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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05665582
Other study ID # SSHF_58-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2017

Study information

Verified date January 2016
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study registration relates to a quantitative sub-study of a larger mixed method study, including also a qualitative sub-study. Together, these investigations will provide complementary insights. The quantitative study is a follow-up study of close relatives (> 16 years) of patients in treatment for substance use disorder (SUD) who participated in a group-based 4-day psychoeducational program.


Description:

The study is a follow-up study of close relatives (> 16 years) of patients in treatment for SUDs who participated in a group-based 4-day psychoeducational program. The investigators will examine whether the family intervention in the specialized treatment services has benefits in terms of typical patient reported outcomes; physical complaints, psychological functioning, family functioning and QoL. The data collection has been finalized in 2017.


Recruitment information / eligibility

Status Completed
Enrollment 271
Est. completion date December 31, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - All participants in a family program Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Family program
A 4-day psychoeducational family program.

Locations

Country Name City State
Norway Addiction Unit - Sørlandet Hospital Kristiansand Agder

Sponsors (1)

Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Vederhus JK, Kristensen O, Timko C. How do psychological characteristics of family members affected by substance use influence quality of life? Qual Life Res. 2019 Aug;28(8):2161-2170. doi: 10.1007/s11136-019-02169-x. Epub 2019 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver burden Changes in Codependency symptomatology measured with the Composite Codependency Scale (CCS). Participants indicate the extent to which they agreed with each statement on a scale of 1 (strongly disagree) to 5 (strongly agree). Changes from baseline to the 3 months follow-up
Primary Family functioning Changes in the general family functioning subscale (GFFS). Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed and a higher score indicated greater family dysfunction. Changes from baseline to the 3 months follow-up
Secondary Mental distress Changes in the the Hopkins Symptom Checklist (HSCL) 10-item version, which is used to measure mental distress. This 10-item index maps symptoms of anxiety (4 items) and depression (6 items) on 4-point Likert-type scales ranging from "not bothered at all" (1) to "extremely bothered" (4). The global severity index (GSI) constitutes the average of all items, with the highest score indicating greater symptom severity during the past week. Changes from baseline to the 3 months follow-up
Secondary Physical complaints Changes in physical complaints, measured on a 10-point ordinal scale (scaled 0 - 10) with higher score indicating more complaints. Changes from baseline to the 3 months follow-up
Secondary Well-being / quality of life Changes in Quality of Life measured with the QoL-5 scale (5 items). Responses are scored on a five-point scale ranging from very poor to very good QoL and then recoded into a decimal scale from 0.1 to 0.9, where 0.9 is the highest/best score and 0.1 the lowest/worst Changes from baseline to the 3 months follow-up
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