Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Quality of life (QoL) |
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL. |
After the intervention (approx 5 months) |
|
Primary |
Quality of life at 3 months follow up |
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL. |
Short term outcome - 3 months follow-up |
|
Primary |
Quality of life at 12 months follow-up |
QoL is measured with the Quality of Life 5 scale (QoL-5). QoL-5 consists of five subjective statements: two questions are about health, physical and mental; two questions address the quality of significant relationships (partner and friends); and one question addresses the existential self i.e. the relationship with oneself. Responses are scored on a 5-step ordinal scale from 1 to 5. A score of 1 is very good, and 5, very poor. The scores are transposed, and inverted into a decimal scale ranging from 0.1 to 0.9; 0.9 is now the best score and 0.1, the worst. Mean scores for health and relationship QoL are calculated, and a total QoL score is calculated as a mean of health, relationship and existential QoL. Normative data from a previous survey of the general population showed a mean QoL score of 0.69 and a minimal clinically important difference is 0.10. |
Long-term outcome - 12 months follow-up |
|
Secondary |
Perceived functioning/well-being |
Perceived functioning/well-being will be measured with the Outcome rating scale (ORS). The ORS each consist of four 10-cm visual analog scales (VAS) ranging from negative (left) to positive (right). The ORS measures three areas of client functioning: individual, interpersonal, and social, as well as measuring the client's overall view of their personal well-being. The marks made by clients on each of the four lines are measured to the nearest millimeter to derive the score. These are then summed to obtain a total score. Cm is analogue to scale score and the total score range from 0 to 40. High scores reflect a good level of well-being and functioning. A clinical cut-off is 25 (i.e., one would expect scores below 25 in a clinical sample) and a 5 point difference in score is consider as the minimal clinically important difference |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|
Secondary |
Perceived psychological distress |
Perceived psychological distress measured with the Symptom Check List - 10 (SCL-10), a short-form of the Hopkins Symptom Checklist 90. SCL-10 has 10 items about anxiety (4 items) and depression (6 items). Responses are scored on an ordinal scale from 1 to 4, with the highest score indicating highest distress. A total mean score is calculated. Scores above 1.85 is considered a pathological score. |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|
Secondary |
Substance use |
Substance use will be assessed with the European version of the Addiction Severity index (EuropASI). Data on drug and alcohol use in the 30 days before the interview are used to derive a composite score to indicate severity; scores range from 0 (no problem) to 1 (a severe problem). |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|
Secondary |
Physiological variables |
Sleep quality will be assessed using a 10-cm visual analog scale (VAS) ranging from negative (left) to positive (right). |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|
Secondary |
Drop-out |
Drop-out rates from the out-patient treatment, i.e., the percentage who has dropped-out of treatment in each group. |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|
Secondary |
Restlessness & trepidation |
Restlessness & trepidation will be assessed using a 10-cm visual analog scales (VAS) ranging from negative (left) to positive (right). |
After the intervention (approx 5 months) and 3 & 12 months follow-up |
|