This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported internet-based cognitive behavioral therapy (iCBT) in Swedish primary care. Feasibility was assessed in terms of recruitment, intervention completion, and patient satisfaction. Symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion were assessed as secondary outcomes.
This pilot randomized controlled trial was conducted to evaluate the feasibility of RNT-ACT in Swedish primary care, using therapist-supported iCBT as an active comparator. Participants were randomized to either RNT-ACT or iCBT. RNT-ACT consisted of two 60-minute therapy sessions and audio exercises for participants to use between sessions. Participants allocated to iCBT received an internet-based cognitive behavioral therapy program for anxiety or depression, delivered through the secure Stöd och Behandling platform used in Region Skåne, with therapist support available through the platform. The primary feasibility outcomes were recruitment rate, intervention non-completion, and patient satisfaction measured with the Client Satisfaction Questionnaire (CSQ-8). Secondary outcomes included symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion. Secondary outcomes were included to describe the sample and patterns of change and were not intended to provide evidence of comparative treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Swedish Translation of the 2\*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
Therapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator.
Vårdcentralen Laröd
Helsingborg, Skåne County, Sweden
Recruitment rate
Percentage of participants enrolled among all individuals screened for participation. Calculated as the number of participants enrolled divided by the total number of individuals screened, multiplied by 100.
Time frame: At screening and enrolment.
Intervention non-completion rate
Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome.
Time frame: From randomization through completion of the allocated intervention, up to approximately 3 months.
CSQ-8
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
Time frame: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.
DASS-21
Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63, with higher values indicating greater psychological distress.
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
RRS-BR
Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Total score range 10-40, with higher values indicating a greater tendency to ruminate.
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
SAAQ
Swedish Acceptance and Action Questionnaire (SAAQ). Total score range 6-42, with higher values indicating greater psychological inflexibility.
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
Valuing Questionnaire (VQ)
Valuing Questionnaire (VQ). A 10-item self-report measure of valued living comprising two subscales, Progress and Obstruction, five items each. Each subscale has a score range of 5-35. Higher Progress scores and lower Obstruction scores indicate greater valued living. Each item is rated on a seven-point Likert-type scale ranging from 1 (Not at all true) to 7 (Completely true).
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
CFQ-7
Cognitive Fusion Questionnaire - 7 items (CFQ-7). Total score range 7-49, with higher values indicating greater cognitive fusion.
Time frame: At baseline, main post-treatment follow-up, and 3-month follow-up.
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