About this trial
This study is an interventional study examining the feasibility and acceptability of Focused Acceptance and Commitment Therapy (FACT) as a short-term intervention. Sixty participants will be randomized to either an intervention group (FACT; receiving a maximum of 250 min treatment) or a waitlist control group (receiving treatment after four months). Inclusion criteria are elevated symptoms of anxiety (GAD-7 ≥ 9), depression (PHQ-9 ≥ 10), and/or stress (PSS ≥ 14). Participants will complete self-report questionnaires at baseline, post-treatment, and at 1- and 3-month follow-ups. Additionally, brief session questionnaires will be completed before and after each session. Recruitment will take place through general practi-tioners in the Aarhus area.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Focused Acceptance and Commitment Therapy
Other interventionFocused Acceptance and Commitment Therapy: This is a short-term treatment to alleviate symptoms of stress, anxiety, and depression.
Treatment groups
Trial outcomes
Primary outcomes
Disitress
The Distress Thermometer \[DT\] measures participants' perceived level of psychological distress on a scale from 0 (no distress) to 10 (extreme distress).
Depressive symptoms
Patient Health Questionnaire-9 \[PHQ-9\] consists of nine items and is rated on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating more severe depression
Anxiety
General Anxiety Disorder-7 \[GAD-7\] consists of 7 items scored from 0 (not at all) to 3 (nearly every day) with scores ranging from 0 to 21. Higher scores reflect more severe anxiety symptoms.
Stress
Perceived Stress Scale-10 \[PSS-10\]. The scale consists of ten items rated from 0 (never) to 4 (very often), producing a total score between 0 and 40. Higher scores reflect greater levels of perceived stress.
Secondary outcomes
Valuing Questionnaire
Valuing Questionnaire \[VQ\] consists of ten items rated on a seven-point Likert scale from 0 (not at all) to 6 (completely true). The measure yields two subscales: Progress and Obstruction. * Progress (items, 3, 4, 5, 7,9. Range = 0 to 30) defined as enactment and perseverance in living consistently with one's values. Higher scores represent a closer alignment between one's internal values and one's actions. * Obstruction (items 1, 2, 6, 8, 10. Range = 0 to 30) represents the extent to which various disruptions got in the way of valued living. Higher scores represent more interference with living consistently with one's values.
Experiential avoidance
The Brief Experiential Avoidance Questionnaire \[BEAQ\] consists of 15 items rated on a six-point Likert scale from 1 (strongly agree) to 6 (strongly disagree), yielding total scores between 15 and 90. Higher scores reflect greater levels of experiential avoidance.
Distancing from thoughts
The Experience Questionnaire \[EQ\] includes 11 items on the decentering scale, each rated on a 5-point Likert scale from 1 (never) to 5 (all the time). Scores on the 11 items are summed to produce a total scale score, which can range from 11 to 55, with higher scores indicating greater levels of decentering.
Sense of Agency
The Sense of Agency Scale \[SoA\] consisting of 13 items with responses recorded on a scale from 1 (strongly disagree) to 7 (strongly agreee). It measures Sense of Positive Agency (SoPA) and Sense of Negative Agency (SoNA). SoPA refers to a person's experience of having control over their body, thoughts, and environment. SoNA, in contrast, describes the experience of feeling that these aspects are not under one's control.
Other outcomes
Working alliance
Working Alliance Inventory - Short Revised \[WAI-SR\] consists of 12 items, each rated on a 5-point Likert scale from 1 (seldom) to 5 (always). Total scores range from 12 to 60, with higher scores indicating a stronger therapeutic alliance
Harm
The Negative Effects Questionnaire \[NEQ\] consists of 20 items and is a self-report measure comprising three parts. First, respondents indicate whether each negative effect occurred during treatment using a yes/no format (coded as 1/0). Second, they rate the severity of each endorsed negative effect on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"), with higher scores reflecting greater severity. Third, respondents attribute each negative effect either to "the treatment I received" (coded as 1) or to "other circumstances" (coded as 0).
Feasibility: within-group effect
The following feasibility criteria will be evaluated: 1) within-group effect of Cohen's d \>.5,
Fidelity to the intervention
Fidelity of the interventions. Fidelity assessment of session recordings will include two components: 1) adherence to key FACT principles (i.e., whether the key therapeutic elements were delivered as intended) and 2) therapist competency, with both aspects rated on a 0-2 scale. Two independent raters will evaluate a random sample of 20% of cases in the FACT group, covering all sessions for each selected participant.
Sponsors and contacts
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