NCT05541523

Brief Summary

CBT: cognitive behavioural therapy MBT: mindfulness-based therapy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 12, 2022

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    The Hamilton Anxiety Rating Scale (HAM-A), developed by Hamilton in 1959,26 was used in this study to assess the anxiety level of the patients. The HAM-A contains 14 items, each scored on a 5-point scale (0, asymptomatic; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; 4, extremely severe symptoms). The total sum score, ranging from 0 to 56, can be classified into four levels: 0, no anxiety symptoms; 1-17, mild anxiety; 18-24, moderate anxiety; 25-56, severe anxiety.

    up to 8 weeks

  • Emotional labor

    Chinese version scale of emotional labor(C-ELS). Permission to use the Chinese version of the instruments was obtained. To the best of our knowledge, this is the first time these questionnaires are used in palliative care programs in China, using a five-point Likert type scale ("1" = "strongly disagree," "7" = "strongly agree"). The scale divided emotional labor into four part surface acting, deep acting, expression of naturally felt emotions and emotion termination. The Cronbach's α of surface acting, deep acting, expression of naturally felt emotions and emotion termination were 0.714, 0.743, 0.846, 0.758, respectively.

    up to 8 weeks

  • Self-Efficacy

    Occupational Coping Self-Efficacy Scale for Nurses ( OCSE-N, Occupational Coping Self-Efficacy Scale for Nurses ), a total of 9 items, using Likert 5-level scoring method, 1 means ' can not easily deal with ' to 5 means ' can easily deal with ', the total score range of 9 to 45 points, the higher the score, the higher the occupational coping self-efficacy of nurses.

    up to 8 weeks

Study Arms (2)

cognitive behavioural therapy

EXPERIMENTAL
Behavioral: mindfulness-based therapy

mindfulness-based therapy

EXPERIMENTAL
Behavioral: cognitive behavioural therapy

Interventions

The three therapists in the cognitive behavioural group therapy condition were two students of master's degree of nursing with formal education in cognitive therapy and one psychological specialist nurse working in a palliative care unit. There was no evidence of significant deviation from the protocol.

mindfulness-based therapy

The two therapists in the mindfulness-based stress reduction condition were one clinical psychologist and one student of master's degree of nursing with formal education in mindfulness.Both interventions were manualized. To assure adherence to the study protocol meetings between the therapists and the researchers were organized regularly and the therapists detailed the content of each group session in clinical records which were frequently monitored by a research assistant.

cognitive behavioural therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) Eligible participants were the nurses who nursing patients with stage IV cancer or other incurable diseases;
  • (2) agree to participate in this research;
  • (3) no history of mental illness.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210001, China

RECRUITING

Wu Ye

Nanjing, Jiangsu, 210001, China

RECRUITING

MeSH Terms

Conditions

DeathDepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

May 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 1, 2023

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations