Be conscious and able to communicate effectively with researchers
5. Primary school education level or above, 6) having signed informed consent.

Exclusion Criteria:

1. having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants
2. a diagnosis of cognitive impairment
3. receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms
4. a history of drug abuse or dependence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: intervention group; G-ACT	Behavioral: Group-based Acceptance and Commitment Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	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.	immediately after and 3 months after the intervention

Collaborators and Investigators

• Sponsor: PLA Rocket Force Characteristic Medical Center
• Collaborators: Beijing Municipal Science & Technology Commission

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: Z181100001718041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No