En sammenligning af to ultrakorte interventioner i primærpleje til patienter med angst, depression og stress. (RNTACTSweden)
A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Pilot Randomized Controlled Trial.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Skåne County
-
Helsingborg, Skåne County, Sverige, 254 83
- Vårdcentralen Laröd
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- DASS-21 total score >20
- Ability to communicate in spoken and written Swedish
Exclusion Criteria:
- Physical illness requiring further medical assessment identified during routine screening
- Ongoing psychological or psychiatric treatment
- A level of suicide risk considered clinically incompatible with study participation
- Substance abuse
- Anorexia nervosa
- Psychotic disorder
- Bipolar disorder
- Attention-deficit/hyperactivity disorder (ADHD)
- Antisocial personality disorder
- A level of exhaustion considered incompatible with study participation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: RNT-ACT protocol
Participants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included. |
Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.
Andre navne:
|
|
Aktiv komparator: iCBT treatment
The people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included. |
Therapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: At screening and enrolment.
|
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. |
At screening and enrolment.
|
|
Intervention non-completion rate
Tidsramme: From randomization through completion of the allocated intervention, up to approximately 3 months.
|
Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome. |
From randomization through completion of the allocated intervention, up to approximately 3 months.
|
|
CSQ-8
Tidsramme: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.
|
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction. |
At the main post-treatment follow-up; if not completed, at the 3-month follow-up.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
DASS-21
Tidsramme: At baseline, main post-treatment follow-up, and 3-month follow-up.
|
Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63, with higher values indicating greater psychological distress. |
At baseline, main post-treatment follow-up, and 3-month follow-up.
|
|
RRS-BR
Tidsramme: At baseline, main post-treatment follow-up, and 3-month follow-up.
|
Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Total score range 10-40, with higher values indicating a greater tendency to ruminate. |
At baseline, main post-treatment follow-up, and 3-month follow-up.
|
|
SAAQ
Tidsramme: At baseline, main post-treatment follow-up, and 3-month follow-up.
|
Swedish Acceptance and Action Questionnaire (SAAQ). Total score range 6-42, with higher values indicating greater psychological inflexibility. |
At baseline, main post-treatment follow-up, and 3-month follow-up.
|
|
Valuing Questionnaire (VQ)
Tidsramme: At baseline, main post-treatment follow-up, and 3-month follow-up.
|
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). |
At baseline, main post-treatment follow-up, and 3-month follow-up.
|
|
CFQ-7
Tidsramme: At baseline, main post-treatment follow-up, and 3-month follow-up.
|
Cognitive Fusion Questionnaire - 7 items (CFQ-7). Total score range 7-49, with higher values indicating greater cognitive fusion. |
At baseline, main post-treatment follow-up, and 3-month follow-up.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Veronica Milos Nymberg, PhD, Lund University/Region Skåne
Publikationer og nyttige links
Generelle publikationer
- Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
- Andersson G, Titov N, Dear BF, Rozental A, Carlbring P. Internet-delivered psychological treatments: from innovation to implementation. World Psychiatry. 2019 Feb;18(1):20-28. doi: 10.1002/wps.20610.
- Amorim P, Lecrubier Y, Weiller E, Hergueta T, Sheehan D. DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI. Eur Psychiatry. 1998;13(1):26-34. doi: 10.1016/S0924-9338(97)86748-X.
- Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Jan;47(1):67-80. doi: 10.1017/S0033291716002270. Epub 2016 Sep 22.
- Glasgow RE, Fisher L, Strycker LA, Hessler D, Toobert DJ, King DK, Jacobs T. Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med. 2014 Mar;4(1):26-33. doi: 10.1007/s13142-013-0232-1.
- Alfonsson S, Wallin E, Maathz P. Factor structure and validity of the Depression, Anxiety and Stress Scale-21 in Swedish translation. J Psychiatr Ment Health Nurs. 2017 Mar;24(2-3):154-162. doi: 10.1111/jpm.12363. Epub 2017 Jan 25.
- Donati MA, Berrocal C, Bernini O, Gori C, Primi C. Measuring cognitive fusion through the Cognitive Fusion Questionnaire-7: Measurement invariance across non-clinical and clinical psychological samples. PLoS One. 2021 Feb 3;16(2):e0246434. doi: 10.1371/journal.pone.0246434. eCollection 2021.
- Lundgren T, Parling T. Swedish Acceptance and Action Questionnaire (SAAQ): a psychometric evaluation. Cogn Behav Ther. 2017 Jun;46(4):315-326. doi: 10.1080/16506073.2016.1250228. Epub 2016 Dec 9.
- Ruiz FJ, Pena-Vargas A, Ramirez ES, Suarez-Falcon JC, Garcia-Martin MB, Garcia-Beltran DM, Henao AM, Monroy-Cifuentes A, Sanchez PD. Efficacy of a two-session repetitive negative thinking-focused acceptance and commitment therapy (ACT) protocol for depression and generalized anxiety disorder: A randomized waitlist control trial. Psychotherapy (Chic). 2020 Sep;57(3):444-456. doi: 10.1037/pst0000273. Epub 2020 Jan 16.
- Ehring, T., & Watkins, E. R. (2008). Repetitive negative thinking as a transdiagnostic process. International Journal of Cognitive Therapy, 1(3), 192-205. https://doi.org/10.1521/ijct.2008.1.3.192
- Lecrubier, Y., Sheehan, D., Weiller, E., Amorim, P., Bonora, I., Sheehan, K., . . . Dunbar, G. (1997). The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: Reliability and validity according to the CIDI. European Psychiatry, 12(5), 224-231. doi:10.1016/S0924-9338(97)83296-8
- O'Neill, L., Latchford, G., McCracken, L. M., & Graham, C. D. (2019). The development of the acceptance and commitment therapy fidelity measure (ACT-FM): A Delphi Study and field test. Journal of Contextual Behavioral Science, 14, 111-118. https://doi.org/10.1016/j.jcbs.2019.08.008
- Schermuly-Haupt, ML., Linden, M. & Rush, A.J. Unwanted Events and Side Effects in Cognitive Behavior Therapy. Cogn Ther Res 42, 219-229 (2018). https://doi.org/10.1007/s10608-018-9904-y
- Treynor, W., Gonzalez, R. & Nolen-Hoeksema, S. Rumination Reconsidered: A Psychometric Analysis. Cognitive Therapy and Research 27, 247-259 (2003). https://doi.org/10.1023/A:1023910315561
- Silberleitner, N., Cederwald, A. von, & Robinson, P. (2021). Integrerad primärvård: Principer, färdigheter och rutiner för hela vårdcentralens arbete med Beteenderelaterad Ohälsa. Natur & Kultur.
- Bengtsson T, Wolff M, Larsson A, Nymberg P, Milos Nymberg V. Feasibility of acceptance and commitment therapy for repetitive negative thinking versus internet-based CBT: a pilot randomised controlled trial in Swedish primary care among patients with anxiety, depression and stress. Pilot Feasibility Stud. 2026 Oct 31;12(1):155. doi: 10.1186/s40814-026-01951-2.
Hjælpsomme links
- <p>Client Satisfaction Questionnaire scales</p>
- <p>Swedish platform for use of internet service in health care</p>
- <p>Social Psychology Network. Research randomizer.</p>
- <p>Swedish authority (Socialstyrelsen). April 2021. National guidelines for care in depression and anxiety disorders. Support for governance and management.</p>
- <p>Swedish authority (Socialstyrelsen) February 2018. Accessibility in health and healthcare</p>
- <p>Working Alliance Inventory.</p>
- <p>The Swedish governments official investigations. Statens Offentliga Utredningar (SOU) 2021:6 Good and close care - The right support for mental health</p>
- <p>State of the act evidence | association for contextual behavioral science.</p>
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022-06465-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .