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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Disitress [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (9)

• Valuing Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessed at every FACT session]

Критерии участия

Критерии включения

(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

Критерии исключения

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Trøjborg Lægehus — Aarhus C

Идентификаторы

NCT: NCT07341425 · 1-10-72-145-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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