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

NCT07341425 | Recruiting

• 1 other identifier: 1-10-72-145-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wailist; Focused Acceptance and Commitment Therapy (FACT)

Keywords

FACT; Focused Acceptance and Commitment Therapy; Brief interventions

Outcome Measures

Primary Outcomes (4)

• Disitress

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

  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

  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.

  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.

  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.

Secondary Outcomes (9)

• Valuing Questionnaire

  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

  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

  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

  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

  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.

Other Outcomes (7)

• Working alliance

  This questionnaire is only evaluated at the end of the first session

• Harm

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

• Feasibility: within-group effect

  Will happen after the therapy has ended.

Study Arms (2)

Focused Acceptance and Commitment Therapy (FACT)

EXPERIMENTAL

The intervention is focused on cultivating three fundamental skills in FACT: 1) Openness 2) Awareness, and 3) Engagement. Individuals characterized by inflexibility tend to suffer because they suppress, control, or avoid private experiences (lack in openness), they overidentify with past/future thinking (lack in awareness), and/or disconnection from their values (lack in engagement). Participants randomized to the FACT group will receive therapy corresponding to a maximum of five sessions of up to 50 minutes each with up to 250 minutes of contact (e.g., 5 sessions of 50 minutes or brief phone sessions), which will be delivered flexibly across the three-month intervention period. Both the number and duration of sessions may vary based on participant needs, provided that the total therapy time does not exceed 250 minutes.

Other: Focused Acceptance and Commitment Therapy

Wailist

NO INTERVENTION

The waitlist group will receive FACT after four months.

Interventions

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.

Focused Acceptance and Commitment Therapy (FACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Trøjborg Lægehus

Aarhus C, 8000, Denmark

RECRUITING

Central Study Contacts

Nanna Bjerg Ramsdal, MSc

CONTACT

+4542738777; nannabjerg@psy.au.dk

Mia Skytte O'Toole, Ph.D.

CONTACT

+4587165289; mia@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant information material intentionally omits detailed information about the FACT intervention and the specific aims of, for instance, comparing immediate versus waitlist. Instead, participants are informed that there is currently insufficient evidence to determine whether it is more beneficial to begin treatment immediately or after a waiting period, with good reasons to believe in both scenarios. This intentional concealment is deemed necessary to prevent potential expectation biases that could arise from participants' awareness of whether they will begin treatment immediately or wait, and how this might influence their perceptions of the potential benefits and drawbacks of the timing of therapy initiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-01

Locations

DK (1)