Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders

Depression Clinical Trial

— TRANSACTIVA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117464
• Other study ID #: FPU17/01181
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Behavioral activation therapy
Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
• Acceptance and Commitment Therapy
Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
• Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.

Other:
• Wait List Group
No psychological intervention

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (2)

Lead Sponsor	Collaborator
University of Oviedo	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Patient satisfaction scale (CSQ-8)	Patient satisfaction measured by Client Satisfaction Questionnaire (CSQ-8)	Post-treatment (after last session, after 8 weeks)