Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy (PSYADEP)

• ClinicalTrials.gov Identifier: NCT04321525
• Recruitment Status: Recruiting
• First Posted: March 25, 2020
• Last Update Posted: May 16, 2023
• Sponsor: University of Barcelona
• Collaborator: Universitat Oberta de Catalunya
• Information provided by (Responsible Party): Dr. Guillem Feixas, University of Barcelona

Study Description

Brief Summary:

Cognitive Behavioral Therapy (CBT) is the most prestigious psychological treatment for depression. However, not only do we need to increase its efficacy but also to widen the repertoire of evidence-based psychotherapeutic interventions. The importance of the patient's engagement in treatment is highlighted in the literature as a key factor for a good therapeutic outcome over and above the type of therapy. In this sense, personal construct therapy (PCT), with some promising supporting evidence, is particularly suited to fit the personal values and attitudes of each patient. In contrast to CBT, PCT does not educate patients about depression and give them directions on the changes to be made in their dysfunctional behaviors or cognitions. Rather, PCT explores their coherence with respect to the person's sense of identity, their construction of self and others, and works with the conflicts or dilemmas that appear during this conjoint exploration using the Repertory Grid Technique (RGT). In this project, for the first time, the RGT will be implemented using Virtual Reality (VR). This format could be highly appealing for young people, thus facilitating their involvement in therapy. The efficacy of this innovative application of PCT using VR (PCT-VR) will be compared to usual PCT, and to CBT in a randomized clinical trial. The Beck Depression Inventory-II is the primary outcome measure for calculating both statistical and clinical significance, but other measures will also be used at pre-, post-therapy and six-month follow up. The trial will be done in a natural health context, mostly the usual primary care center of each patient, with those who consult during the active period of the study.

Our research group has been working on both depression and personal construct theory for more than two decades (this includes our previous funded projects), particularly with a dilemma-focused intervention aimed to resolve the cognitive conflicts detected with the RGT. By fostering a technological innovation with VR, it is expected to boost the current efficacy of psychotherapy by increasing the engagement of young people and obtaining better outcomes. If these goals are met, a pathological evolution of the patient with its associated personal, health and social costs could be avoided.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: Cognitive-behavioral therapy; Behavioral: Personal Construct Therapy; Behavioral: Personal Construct Therapy with virtual reality	Not Applicable

Detailed Description:

This project will allow to test the hypothesis that a novel brief psychotherapeutic intervention, personal construct therapy with virtual reality (PCT-VR) will be more efficacious in the treatment of mild-to-moderate depression of young adults than current treatments such as the well-established Cognitive Behavioral Therapy (CBT), and the promissory personal construct therapy (PCT). It is expected that the enhancement of a current psychotherapy with VR, based on the immersive exploration of the patient's self-identity, will increase the positive effects of existing psychological therapies (at least the other therapies included in the study) in terms of symptom reduction of depressive symptoms (primary outcome), and bettering of psychological functioning, wellbeing and satisfaction. It is assumed that the use of the VR device created for this study, will make the treatment more attractive for young adults, this increasing their engagement in the therapy process. It is hypothesized that an immersive exploration of the personal constructs used to perceive self and others will facilitate self-understanding and change. As a secondary hypothesis, it is expected that PCT, thanks to its personalized and non-prescriptive nature, will be more efficacious than CBT. Also, as reflected in the literature, it is expected that the quality of the therapeutic alliance will be associated to outcome, but whether this association varies in its intensity across therapy modalities will be also explored.

General objectives With this project, it is pursued the goal of increasing the efficacy of psychological therapies for mild-to-moderate depression in young adults. It is expected to obtain better clinical results with the promissory and novel treatment modalities (PCT and PCT-VR) than with the current most prestigious CBT. By obtaining supporting evidence for these therapies, the range of psychotherapeutic alternatives for depression will be increased and this will benefit the potential for adapting the interventions to the personal styles, characteristics and preferences of each patient. An optimal personalization of the treatment favors the patient engagement in therapy and strengthens the therapeutic alliance which, in turn, should be reflected in a facilitation of the change process.

Specific objectives

1. To assess the efficacy of an innovative VR-enhanced treatment modality of psychotherapy (PCT-VR) which has never been tested before. Differential outcomes will be considered not only in terms of statistical but also clinical significance and remission rates. In addition to the reduction of depressive symptoms our study is aimed also to better psychological functioning, wellbeing and satisfaction with the services provided.

2- To evaluate the efficacy for mild-to-moderate depression in young adults of PCT, a psychotherapeutic approach with some supporting evidence for a variety of disorders and conditions but still insufficient to be considered efficacious for depression.

3- To verify the good levels of efficacy shown by CBT in the treatment of depression, mostly in international studies.

4- To identify baseline variables predicting differential outcome such as symptom severity (also comparing mild with moderate depression), and characteristics of the personal construct system such as the level of cognitive conflict.

5- To gauge the significance of the therapeutic alliance in the different treatment modalities of the study and its influence in the therapeutic outcomes measured.

6- To explore the personal views of patients with respect to the therapy process that they will have experienced as a way to advance our knowledge of the therapy process (including potential adverse effects) of each treatment. To compare this knowledge with the quantitative results of the study might be helpful for a better understanding of the entire process.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy
• Actual Study Start Date: October 15, 2021
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cognitive-behavioral therapy (CBT); Individual Cognitive Behavioral Therapy	Behavioral: Cognitive-behavioral therapy; 10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session; Other Name: Cognitive therapy
Experimental: Personal construct therapy (PCT); Individual Personal Construct Therapy	Behavioral: Personal Construct Therapy; 10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
Experimental: Personal construct therapy with virtual reality (PCT-VR); Individual Personal Construct Therapy with an immersive virtual reality app	Behavioral: Personal Construct Therapy with virtual reality; 10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Outcome Measures

Primary Outcome Measures :

1. Change in Beck depression inventory second edition [ Time Frame: BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up ]
   Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer & Brown, 1996). It is a 21-item self-report instrument to assess the existence and severity of symptoms of depression. Both the original and the Spanish version (Sanz, Perdigón, & Vázquez, 2003) showed good psychometric properties and acceptability.

Secondary Outcome Measures :

1. Clinical Outcomes in Routine Evaluation-Outcome Measure [ Time Frame: CORE-OM is administered at baseline, and then routinely every session (using short forms versions A and B) until the end of treatment (10 weeks), and 6-month follow-up ]
   Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM; Evans et al, 2002). It is a 34-item self-report questionnaire for the assessment of subjective wellbeing, symptoms or problems, life functioning and risk. It has good psychometric properties (Trujillo et al, 2016) and it has been adapted into Spanish for free distribution (www.ub.edu/terdep/core) . The short version (CORE-SFB) of 18 items will be used for session-to-session monitoring of the therapy process.
2. - Depression, Anxiety and Stress Scales [ Time Frame: DASS-21 is administered at the end of therapy (10 weeks), and 6-month follow-up ]
   Depression, Anxiety and Stress Scales (DASS-21; Lovibond & Lovibond, 1995). This 21-item version of the DASS comprises 7 items for its three scales (depression, anxiety and stress) which are moderately correlated with each other. The scores for each scale range from 0 to 21. There have been studies of validation with Spanish population finding satisfactory psychometric properties (Bados, Solanas, & Andrés, 2005).
3. Session Rating Scale 3.0 [ Time Frame: SRS 3.0 is administered routinely after every session, through intervention completion (10 weeks), and 6-month follow-up ]
   Session Rating Scale 3.0 (SRS 3.0; Duncan et al., 2003). It is a brief questionnaire designed to assess therapeutic alliance at the end of the session. It is composed of 4 items that have to be answered through a visual analog scale (VAS) of 10 centimeters. They measure the appreciation of the relationship with the therapist, agreement with the therapist about the goals and issues discussed in the session, agreement with the method or approach of the therapist, and global assessment of the session. The Spanish version obtained good levels of validity and reliability (Moggia, Niño-Robles, Miller, & Feixas, 2018)
4. Change Interview [ Time Frame: administered at the end of therapy (10 weeks) ]
   Change Interview (Elliott, Slatick and Urman, 2001). This semi-structured interview was created to assess the changes produced throughout therapy, the useful aspects, and the adverse effects of interventions from the patient's perspective. The patient is asked about the (positive) changes he/she has experienced with the intervention, as well as the negative changes if there has been any. Questions are also asked about the attribution of such changes, and their probability of occurrence without intervention. Its functions in this study are to identify both changes that patients are aware of (in their own words) which might go unnoticed with standardized questionnaires and adverse effects (too often neglected in psychotherapy research).

Other Outcome Measures:

1. Treatment adherence scale [ Time Frame: Administered at the end of therapy (up to 1 year) ]
   The Adherence to protocol scale created in a preliminary study will be used for assessing the adherence of therapists to the protocols of the assigned treatment condition. The higher the score the better the adherence in a scale from zero to ten. Two graduate students blinded to the treatment conditions and trained to use the scale reliably will rate the audiotapes of 10 sessions of CBT, PCT and PCT-VR.
2. Consumer Reports Effectiveness Scale [ Time Frame: administered at the end of therapy (10 weeks) ]
   Consumer Reports Effectiveness Scale (CRES-4 Feixas, Pucurull, Roca, Paz, García-Grau y Bados, 2012). It consists of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. The total score is intended to reflect the degree of satisfaction with treatment received. To interpret CRES-4 globally, a score is considered that is on a scale ranging from 0 to 300 points. The higher the total score, the greater the effectiveness of the treatment according to the patient.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 29 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All participants will meet diagnostic criteria for mild or moderate depressive episode according to ICD-10 (current version in the Catalan health system), diagnosed using MINI, and a score above 13 and below 29 on the BDI-II questionnaire.

Exclusion Criteria:

• Patients presenting bipolar or other affective disorders (ICD-10), psychotic symptoms, substance abuse, organic brain dysfunction, acute suicidal ideation or mental retardation will be excluded from the study. The presence of other comorbid conditions (anxiety, eating or personality disorders, etc.) will not be cause for exclusion but they will be assessed and recorded and explored statistically. Finally, those who do not have enough level of competence to communicate in Spanish or Catalan, or patients with substantial visual, hearing and cognitive deficits cannot be included

Contacts and Locations

Contacts

Contact: Guillem Feixas, Ph.D; 0034933125100; gfeixas@ub.edu

Contact: Adrian Montesano, Ph.D; 0034934505225; amontesano@uoc.edu

Locations

Spain

Hospital de Mataró; Recruiting

Mataró, Barcelona, Spain, 08304

Contact: José Cañete, MD

University of Barcelona; Not yet recruiting

Barcelona, Catalonia, Spain, 08035

Contact: Guillem Feixas, Ph.D. +34933125809 gfeixas@ub.edu

Contact: Adrián Montesano, Ph.D. +34934505225 amontesano@uoc.edu

Principal Investigator: Guillem Feixas, Ph.D.

Principal Investigator: Adrián Montesano, Ph.D.

Associació Centre Higiene Mental Nou Barris; Recruiting

Barcelona, Spain, 08042

Contact: Giusi Rametti

Sponsors and Collaborators

University of Barcelona

Universitat Oberta de Catalunya

Investigators

• Principal Investigator: Guillem Feixas, Ph.D; University of Barcelona

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Montesano A, Medina JC, Paz C, Garcia-Mieres H, Nino-Robles N, Garcia-Grau E, Crespillo JC, Garcia-Gutierrez A, Alabernia-Segura M, Feixas G. Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial. Trials. 2021 Dec 13;22(1):916. doi: 10.1186/s13063-021-05809-1.

• Responsible Party: Dr. Guillem Feixas, full professor, University of Barcelona
• ClinicalTrials.gov Identifier: NCT04321525
• Other Study ID Numbers: RTI2018-094294-B-I00
• First Posted: March 25, 2020
• Last Update Posted: May 16, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data for all primary and secondary outcomes, after deidentification
• Supporting Materials: Study Protocol
• Time Frame: Data will be available after six months of study completion
• Access Criteria: Researchers who provide a methodologically sound proposal whose proposed use of the data has been approved by an independent review committee

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders