A Study Protocol for a Randomized Controlled Study of Focused Acceptance and Commitment Therapy (FACT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Disitress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Wailist
The waitlist group will receive FACT after four months.
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.
Intervention: Focused Acceptance and Commitment Therapy (Other)
Outcomes
Primary Outcomes
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).
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
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.
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
- 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.)
- Trust in the system(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(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(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(Assessed at every FACT session)