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NCT Number: NCT07341425

Focused Acceptance and Commitment Therapy (FACT) for Stress, Anxiety, and Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trøjborg Lægehus

Aarhus C, 8000, Denmark

Location status: Recruiting

Location contact

Nanna Bjerg Ramsdal

CONTACT

[email protected]

42738777

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(i) age ≥ 18 years, (ii) clinically relevant symptoms of distress ≥ 4 [53] and either symptoms of anxiety measured with the Generalized Anxiety Disorders (GAD ≥ 9 [54]) questionnaire and/or symptoms of depression with assessed with the Patient Health Questionnaire (PHQ-9 ≥ 10 [55]) and/or symptoms of stress measured with the Perceived Stress Scale (PSS ≥ 14), (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with a video camera

Exclusion criteria

(i) currently receiving other psychotherapy or counseling for the same problem, (iii) a history of bipolar disorder, (ii) current or past psychotic disorder, (iv) substance abuse or dependence judged to require treatment, (v) suicide risk requiring immediate hospitalization.

Treatment and study plan

Focused Acceptance and Commitment Therapy

Other

Focused Acceptance and Commitment Therapy: This is a short-term treatment to alleviate symptoms of stress, anxiety, and depression.

Primary outcomes

  1. Disitress

    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.

    The Distress Thermometer [DT] measures participants' perceived level of psychological distress on a scale from 0 (no distress) to 10 (extreme distress).

  2. Depressive 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.

    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

  3. Anxiety

    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.

    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.

  4. 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.

    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

  1. Valuing Questionnaire

    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.

    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.
  2. 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.

    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.

  3. Distancing from thoughts

    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.

    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.

  4. Sense of Agency

    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.

    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.

  5. 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.

    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.

  6. Trust in the system

    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.

    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.

  7. Use of Health Services

    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.

    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).

  8. Physical activity

    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.

    Number of minutes spent on physical activity involving strength training, ball games or activities that raise your heart rate in the past week.

  9. Session duration

    Time frame: Assessed at every FACT session

    At each FACT session, the duration of time spent in-session will be recorded.

Other outcomes

  1. Working alliance

    Time frame: This questionnaire is only evaluated at the end of the first session

    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

  2. Harm

    Time frame: This questionnaire is administered only post-treatment: at 3 months for the FACT group and at 7 months for the waitlist group.

    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).

  3. Feasibility: within-group effect

    Time frame: Will happen after the therapy has ended.

    The following feasibility criteria will be evaluated: 1) within-group effect of Cohen's d >.5,

  4. Fidelity to the intervention

    Time frame: Will happen after the therapy has ended.

    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.

  5. Minimal harm

    Time frame: This questionnaire is administered only post-treatment, at 3 months for the FACT group and at 7 months for the waitlist group.

    Minimal harm evaluated with NEQ

  6. Propective acceptability

    Time frame: CEQ will be measured at post session one.

    Prospective acceptability: Credibility/Expectancy Questionnaire for evaluating expected improvement of therapy [CEQ] will be measured post session one.

  7. Retrospective acceptability

    Time frame: CSQ-8 will be measured at post treatment: 3 months for the FACT group and 7 months for the waitlist group.

    Retrospective acceptability: Client Satisfaction Questionnaire [CSQ-8], interest and usefulness of intervention [73].

Study contacts

Contact information is provided by the study sponsor or research team.

Mia Skytte O'Toole, Ph.D.

CONTACT

[email protected]

+4587165289

Nanna Bjerg Ramsdal, MSc

CONTACT

[email protected]

+4542738777

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

A Study Protocol for a Randomized Controlled Study of Focused Acceptance and Commitment Therapy (FACT)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.