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Adjustment DisordersNCT05464121

A Blended Intervention for Adjustment Disorder.

A study testing • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference. in people with Adjustment Disorders, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adjustment Disorders
What is being tested?
• Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSpain
Study dates
18 Nov 2022to 1 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universitat Jaume I

    Castellon, Castellón, 12071

Other trials in Spain

About this study

Official title: A Blended Intervention for Adjustment Disorder: Feasibility Trial and Preliminary Effectiveness.

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.

Read the detailed description

Adjustment disorder (AjD) is one of the most commonly diagnosed disorders in clinical practice. However, although there is still no evidence-based treatment for this problem, Cognitive Behavioral Therapy (CBT) is the most studied. Internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. However, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. The present study aims to test a blended treatment for AjD that combines a self-applied CBT programme online (TAO: Adjustment Disorder Online) with face-to-face sessions with a therapist via videoconference every 10-12 days. Only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months).

The study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies (Eldridge et al., 2016), the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth guidelines (Eysenbach, 2011), and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013a; 2013b).

Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.

Being tested
• Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.
Keywords
Adjustment Disorders, Internet-based treatment, Blended intervention, Feasibility, Videoconferencing
Medical subject headings
Adjustment Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT05464121
Study groupRoleWhat they receive
Blended intervention for AjD.ExperimentalBlended 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.
Receives: Behavioral: • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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).

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

Secondary outcomes (6)

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

    Self-report based on ICD-11 diagnostic criteria for AjD. It includes a list of stressful events and another of symptoms. Patients' symptomatology is evaluated in reference to the stressful event that they consider most interferes with them. It uses a response scale from 1 (never) to 4 (frequently). Higher scores indicate greater symptomatology. Lorenz et al. (2016) suggest that a cut off at 47.5 can differentiate between people with low and high risk of AjD.

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

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

    The IEP consists of 17 items that assess the intensity with which a situation or person lost as a result of the stressful event interferes with the patient's life. It uses a response scale from 0 (never) to 4 (always).

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

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

    The PANAS assesses two dimensions of mood (positive affect and negative affect). It consists of 20 items describing different emotions or feelings. The patient must respond to the extent to which he or she usually feels the way each expression, using a response scale from 1 (not at all or hardly at all) to 5 (very much).

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

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

    This measure includes 21 items that assess positive psychological change following an adverse or traumatic experience. It uses a response scale ranging from 0 (I did not experience this change as a result of the crisis) to 5 (I experienced this change to a great extent).

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

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

    The OASIS measures the frequency and severity of anxiety symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. Higher scores indicate greater severity or frequency of symptomatology.

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

  6. Change in the Overall Depression Severity and Impairment Scale (ODSIS; Norman et al., 2006; Mira et al., 2019).

    The ODSIS measures the frequency and severity of depressive symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. One additional item has been included to assess suicide ideation. Higher scores indicate greater severity or frequency of symptomatology.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start18 Nov 2022
  3. Primary completion1 Jun 2025
  4. Study completion1 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464121
Sponsor's protocol ID
UJaumeI_AjD_Blended
Status last verified
Feb 2026
First submitted
5 Jul 2022
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27299909

  • 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.

  • 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

  • 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.

    PubMed 29124500

  • 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.

    PubMed 32523873

  • 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.

    PubMed 30041167

  • 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.

    PubMed 31614528

  • 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.

    PubMed 30328216

  • 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.

    PubMed 32959481

  • 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.

    PubMed 29530905

  • Fernandez-Buendia S, De la Coba-Canizares L, Grimaldos J, Castilla D, Alonso-Guillen S, Cuijpers P, Quero S. A blended intervention for adjustment disorder: Results from a feasibility trial. Internet Interv. 2026 Jul 4;45:100976. doi: 10.1016/j.invent.2026.100976. eCollection 2026 Sep.

    PubMed 42437030

  • 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.

    PubMed 38313142

Questions about this trial

What is this clinical trial studying?

A study testing • Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference. in people with Adjustment Disorders, run by Universitat Jaume I at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' adherence to the intervention. (time frame: At post-treatment (approximately 12 weeks from the beginning).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464121, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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