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

NCT04321525 | Terminated

• 1 other identifier: RTI2018-094294-B-I00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in Beck depression inventory second edition

  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.

  BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up

Secondary Outcomes (4)

• Clinical Outcomes in Routine Evaluation-Outcome Measure

  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

• - Depression, Anxiety and Stress Scales

  DASS-21 is administered at the end of therapy (10 weeks), and 6-month follow-up

• Session Rating Scale 3.0

  SRS 3.0 is administered routinely after every session, through intervention completion (10 weeks), and 6-month follow-up

• Change Interview

  administered at the end of therapy (10 weeks)

Other Outcomes (2)

• Treatment adherence scale

  Administered at the end of therapy (up to 1 year)

• Consumer Reports Effectiveness Scale

  administered at the end of therapy (10 weeks)

Study Arms (3)

Cognitive-behavioral therapy (CBT)

ACTIVE COMPARATOR

Individual Cognitive Behavioral Therapy

Behavioral: Cognitive-behavioral therapy

Personal construct therapy (PCT)

EXPERIMENTAL

Individual Personal Construct Therapy

Behavioral: Personal Construct Therapy

Personal construct therapy with virtual reality (PCT-VR)

EXPERIMENTAL

Individual Personal Construct Therapy with an immersive virtual reality app

Behavioral: Personal Construct Therapy with virtual reality

Interventions

Cognitive-behavioral therapy BEHAVIORAL

10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Also known as: Cognitive therapy

Cognitive-behavioral therapy (CBT)

Personal Construct Therapy BEHAVIORAL

10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Personal construct therapy (PCT)

Personal Construct Therapy with virtual reality BEHAVIORAL

10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Personal construct therapy with virtual reality (PCT-VR)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead
• Universitat Oberta de Catalunya: collaborator

Study Sites (2)

University of Barcelona

Barcelona, Catalonia, 08035, Spain

Location

Associació Centre Higiene Mental Nou Barris

Barcelona, 08042, Spain

Location

Related Publications (1)

• 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.

  PMID: 34903251 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Guillem Feixas, Ph.D

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 25, 2020
• Study Start: October 15, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

ES (2)