Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Swedish Acceptance and Action Questionnaire (SAAQ) |
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility. |
Baseline and end of treatment (baseline+3-16 weeks) |
|
| Secondary |
Change in Swedish Acceptance and Action Questionnaire (SAAQ) |
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility. |
Baseline and follow up (6 weeks after end of treatment) |
|
| Secondary |
Change in Swedish Acceptance and Action Questionnaire (SAAQ) |
Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility. |
End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment) |
|
| Secondary |
Change in Generalized Anxiety Disorder 7 (GAD-7) |
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety. |
Baseline and end of treatment (baseline+3-16 weeks) |
|
| Secondary |
Change in Generalized Anxiety Disorder 7 (GAD-7) |
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety. |
Baseline and follow up (6 weeks after end of treatment) |
|
| Secondary |
Change in Generalized Anxiety Disorder 7 (GAD-7) |
Measures self-reported severity and frequency of symptoms of generalized anxiety disorder over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 7 items. Each item is scored from 0-3 (0=never, 3=daily), yielding a total between 0 and 21 where a higher number indicates a higher severity of the patient's anxiety. |
End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment) |
|
| Secondary |
Change in Patient Health Questionnaire 9 (PHQ-9) |
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression. |
End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment) |
|
| Secondary |
Change in Patient Health Questionnaire 9 (PHQ-9) |
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression. |
Baseline and follow-up (6 weeks after end of treatment) |
|
| Secondary |
Change in Patient Health Questionnaire 9 (PHQ-9) |
Measures self-reported presence and severity of symptoms of depression over the last 2 weeks on a 4-point likert scale. The questionnaire includes a total of 9 items. Each item is scored from 0-3 (0=not at all, 3=nearly every day), yielding a total between 0 and 27 where a higher number indicates more severe symptoms of depression. |
Baseline and end of treatment (baseline + 3-16 weeks) |
|
| Secondary |
Change in RAND 36-item Health Survey (RAND-36) |
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best. |
Baseline and end of treatment (baseline + 3-16 weeks) |
|
| Secondary |
Change in RAND 36-item Health Survey (RAND-36) |
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best. |
Baseline and follow up (6 weeks after end of treatment) |
|
| Secondary |
Change in RAND 36-item Health Survey (RAND-36) |
Measures self-reported health related quality of life. The questionnaire includes a total of 35 items within 8 subscales (physical function, physical role-function, emotional role-function, social function, psychological well-bering, vitality, pain and general health). For each scale, using the standardised score calculation, a scale score is given between 0 and 100, where 0 is worse and 100 is best. |
End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment) |
|
