NCT06044363

Brief Summary

Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. It offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. The aim of the study is to investigate the acceptability and preliminary efficacy of the Satir model on self-esteem, mental health, and family function among individuals with SUD in China. The study will adopt a mixed-method approach. The quantitative phase will employ a randomized control trial (RCT) utilizing a pre-post study design. The qualitative phase will involve conducting semi-structured individual interviews.The data will be analyzed by using SPSS software package (IBM SPSS statistics version 26.0). The individual-interview will be analyzed by using the six-phase thematic analysis. The study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with SUD. It can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

8 days

First QC Date

September 11, 2023

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-esteem

    The changes of participants' self-esteem will be assessed by using the Chinese version of Rosenberg self-esteem scale. Total scores range from 10 to 40, with higher scores representing lower self-esteem.

    Through study completion, an average of two months

Secondary Outcomes (9)

  • Adult attachment

    Through study completion, an average of two months

  • Coping style

    Through study completion, an average of two months

  • Self-efficacy

    Through study completion, an average of two months

  • Meaning in life

    Through study completion, an average of two months

  • Resilience

    Through study completion, an average of two months

  • +4 more secondary outcomes

Study Arms (2)

Satir group

EXPERIMENTAL

Participants in the intervention group will receive a 10-session Satir model intervention.

Other: Satir group

Control group

NO INTERVENTION

Participants in the control group will receive care as usual.

Interventions

Participants in the intervention group will receive a 10-session, 3-hour/session intervention that spans over a period of five days (2 sessions/day). The intervention program will be conducted on specific weekends, with a gap of 1 to 2 weeks. The total duration of the intervention will be 30 hours.

Satir group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 or above;
  • are able to speak, read, and write Chinese;
  • are willing to participate in the study and share their experience of the intervention with the research group;
  • have informed consent to participate in the study.

You may not qualify if:

  • have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder;
  • have a diagnosed memory and cognitive impairment;
  • are undergoing psychotherapeutic or psychopharmacologic treatment;
  • are participating in similar studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fangqiang compulsory isolation detoxification center

Yancheng, Jiangsu, 224000, China

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Haixia Ma, PhD

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Open trial
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a single center, open-label, randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

September 9, 2023

Study Completion

September 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The relevant anonymized participant-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.

Shared Documents
SAP, ICF, CSR
Time Frame
After the project is completed and the results of the project have been published.
Access Criteria
Request could be sent to Principal Investigator (phxma@hkmu.edu.hk)

Locations