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.

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Behavioral activation therapy; Behavioral: Acceptance and Commitment Therapy; Behavioral: Cognitive-Behavioral Therapy; Other: Wait List Group

Detailed Description

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.

The present investigation has as general objectives:

1. Establish the effectiveness, effectiveness and efficiency of Behavioral Activation (AC), Acceptance and Commitment (ACT) and Transdiagnostic Cognitive-Behavioral (TD-CBT) therapy applied in group format for the treatment of emotional disorders in the context of Primary Care.
2. Analyze the differential utility and adequacy of contextual transdiagnostic therapy (AC; ACT) and cognitive behavioral therapy (TD-CBT) according to clinical conditions of the disorder, characteristics of the subjects and of the therapeutic procedure and the transdiagnostic assumptions that define them.
3. Develop a unified treatment protocol for emotional disorders for implementation in primary care.

Specific objectives are:

1. Identify patterns of psychological inflexibility (experiential avoidance; activation and cognitive fusion) and cognitive biases in people with emotional disorders (anxiety and / or depression).
2. To assess the efficacy, effectiveness and efficiency of three transdiagnostic therapies (AC, ACT, and TD-CBT) applied in group format for the treatment of emotional disorders, analyzing the evolution of the outcome criteria defined in relation to emotional state and functionality of the patients assigned to each experimental treatment condition and in relation to a waiting list condition.
3. Assess the adequacy and specificity of AC, ACT and TD-CBT in the treatment of emotional disorders according to different conditions: patient's clinical state, characteristics of the context and the therapeutic procedure defined as outcome criteria variables.
4. Identify the active therapeutic ingredients of the therapies on the results of the efficacy, effectiveness and adequacy of the interventions.
5. Develop a Unified Treatment Protocol to facilitate the implementation of an efficacious and effective intervention of emotional disorders in public health institutions, especially in the context of Primary Care.
6. Maintain a website to disseminate information to general population regarding services provided in the context of this research project and to share experiences with other professionals and researchers.

The sample will be composed by patients who obtain a score that indicates clinically significant symptoms according to the Hospital Anxiety and Depression Scale (HADS, Zigmond and Snaith, 1983). All participants have to sign the informed consent after being informed about the objectives and procedure of the study.

Participants that meet inclusion criteria will be randomly assigned to the experimental and control conditions. The programs will be developed in group format (maximum 8 patients / group) and will be implemented consecutively until reaching the required sample size.

Preselected patients will be interviewed by one of the researchers. The investigator explains the objectives and procedures and then participants sign the informed consent document and answer the Hospital Anxiety and Depression Scale (HADS, Zigmond and Snaith, 1983). When the result indicates clinically significant symptoms, participants will be randomly assigned (according to the table of numbers) to one of the different conditions of the investigation: three experimental (ACT; AC; TD-TCC) and a control (WL). Next, participants will be cited for an individual evaluation session in which the study variables will be explored through clinical interview and scales. After the individual evaluation session, experimental groups will receive 8 group psychotherapy sessions specific to each condition. Then, each patient have follow ups at 3, 6, 9 and 12 months after finishing the therapeutic group.

Wait List group will be evaluated after the same period of time of the experimental groups and with the same procedure. Subsequently, participants will be offered the possibility of receiving the intervention that has been shown to be most effective and / or suitable according to their peculiarities.

Therapy was administered by two licensed clinical psychologists. In order to ensure adhesion of clinical psychologists to therapeutic protocols, the intervention sessions were audio-recorded and weekly supervision sessions by the principal investigator of study were held. In addition, regular peer-to-peer coaching and supervision meetings were held to ensure protocol adherence.

Analysis of data:

The descriptive study of the sample and a study of the equivalence of control and experimental groups (with the relevant statistics according to the type of variable) will be carried out.

The investigators will study patients evolution and compare experimental and control groups in all variables using inferential statistics and evaluate the clinical change at experimental groups. For the statistical analysis a database and the statistical program IBM SPSS will be used.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33003
      • University of Oviedo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral activation therapy; Behavioral activation therapy was applied following the protocol designed by Martell, Dimidjian & Herman-Dunn (2013).	Behavioral: Behavioral activation therapy; Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; Other Names: BA
Experimental: Acceptance and Commitment Therapy; Acceptance and Commitment therapy was applied following the protocol designed by Hayes, Strosahl & Wilson, (2011).	Behavioral: Acceptance and Commitment Therapy; Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; Other Names: ACT
Experimental: Cognitive-Behavioral Therapy; Cognitive-Behavioral Therapy was applied following the protocol designed by Barlow, Allen and Choate (2004).	Behavioral: Cognitive-Behavioral Therapy; Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; Other Names: CBT
Other: Wait List Group; Participants at Wait List Group will be evaluated pre-post and 3, 6, 9 and 12 months follow up periods, like experimental groups.	Other: Wait List Group; No psychological intervention; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change at Depression scale (BDI-IA-SCA)	frequency and intensity of depression symptoms measured by Short form of the Beck Depression Inventory based on the cognitive-affective subscale (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)	frequency and intensity of anxiety symptoms measured by General Anxiety Disorder 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)	Change at psychological inflexibility measured by Acceptance & Action Questionnaire (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)	Behavioral activation pattern measured by 7 items of Behavioral Activation for Depression Scale (BADS) activation subscale	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)	Experiential avoidance pattern measured by 8 items of Behavioral Activation for Depression Scale (BADS) avoidance subscale	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Work impairment subscale (5 items of BADS)	Degree of Work impairment measured by 5 items of Behavioral Activation for Depression Scale (BADS) work impairment subscale	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Social impairment (5 items of BADS)	Degree of Social impairment measured by 5 items of Behavioral Activation for Depression Scale (BADS) social impairment subscale	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Cognitive fusion scale (CFQ)	Cognitive fusion pattern measured by Cognitive Fusion Questionnaire (CFQ)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Quality of life Scale (WHOQOL-BREF)	General Quality of life measured by WHOQOL-BREF questionnaire	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Physical Health subscale (7 items of WHOQOL-BREF)	Activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest and Work Capacity measured by 7 items of WHOQOL-BREF questionnaire	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Psychological Health subscale (6 items of WHOQOL-BREF)	Bodily image and appearance, Positive and Negative feelings, Self-esteem, Spirituality / Religion / Personal beliefs, Thinking, learning, memory and concentration, measured by 6 items of WHOQOL-BREF questionnaire	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Social relationships subscale (3 items of WHOQOL-BREF)	Personal relationships, Social support and Sexual activity measured by 3 items of WHOQOL-BREF questionnaire	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Environment subscale (8 items of WHOQOL-BREF)	Financial resources, Participation in and opportunities for recreation / leisure activities, Physical environment (pollution / noise / traffic / climate) measured by 8 items of WHOQOL-BREF questionnaire	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Cognitive reappraisal subscale (6 items of ERQ)	Cognitive reappraisal measured by 6 items of Emotion Regulation Questionnaire (ERQ) Reappraisal subscale	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Expressive suppression subscale (4 items of ERQ)	expressive suppression measured by 4 items of Emotion Regulation Questionnaire (ERQ) suppression subscale	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Positive environmental reinforcement scale (EROS)	Positive environmental reinforcement perceived by the participant in recent weeks, measured by EROS (Environmental Reward Observation Scale)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Patient satisfaction scale (CSQ-8)	Patient satisfaction measured by Client Satisfaction Questionnaire (CSQ-8)	Post-treatment (after last session, after 8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change at perceived anxiety (PVAS)	Anxiety rated by the participant by a Patients Visual analog scale (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)	Depression rated by the participant by a Patients Visual analog scale (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)	Behavioral avoidance rated by the participant by a Patients Visual analog scale (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 emotional avoidance (PVAS)	Change at relevant activities maintenance by emotional avoidance rated by the participant by a Patients Visual analog scale (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 cognitive fusion (PVAS)	Cognitive fusion rated by the participant by a Patients Visual analog scale (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 activation (PVAS)	Activation rated by the participant by a Patients Visual analog scale (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)
Self-registration techniques to asses patient adherence	Self-registers are used during treatment sessions (after 2, 3, 4, 5, 6, 7 and 8 weeks)	At session 2 (after 2 weeks), at session 3 (after 3 weeks), at session 4 (after 4 weeks), at session 5 (after 5 weeks), at session 6 (after 6 weeks), at session 7 (after 7 weeks) and at session 8 (after 8 weeks)
Change at anxiety/irritability rated by the clinician (CVAS)	Anxiety rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at depression rated by the clinician (CVAS)	Depression rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at attention to the presente rated by the clinician (CVAS)	Attention to the present rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at experiential avoidance rated by the clinician (CVAS)	Experiential avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at emotional avoidance rated by the clinician (CVAS)	Change at relevant activities maintenance by emotional avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at rumination rated by the clinician (CVAS)	Change at relevant activities maintenance by rumination rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at cognitive fusion rated by the clinician (CVAS)	Change at relevant activities maintenance by cognitive fusion rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at behavioral avoidance rated by the clinician (CVAS)	Behavioral avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at activation rated by the clinician (CVAS)	Activation rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Avoidance of relevant activities maintained by relatives rated by the clinician (CVAS)	Avoidance of relevant activities maintained by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at illness behavior maintained by relatives rated by the clinician (CVAS)	illness Behavior maintained by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Change at Healthy behavior promoted by relatives rated by the clinician (CVAS)	Healthy behavior promoted by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)	Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)

Collaborators and Investigators

• Sponsor: University of Oviedo
• Collaborators: Ministerio de Economía y Competitividad, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: depression; anxiety; acceptance and commitment therapy; cognitive-behavioral therapy; transdiagnostic; group therapy; behavioral activation therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: FPU17/01181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication are going to be share on an official data repository (Mendeley Data)
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No