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CompletedNCT05665582Updated Jan 4, 2023

Family Members Affected by Substance Use Disorder - a Follow-up Study

An observational study in Caregiver Burden, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Sorlandet Hospital HF · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
271
Ages
16 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 271 is close to the median of 250 across 296 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Sorlandet Hospital HF is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Family members of patients in treatment for SUD at a Norwegian addiction treatment unit. The family members participated in a 4-day psychoeducational program

Inclusion criteria

  • All participants in a family program

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
271 participants (actual)
Patient registry
No

Groups and cohorts

  • Affected family members of patients with Substance use disorders

    The family sample was recruited from at a Norwegian addiction treatment unit where close relatives of patients in treatment for SUD participated in a family program.

    Other: Family program

Interventions

  • OtherFamily program

    A 4-day psychoeducational family program.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Changes from baseline to the 3 months follow-up

  2. 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.

    Time frame: Changes from baseline to the 3 months follow-up

Secondary outcomes

  1. 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.

    Time frame: Changes from baseline to the 3 months follow-up

  2. Physical complaints

    Changes in physical complaints, measured on a 10-point ordinal scale (scaled 0 - 10) with higher score indicating more complaints.

    Time frame: Changes from baseline to the 3 months follow-up

  3. 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

    Time frame: Changes from baseline to the 3 months follow-up

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Study locations

1 site
  • Addiction Unit - Sørlandet Hospital
    Kristiansand, Agder 4600, Norway
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References and documents

Publications

  • 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. PubMed 30895489 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05665582
Lead sponsor
Sorlandet Hospital HF
Responsible party
Sponsor
First posted
Dec 27, 2022
Start date
Jan 1, 2016
Primary completion
Jun 30, 2017
Completion
Dec 31, 2017
Last update
Jan 4, 2023

Study contacts

John-Kåre Vederhus, PhD
principal investigator · Sørlandet Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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