Clinical trial NCT05071768: Virtual Focused ACT Groups in Primary Care
Official title: Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Quality of Life
Acceptance Processes
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. A growing body of research supports the efficacy of brief ACT for a variety of issues, including depression, anxiety, chronic pain, and stress. Given that ACT is a transdiagnostic intervention that targets the core processes related to human suffering, this treatment may be particularly useful for implementation in primary care with diverse groups of individuals and presentations. The objective of this study is to develop and pilot test a brief, virtual, group-based ACT intervention for depression and anxiety delivered in primary care settings to determine if a future randomized controlled trial of this group treatment is both warranted and feasible. The investigators will examine (1) the feasibility and acceptability of the study procedures, (2) clinician adherence to the treatment protocol, and (3) a preliminary analysis of the treatment effectiveness. A total of 3 groups (N = 30-45) will be conducted via three primary care clinics in Winnipeg, Manitoba, Canada. The group treatment will be delivered over four 90-minute sessions. Participants will complete assessment measures at pretreatment, post-treatment, and at two follow-up time points (1-month post-treatment and 3-6-months post-treatment). All assessments and treatment sessions will be conducted virtually via videoconferencing platform.


Eligibility criteria: Inclusion Criteria:

* self-reported symptoms of depression and/or anxiety
* fluent in English
* access to reliable internet and a device with a webcam as well as a private/quite space from which to attend sessions
* no change in psychotropic medication for at least 6 weeks prior to the intervention
* willingness to maintain a stable medication type and dose for psychotropic medications during the intervention phase and for one month post-intervention

Exclusion Criteria:

* engagement in another psychological treatment during the intervention phase or one month post-intervention
* current psychosis
* bipolar disorder
* current substance use disorder
* cognitive/intellectual impairment
* current active suicidal ideation

Primary outcomes:
measure: Depression Anxiety and Stress Scale 21-Items
timeFrame: Pretreatment
measure: Depression Anxiety and Stress Scale 21-Items
timeFrame: 1 week following last treatment session
measure: Depression Anxiety and Stress Scale 21-Items
timeFrame: 1-month follow-up
measure: Depression Anxiety and Stress Scale 21-Items
timeFrame: 3-6-month follow-up
measure: Acceptance and Action Questionnaire-II
timeFrame: Pretreament
measure: Acceptance and Action Questionnaire-II
timeFrame: 1 week following last treatment session
measure: Acceptance and Action Questionnaire-II
timeFrame: 1-month Follow-up
measure: Acceptance and Action Questionnaire-II
timeFrame: 3-6-month Follow-up
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: Pretreatment
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: 1 week following last treatment session
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: 1-month Follow-up
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: 3-6-month Follow-up
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Pretreatment
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: 1 week following last treatment session
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: 1-month Follow-up
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: 3-6-month Follow-up
Secondary outcomes:
measure: Treatment Acceptability/Adherence Scale
timeFrame: Session 2 (2 weeks after start of treatment)
measure: Percentage of planned treatment components delivered during treatment
timeFrame: Through treatment - 4 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: ACCESS Downtown
state: Manitoba
city: Winnipeg
country: Canada
facility: ACCESS Winnipeg West
state: Manitoba
city: Winnipeg
country: Canada
facility: ACCESS Fort Garry
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Erin Johns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
citation: Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Schechter D, Endicott J, Nee J. Quality of life of 'normal' controls: association with lifetime history of mental illness. Psychiatry Res. 2007 Jul 30;152(1):45-54. doi: 10.1016/j.psychres.2006.09.008. Epub 2007 Mar 23.