Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders

Mental Health Wellness 1 Clinical Trial

Official title:

Assessing the Efficacy and Acceptability of the Satir Model on Self-esteem and Mental Health Among Individuals With Substance Use Disorders in China: A Pilot Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044363
• Other study ID #: HE-SF2023/26
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Hong Kong Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 30, 2023
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged 18 or above;

2. are able to speak, read, and write Chinese;

3. are willing to participate in the study and share their experience of the intervention with the research group;

4. have informed consent to participate in the study.

Exclusion Criteria:

1. have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder;

2. have a diagnosed memory and cognitive impairment;

3. are undergoing psychotherapeutic or psychopharmacologic treatment;

4. are participating in similar studies.

Related Conditions & MeSH terms

• Drug Abuse
• Family Dysfunction
• Mental Health Wellness 1
• Self Esteem
• Substance-Related Disorders

Intervention

Other:
• Satir group
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.

Locations

Country	Name	City	State
China	Fangqiang compulsory isolation detoxification center	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adult attachment	Adult attachment will be assessed by using Adult attachment scale (AAS).The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant".	Through study completion, an average of two months
Secondary	Coping style	Coping style via Chinese version of simplified coping style questionnaire (SCSQ). It consists of 20 items referring to different ways of coping, with a total score range from 0 to 60. Two subscales are active coping and passive coping.	Through study completion, an average of two months
Secondary	Self-efficacy	self-efficacy will be assessed by the general self-efficacy scale (GSES). The total score range from 10 to 40. Higher scores indicate higher perceived general self-efficacy	Through study completion, an average of two months
Secondary	Meaning in life	Meaning in life will be assessed by using the Chinese version of meaning in life questionnaire (MLQ). It includes 10 items with a total score range from 10 to 70. It consists two subscales: MLQ Presence (MLQ-P) and Search (MLQ-S), each of them containing five items. The internal consistency of MLQ is 0.819.	Through study completion, an average of two months
Secondary	Resilience	Resilience will be assessed via. the 25-item Connor-Davidson Resilience Scale (CD-RISC-25). The items are evaluated on a five-point likert scale ranging from 1 to 4. These ratings result in a number between 0-100, and higher scores indicate higher resilience.	Through study completion, an average of two months
Secondary	Positive and negative affect scale	Positive and negative affect scale via Positive and negative affect scale (PANAS). This brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.	Through study completion, an average of two months
Secondary	Drug craving	Drug craving will be assessed via the drug craving scale. It measures five dimensions of substance craving, including (1) prizing substance craving; (2) reflecting substance craving; (3) social substance craving; (4) negative substance craving; and (5) eliminating substance craving. The items are evaluated on a seven-point likert scale ranging from 1(strongly disagree) to 7 (strongly agree),	Through study completion, an average of two months
Secondary	Motivation to abstain from drugs	Motivation to abstain from drugs will be assessed via the motivation to abstain from drugs. It includes 31 items, The items are evaluated on a five-point likert scale ranging from 1(strongly disagree) to 5 (strongly agree), with higher score indicates higher level of motivation to abstain from drugs.	Through study completion, an average of two months
Secondary	Family function	Family function via the Chinese version of the 60-item McMaster Family Assessment Device (FAD). It includes seven subscale: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general function. The higher the overall score, the worse the level of family function.	Through study completion, an average of two months