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.
The present study seeks to evaluate the feasibility, acceptability, and preliminary efficacy of FACT as a short-term, delivered-as-needed intervention (up to 5 sessions) compared to a waitlist group (receiving treatment as usual (TAU) during the waiting period). Specifically, the project aims to assess the feasibility of implementing FACT within a primary mental health care setting, its acceptability to individuals experiencing heightened distress, its potential to alleviate distress and improve psychological flexibility, and to explore when these changes occur. The hypotheses for this study are as follows: * Hypothesis 1: FACT is feasible and acceptable for treating people with psychological distress. * Hypothesis 2: FACT will be more effective in reducing symptoms of psychological distress than the waitlist-group. * Hypothesis 3: Clients receiving FACT will report greater psychological flexibility, sense of agency, and self-efficacy compared to the waitlist-group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Focused Acceptance and Commitment Therapy: This is a short-term treatment to alleviate symptoms of stress, anxiety, and depression.
Trøjborg Lægehus
Aarhus C, Denmark
RECRUITINGDisitress
The Distress Thermometer \[DT\] measures participants' perceived level of psychological distress on a scale from 0 (no distress) to 10 (extreme distress).
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group. Assessments are also measured at the beginning of each FACT session.
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
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group. Assessments are also measured at the beginning of each FACT session.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group. Assessments are also measured at the beginning of each FACT session.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group. Assessments are also measured at the beginning of each FACT session.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments were conducted at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group.
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.
Time frame: Assessed at baseline; 3-months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8, and 10 months for the waitlist group.
Self-compassion
The Self Compassion Scale - short revised \[SCS - SF\] is rated on a five-point Likert scale (1 = almost never, 5 = almost always), with higher total scores indicating higher self-compassion.
Time frame: Assesed at baseline; 3 months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8 and 10 months for the waitlist group.
Trust in the system
The Health Confidence Score \[HCS\] s rated on a four-point Likert scale. For analysis, response options are scored from 0 to 3, with 'strongly agree' = 3, 'agree' = 2, 'neutral' = 1, and 'disagree' = 0. Higher scores indicate greater health confidence.
Time frame: Assesed at baseline; 3 months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8 and 10 months for the waitlist group.
Use of Health Services
Participants will be asked to report whether they receive any (additional) treatment related to the present-ing issue for which they initially sought help, and if so, the type and number of visits during the interim pe-riod. Reported treatments will be categorized into four types of health services: (1) Psychological services (e.g., sessions with a psychologist or psychotherapist); (2) Medical services (e.g., consultations with a psy-chiatrist, including pharmacological treatment); (3) Alternative treatments (e.g., reflexology, craniosacral therapy); and (4) Physical health services (e.g., physiotherapy or chiropractic care).
Time frame: For the FACT group, assessments will be conducted post-treatment at 3 months and at follow-up at 4 months. For the waitlist group, assessments will be conducted at 3, 4, 7, and 8 months.
Physical activity
Number of minutes spent on physical activity involving strength training, ball games or activities that raise your heart rate in the past week.
Time frame: Assesed at baseline; 3 months post-intervention; follow-up at 4 months. Additional assessments at 6 months for the FACT group and at 7, 8 and 10 months for the waitlist group.
Session duration
At each FACT session, the duration of time spent in-session will be recorded.
Time frame: Assessed at every FACT session
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