NCT05703529

Brief Summary

A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. A total of 80 only-child-lost people who met the inclusion and exclusion criteria were expected to recruit. There were six weeks in the intervention, including positive introduction, positive reaction, gratitude, meaningful, three good things, and using personal strength. The measurements were conducted at the baseline, immediately after the intervention, 3-month after the intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

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

March 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 20, 2022

Last Update Submit

January 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of psychological resilience

    It is assessed by Connor-Davidson Resilience Scale. A higher score suggests a higher level of psychological resilience. The range is 0-100.

    Baseline, immediately after the intervention, 3-month after the intervention

Secondary Outcomes (5)

  • Change of depressive symptoms

    Baseline, immediately after the intervention, 3-month after the intervention

  • Change of index of well-being

    Baseline, immediately after the intervention, 3-month after the intervention

  • Change of Dehydroepiandrosterone (DHEA) in saliva

    Baseline, immediately after the intervention, 3-month after the intervention

  • Change of Sleep Quality

    Baseline, immediately after the intervention, 3-month after the intervention

  • Change of Social Avoidance and Social Distress

    Baseline, immediately after the intervention, 3-month after the intervention

Study Arms (2)

Positive Psychotherapy group

EXPERIMENTAL
Behavioral: Positive Psychotherapy

Control group

OTHER

Usual Care means treating as usual, including a regular home visit.

Other: Usual Care

Interventions

A 6-week group-based positive psychotherapy was conducted in this group. The themes of each week include positive introduction, three good things and positive reactions, gratitude, positive memory, identifying personal strengths and utilizing strengths.

Positive Psychotherapy group

Usual Care means treating as usual, including a regular home visit.

Control group

Eligibility Criteria

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

You may qualify if:

  • having only one child or legally adopting;
  • No surviving children;
  • basic language expression and comprehension skills;
  • the score of Connor-Davidson Resilience Scale is lower than 82

You may not qualify if:

  • in the acute bereavement period (\<6 months);
  • unable to participate in activities due to severe physical illness;
  • having diagnosis of sever mental illness;
  • receiving other psychological therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The intervention provider, investigator, and outcomes assessor have not been informed of the group allocation, but the participants may be aware of the group allocation because of the nature of the research design.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xiangya School of Nursing

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 30, 2023

Study Start

March 1, 2016

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

January 30, 2023

Record last verified: 2023-01