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

NCT ID: NCT07341425

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2028-06-30

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.

Detailed Description

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.

Conditions

Focused Acceptance and Commitment Therapy (FACT); Wailist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Focused Acceptance and Commitment Therapy (FACT)

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.

Group Type: EXPERIMENTAL

Focused Acceptance and Commitment Therapy

Intervention Type: OTHER

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

Wailist

The waitlist group will receive FACT after four months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Focused Acceptance and Commitment Therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Nanna Bjerg Ramsdal, MSc

Role: CONTACT

nannabjerg@psy.au.dk

+4542738777

Mia Skytte O'Toole, Ph.D.

Role: CONTACT

mia@psy.au.dk

+4587165289

Other Identifiers

1-10-72-145-25

Identifier Type: -

Identifier Source: org_study_id