Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders
TRANSACTIVA
Efficacy of Contextual Therapies (Behavioral Activation and Acceptance and Commitment Therapy) and Cognitive Behavioral Therapy (CBT) in Group Format as a Transdiagnostic Intervention in Emotional Disorders.
1 other identifier
interventional
128
1 country
1
Brief Summary
This study aims to investigate the efficacy of three psychotherapeutic programs in group format: Acceptance and Commitment Therapy (ACT), Behavioral Activation (AC) and Transdiagnostic Cognitive Behavioral Therapy (TD-CBT), for the treatment of emotional disorders. Considering the data of the literature and the results of previous research, it is expected that this clinical investigation shows that transdiagnostic interventions that are tested (AC, ACT, TD-CBT) cause clinical changes in the post-treatment. However, it is expected that in post-treatment and in the short and medium-term follow-up, significant differences will be found between the transdiagnostic therapies examined in all outcome criteria variables; and that the greatest effectiveness and effectiveness be achieved in contextual therapies, in particular, in Behavioral Activation therapy. It is expected that the study design will allow obtaining firm evidence of the active therapeutic ingredients from the analysis of the differential efficacy of each of the psychotherapeutic programs. As a final consequence and based on the results and discussion on transdiagnostic conditions and transtherapeutic elements, it is expected to develop a unified treatment protocol (in group format -as an efficient work format and appropriate to the needs of public health services-) to be easily applied in the field of primary care. It could facilitate access to effective treatment of common mental disorders in public health services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Oct 2019
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedStudy Start
First participant enrolled
October 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMay 25, 2022
May 1, 2022
1.5 years
September 30, 2019
May 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change at Depression subscale (7 items of HADS)
frequency and intensity of depression symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of depression subscale
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Anxiety subscale (7 items of HADS)
frequency and intensity of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of anxiety subscale
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Secondary Outcomes (17)
Change at Depression scale (BDI-IA-SCA)
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at General Anxiety scale (GAD-7)
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Psychological Inflexibility scale (AAQ-II)
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Behavioral activation subscale (7 items of BADS)
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Experiential avoidance subscale (8 items of BADS)
Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
- +12 more secondary outcomes
Other Outcomes (19)
Change at perceived anxiety (PVAS)
At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks)
Change at perceived depression (PVAS)
At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks)
Change at behavioral avoidance (PVAS)
At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks)
- +16 more other outcomes
Study Arms (4)
Behavioral activation therapy
EXPERIMENTALBehavioral activation therapy was applied following the protocol designed by Martell, Dimidjian \& Herman-Dunn (2013).
Acceptance and Commitment Therapy
EXPERIMENTALAcceptance and Commitment therapy was applied following the protocol designed by Hayes, Strosahl \& Wilson, (2011).
Cognitive-Behavioral Therapy
EXPERIMENTALCognitive-Behavioral Therapy was applied following the protocol designed by Barlow, Allen and Choate (2004).
Wait List Group
OTHERParticipants at Wait List Group will be evaluated pre-post and 3, 6, 9 and 12 months follow up periods, like experimental groups.
Interventions
Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Eligibility Criteria
You may qualify if:
- Anxiety and/or depression (a score above the cutoff point in at least one of HADS subscales)
- Willingness, availability and motivation to participate in a group therapy of 8 sessions.
You may not qualify if:
- Being under another psychological treatment
- Physical and / or cognitive deterioration that hinders participation in the therapeutic plan.
- Serious illness that compromises patient's life and / or chronic cancer pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oviedo
Oviedo, Principality of Asturias, 33003, Spain
Related Publications (1)
Fernandez-Rodriguez C, Coto-Lesmes R, Martinez-Loredo V, Gonzalez-Fernandez S, Cuesta M. Is Activation the Active Ingredient of Transdiagnostic Therapies? A Randomized Clinical Trial of Behavioral Activation, Acceptance and Commitment Therapy, and Transdiagnostic Cognitive-Behavioral Therapy for Emotional Disorders. Behav Modif. 2023 Jan;47(1):3-45. doi: 10.1177/01454455221083309. Epub 2022 Apr 15.
PMID: 35426318DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 7, 2019
Study Start
October 9, 2019
Primary Completion
March 30, 2021
Study Completion
April 30, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
All IPD that underlie results in a publication are going to be share on an official data repository (Mendeley Data)