A Blended Intervention for Adjustment Disorder.

NCT05464121 | Completed

• 1 other identifier: UJaumeI_AjD_Blended
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for Adjustment Disorder. This intervention combines a self-applied Internet-based program (TAO) with face-to-face sessions with a therapist via videoconference.

Conditions

Adjustment Disorders

Keywords

Adjustment Disorders; Internet-based treatment; Blended intervention; Feasibility; Videoconferencing

Outcome Measures

Primary Outcomes (5)

• Participants' adherence to the intervention.

  Drop-outs rates (and reasons), number of modules completed, number of times participants enter treatment, time spent in treatment and whether they do reviews.

  At post-treatment (approximately 12 weeks from the beginning).

• Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).

  This questionnaire consists of two different scales. Both include 6 items with a response scale ranging from 0 (not at all) to 10 (completely). One of the scales refers to the expectations about the treatment and it is administered before starting the treatment once an explanation about it has been carried out. The other scale refers to the patients' opinion once they have finished the intervention.

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Opinion Questionnaire about the intervention

  It assesses participants' opinion about TAO online program, the videoconference sessions with the therapist and the blended format. The questions refer to the satisfaction and usefulness of these components using a response scale from 0 to 10 and open-ended opinion questions.

  At post-treatment (approximately 12 weeks from the beginning).

• Working Alliance Inventory for guided Internet Interventions (WAI-I) adapted from Horvath and Greenberg (1989).

  The WAI-I scale assesses the different components of therapeutic alliance according to Bordin (1979). This version is adapted for internet-based treatments and consists of 12 items with a response scale from 1 (never) to 7 (always).

  At post-treatment (approximately 12 weeks from the beginning).

• Usability System Scale (SUS; Bangor et al., 2008; Brooke,1996).

  This scale assesses the usability of a service or product and the acceptance by the users. It consists of 10 items with a response scale ranging from 1 (strongly disagree) to 5 (strongly agree).

  At post-treatment (approximately 12 weeks from the beginning).

Secondary Outcomes (6)

• Change in Adjustment Disorder New Module-20 (ADNM-20; Einsle et al., 2010).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Change in the Loss and Stress Inventory (IEP) (Quero et al., 2019).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Change in the Positive and Negative Affect Scale (PANAS trait) (Watson et al., 1988; Díaz-García et al., 2020).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Change in the Posttraumatic Growth Inventory (PTGI) (Tadeschi and Calhoun,1996; Weiss et al., 2006).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Norman et al., 2006; González-Robles et al., 2018).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

Other Outcomes (3)

• Change in efficacy measures after each treatment module.

  After each treatment module (i.e. 7 times) for approximately 12 weeks.

• Change in the Purpose-in-Life Test-10 Items (PIL-10) (Crumbaugh and Maholick, 1964; García-Alandete et al., 2013).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

• Change in the Quality of Life Inventory (QLI) (Mezzich et al., 1986; Mezzich et al., 2000).

  At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

Study Arms (1)

Blended intervention for AjD.

EXPERIMENTAL

Blended intervention for AjD. Main components: psychoeducation, techniques for regulating emotions, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention.

Behavioral: • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.

Interventions

• Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference. BEHAVIORAL

The self-applied Internet-based program called TAO is accessible online from the platform https://psicologiaytecnologia.labpsitec.es. It is organised into 7 sequential modules of approximately 60 minutes. The patient will do a treatment module every 10-12 days, plus an individual session via videoconference with a therapist (approximately 20-30 minutes long). During these sessions, the therapist will explain the main contents of each module, resolve doubts and motivate the patient to continue with the therapy. It takes about 12 weeks to complete the intervention. TAO is the optimised version of the original intervention protocol for AjD developed by Botella et al. by Botella et al. (2008) and includes the following therapeutic components: psychoeducation, emotion regulation techniques, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention.

Blended intervention for AjD.

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Meeting diagnostic criteria for Adjustment Disorder based on the International Classification of Diseases 11 edition (ICD-11).
• Exceed the cut-off point of 47.5 on the Adjustment Disorder New Module-20 scale (ADNM-20; Lorenz et al., 2016).
• Sign an informed consent.
• Ability to understand and read Spanish.
• Ability to use a computer and having access to the Internet.
• Having an e-mail address.

You may not qualify if:

• Presence of risk of suicide or self-destructive behaviors.
• Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder).
• Receiving other psychological treatment during the study for AjD.
• An increase and/or change in the medication during the study period.

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (11)

• Bachem R, Maercker A. Self-help interventions for adjustment disorder problems: a randomized waiting-list controlled study in a sample of burglary victims. Cogn Behav Ther. 2016 Sep;45(5):397-413. doi: 10.1080/16506073.2016.1191083. Epub 2016 Jun 14.

  PMID: 27299909 BACKGROUND

• Botella, C., Baños, R. M., & Guillén, V. (2008). Una propuesta de tratamiento para los Trastornos Adaptativos: Creciendo en la adversidad. In C. Vázquez, & G. Hervás (Eds.), Psicología Positiva Aplicada. Bilbao: DDB.

  BACKGROUND

• Cucciare, M. A., Weingardt, K. R., & Villafranca, S. (2008). Using blended learning to implement evidence-based psychotherapies. Clinical Psychology: Science and Practice, 15(4), 299-307. https://doi.org/10.1111/j.1468-2850.2008.00141.x

  BACKGROUND

• Eimontas J, Rimsaite Z, Gegieckaite G, Zelviene P, Kazlauskas E. Internet-Based Self-Help Intervention for ICD-11 Adjustment Disorder: Preliminary Findings. Psychiatr Q. 2018 Jun;89(2):451-460. doi: 10.1007/s11126-017-9547-2.

  PMID: 29124500 BACKGROUND

• Leterme AC, Behal H, Demarty AL, Barasino O, Rougegrez L, Labreuche J, Duhamel A, Vaiva G, Servant D. A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial. Internet Interv. 2020 May 25;21:100329. doi: 10.1016/j.invent.2020.100329. eCollection 2020 Sep.

  PMID: 32523873 BACKGROUND

• Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.

  PMID: 30041167 BACKGROUND

• Moser C, Bachem R, Berger T, Maercker A. ZIEL: Internet-Based Self-Help for Adjustment Problems: Results of a Randomized Controlled Trial. J Clin Med. 2019 Oct 11;8(10):1655. doi: 10.3390/jcm8101655.

  PMID: 31614528 BACKGROUND

• Quero S, Moles M, Campos D, Andreu-Mateu S, Banos RM, Botella C. An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1-year follow-up efficacy data. Clin Psychol Psychother. 2019 Mar;26(2):204-217. doi: 10.1002/cpp.2342. Epub 2018 Nov 22.

  PMID: 30328216 BACKGROUND

• Rachyla I, Mor S, Cuijpers P, Botella C, Castilla D, Quero S. A guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial. Clin Psychol Psychother. 2021 Mar;28(2):313-324. doi: 10.1002/cpp.2518. Epub 2020 Oct 2.

  PMID: 32959481 BACKGROUND

• Schuster R, Fichtenbauer I, Sparr VM, Berger T, Laireiter AR. Feasibility of a blended group treatment (bGT) for major depression: uncontrolled interventional study in a university setting. BMJ Open. 2018 Mar 12;8(3):e018412. doi: 10.1136/bmjopen-2017-018412.

  PMID: 29530905 BACKGROUND

• Fernandez-Buendia S, Cuijpers P, Grimaldos J, Diaz-Garcia A, Palau-Batet M, Quero S. A blended intervention for adjustment disorder: Study protocol for a feasibility trial. Internet Interv. 2024 Jan 22;35:100715. doi: 10.1016/j.invent.2024.100715. eCollection 2024 Mar.

  PMID: 38313142 DERIVED

MeSH Terms

Conditions

Adjustment Disorders

Interventions

Troleandomycin

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oleandomycin; Macrolides; Lactones; Organic Chemicals

Study Officials

• Soledad Quero, Ph.D

  Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain

  PRINCIPAL INVESTIGATOR

• Pim Cuijpers, Ph.D

  Amsterdam Public Health Research Institute, Amsterdam, The Netherlands

  STUDY DIRECTOR

• Sara Fernández Buendía, Ph.D student

  Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain

  STUDY CHAIR

Study Design

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

Model Details: Patients will be assessed for eligibility and if they meet the inclusion criteria they will be assigned to the single treatment group (single arm). All patients will receive the same blended intervention that combines the self-applied online TAO program with videoconferencing sessions with a therapist.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: November 18, 2022
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)