NCT05410119

Brief Summary

Two communities in Changsha was selected, where principle investigators' institution located, to recruit 80 participants into intervention group and control group. Resilience therapy group was intervened by a psychotherapy developed by the researchers, which lasts 8 weeks. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up. Measurement was conducted before the intervention, immediately after intervention, 3-month after intervention, and 12-month after intervention. A questionnaire was used during each measurement, including several scales in it, including resilience and depression.The saliva test of Dehydroepiandrosterone was also done in each measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2017

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

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 27, 2022

Last Update Submit

June 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change of resilience

    A kind of ability to bounce back from adversity measured by Connor-Davidson Resilience Scale, with higher score reflecting higher level of resilience, ranging from 0-100.

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention

  • Change of depression

    Depressive mood in recent two weeks measured by Zung Self-rated Depression Scale, with higher score reflecting higher level of depression, ranging from 0-80.

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

Secondary Outcomes (5)

  • Change of subjective well-being

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

  • Change of social avoidance

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

  • Change of sleeping quality

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

  • Change of post traumatic growth

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

  • Change of concentration of dehydroepiandrosterone in saliva

    Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.

Study Arms (2)

Resilience group

EXPERIMENTAL
Behavioral: 8-week Resilience Group Psychotherapy

Controlled group

ACTIVE COMPARATOR
Other: Usual care

Interventions

Resilience Group Psychotherapy was intervened by a psychotherapy developed by the researchers. The resilience promotion therapy lasts 8 weeks, and also has a group intervention in each week. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up.

Resilience group

Usual care means treating as usual, such as regular home visit.

Controlled group

Eligibility Criteria

Age49 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • had only one child but now passed away;
  • failed to have another children;
  • volunteered to participate;
  • the score of resilience was under 72 points indicating a lower or middle level

You may not qualify if:

  • in the acute bereavement period (\<6 months);
  • unable to participate in activities due to severe physical illness;
  • receiving drug treatment for mental illness;
  • receiving other psychological therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 8, 2022

Study Start

November 1, 2017

Primary Completion

January 30, 2018

Study Completion

January 30, 2019

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations