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Completed

NCT Number: NCT05727358

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.

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Key information

Conditions

Acute Stroke Patients With Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The PLA Rocket Force Characteristic Medical Center

Beijing, Beijing Municipality, 1000088, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Group-based Acceptance and Commitment Therapy

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: immediately after and 3 months after the intervention

    physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL

  2. The Acceptance and Action Questionnaire II (AAQ-II)

    Time frame: immediately after and 3 months after the intervention

    the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility.

  3. The Cognitive Fusion Questionnaire (CFQ)

    Time frame: immediately after and 3 months after the intervention

    scores range from 0 to 63 with a higher score indicating more fused one is with one's thoughts

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

    Time frame: immediately after and 3 months after the intervention

    total scores ranging from 0 to 81 and higher scores representing higher confidence.

  5. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: immediately after and 3 months after the intervention

    total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality.

Sponsors and collaborators

Lead sponsor

PLA Rocket Force Characteristic Medical Center

Other

Collaborators

  • Beijing Municipal Science & Technology Commission

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2023
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.