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

NCT05946382 | Active Not Recruiting

• 1 other identifier: 2022-06465-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• DASS-21

  Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63 with high values associated with more Depression/Anxiety/Stress.

  From assessment to 3 month follow up.

Secondary Outcomes (10)

• Drop Out rate

  Up to three months.

• Recruitment rate

  one month.

• CSQ-8

  From assessment to 3 month follow up.

• Self registered time consumption

  Up to three months.

• WAI

  From assessment to 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

Internet-based Cognitive Behavioral Therapy as mandatory routine care in Swedish Primary care and therefore considered Treatment as usual.

iCBT treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DASS-21 \>25
• Ability to communicate in Swedish orally and in writing

You may not qualify if:

• Routine blood tests are carried out including blood count, thyroid hormone, liver status and fluid balance in order to be able to differentially diagnose any physical illness.
• Other psychological or psychiatric treatment,
• Suicidality, substance abuse, Anorexia Nervosa, psychosis, bipolar disorder, attention deficit hyperactivity disorder (ADHD) and antisocial personality disorder (as verified based on M.I.N.I 7.0).

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Vårdcentralen Laröd

Helsingborg, Skåne County, 254 83, Sweden

Location

Related Publications (21)

• 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

• Horvath, A. O., & Greenberg, L. S. (1989). Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology, 36(2), 223-233. https://doi.org/10.1037/0022-0167.36.2.223

  BACKGROUND

• Livheim, F., Tengström, A., Bond, F. W., Andersson, G., Dahl, J., & Rosendahl, I. (2016). Psychometric properties of the Avoidance and Fusion Questionnaire for Youth: A psychological measure of psychological inflexibility in youth. Journal of Contextual Behavioral Science, 5(2), 103-110. https://doi.org/10.1016/j.jcbs.2016.04.001

  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

• Marchetti, I., Mor, N., Chiorri, C. et al. The Brief State Rumination Inventory (BSRI): Validation and Psychometric Evaluation. Cogn Ther Res 42, 447-460 (2018). https://doi.org/10.1007/s10608-018-9901-1

  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
• Masking Details: Patients are made aware of the study through information material at the primary care unit in the waiting room and on the therapists door. There they can notify the contact person about their interest. Letter with information about the study will be sent out to the interested patient. If the patient chooses to participate by answering positively on the information letter, they will be contacted by telephone by a psychologist at the respective primary care unit for the opportunity to ask questions and to book an appointment for a baseline measurement at the unit. After the baseline measurement the patient is randomly assigned to one of the treatment arms. Measurements with all self-assessment scales are carried out at week 0, at the end of treatment and 3 months after the end of treatment. The participants are then offered the opportunity for a follow-up 12 months after completion of treatment using the same scales as the 3-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After assessment the participant receives either the RNT-ACT arm or the iCBT arm. When the treatment is finished, the patient is called to an evaluation visit. If the person still needs care, we are faced with two choices. Either the patient is offered usual care and is thus removed from the three-month follow-up.Or it will wait for three-month follow up.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 14, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)