A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

NCT05946382 | Completed

• 1 other identifier: 2022-06465-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Disorder; Mental Health Issue; Mental Depression; Anxiety; Mental Stress; Rumination - Thoughts

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At the main post-treatment follow-up; if not completed, at the 3-month follow-up.

Secondary Outcomes (5)

• DASS-21

  At baseline, main post-treatment follow-up, and 3-month follow-up.

• RRS-BR

  At baseline, main post-treatment follow-up, and 3-month follow-up.

• SAAQ

  At baseline, main post-treatment follow-up, and 3-month follow-up.

• Valuing Questionnaire (VQ)

  At baseline, main post-treatment follow-up, and 3-month follow-up.

• CFQ-7

  At baseline, main post-treatment follow-up, and 3-month follow-up.

Study Arms (2)

RNT-ACT protocol

EXPERIMENTAL

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.

Behavioral: RNT-ACT Protocol

iCBT treatment

ACTIVE COMPARATOR

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.

Behavioral: iCBT Treatment

Interventions

RNT-ACT Protocol BEHAVIORAL

Swedish Translation of the 2\*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.

Also known as: Acceptance and Commitment Therapy (ACT)

RNT-ACT protocol

iCBT Treatment BEHAVIORAL

Therapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator.

iCBT treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DASS-21 total score \>20
• Ability to communicate in spoken and written Swedish

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Vårdcentralen Laröd

Helsingborg, Skåne County, 254 83, Sweden

Location

Related Publications (18)

• 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.

  PMID: 28124410 BACKGROUND

• 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.

  PMID: 19698595 BACKGROUND

• 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.

  PMID: 30600624 BACKGROUND

• 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.

  PMID: 10259963 BACKGROUND

• 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.

  PMID: 27655039 BACKGROUND

• 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.

  PMID: 33534868 BACKGROUND

• 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.

  PMID: 24411117 BACKGROUND

• 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.

  PMID: 24653774 BACKGROUND

• 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.

  PMID: 10245370 BACKGROUND

• 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.

  PMID: 27931161 BACKGROUND

• 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.

  PMID: 31944806 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Silberleitner, N., Cederwald, A. von, & Robinson, P. (2021). Integrerad primärvård: Principer, färdigheter och rutiner för hela vårdcentralens arbete med Beteenderelaterad Ohälsa. Natur & Kultur.

  BACKGROUND

Related Links

• Client Satisfaction Questionnaire scales
• Swedish platform for use of internet service in health care
• Social Psychology Network. Research randomizer.
• Swedish authority (Socialstyrelsen). April 2021. National guidelines for care in depression and anxiety disorders. Support for governance and management.
• Swedish authority (Socialstyrelsen) February 2018. Accessibility in health and healthcare
• Working Alliance Inventory.
• The Swedish governments official investigations. Statens Offentliga Utredningar (SOU) 2021:6 Good and close care - The right support for mental health
• State of the act evidence \| association for contextual behavioral science.

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders; Stress, Psychological

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Veronica Milos Nymberg, PhD

  Lund University/Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized to one of two parallel intervention arms: RNT-ACT or therapist-supported iCBT. Participants were evaluated after completion of the allocated intervention and at 3-month follow-up.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 14, 2023
• Study Start: February 7, 2024
• Primary Completion: December 20, 2024
• Study Completion: May 25, 2025
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)