- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05703529
Group-based Positive Psychotherapy in Psychological Resilience of Only-Child-Lost People
January 19, 2023 updated by: Zhang Wen, Central South University
The Impact of Group-based Positive Psychotherapy in Psychological Resilience of Only-child-lost People: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
49 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Positive Psychotherapy group
|
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.
|
|
Other: Control group
Usual Care means treating as usual, including a regular home visit.
|
Usual Care means treating as usual, including a regular home visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of psychological resilience
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of depressive symptoms
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
It is measured by Zung Self-rating Depression Scale with a higher score suggesting a more severe of depressive symptoms
|
Baseline, immediately after the intervention, 3-month after the intervention
|
|
Change of index of well-being
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
It is measured by Campbell's Index of Well-being.
A high score indicates a high level of well-being.
|
Baseline, immediately after the intervention, 3-month after the intervention
|
|
Change of Dehydroepiandrosterone (DHEA) in saliva
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
Saliva is collected using a saliva collector and assayed using the Elisa assay.
After the specimens were collected, they were tested with the Elisa kit of Salimetrics® according to its instructions.
|
Baseline, immediately after the intervention, 3-month after the intervention
|
|
Change of Sleep Quality
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
It is measured by Pittsburgh Sleep Quality Index.
If the total score is over 7, the sleep quality is normal, and if the score is over 7, it suggests a low sleep quality
|
Baseline, immediately after the intervention, 3-month after the intervention
|
|
Change of Social Avoidance and Social Distress
Time Frame: Baseline, immediately after the intervention, 3-month after the intervention
|
It is measured by Social Avoidance and Distress Scale.
A high score indicates a high level of social avoidance and social distress.
|
Baseline, immediately after the intervention, 3-month after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
October 31, 2016
Study Completion (Actual)
October 31, 2016
Study Registration Dates
First Submitted
December 20, 2022
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Estimate)
January 30, 2023
Study Record Updates
Last Update Posted (Estimate)
January 30, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2015058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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