AnxietyTRANSACTIVANCT04117464
Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders
A study testing Behavioral activation therapy, Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy in people with Anxiety and Depression, run by University of Oviedo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Behavioral activation therapy, Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 9 Oct 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- 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.
- 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.
- Develop a unified treatment protocol for emotional disorders for implementation in primary care.
Specific objectives are:
- Identify patterns of psychological inflexibility (experiential avoidance; activation and cognitive fusion) and cognitive biases in people with emotional disorders (anxiety and / or depression).
- 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.
- 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.
- Identify the active therapeutic ingredients of the therapies on the results of the efficacy, effectiveness and adequacy of the interventions.
- 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.
- 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.
- Conditions
- Anxiety, Depression
- Being tested
- Behavioral activation therapy, Acceptance and Commitment Therapy, Cognitive-Behavioral Therapy, Wait List Group
- Keywords
- anxiety, depression, behavioral activation therapy, acceptance and commitment therapy, cognitive-behavioral therapy, transdiagnostic, group therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activation therapyBehavioural
Also called BA
Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Acceptance and Commitment TherapyBehavioural
Also called ACT
Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Cognitive-Behavioral TherapyBehavioural
Also called CBT
Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Wait List GroupOther
Also called Control Group
No psychological intervention
| Study group | Role | What they receive |
|---|---|---|
| Behavioral activation therapy | Experimental | Behavioral activation therapy was applied following the protocol designed by Martell, Dimidjian \& Herman-Dunn (2013). Receives: Behavioral: Behavioral activation therapy |
| Acceptance and Commitment Therapy | Experimental | Acceptance and Commitment therapy was applied following the protocol designed by Hayes, Strosahl \& Wilson, (2011). Receives: Behavioral: Acceptance and Commitment Therapy |
| Cognitive-Behavioral Therapy | Experimental | Cognitive-Behavioral Therapy was applied following the protocol designed by Barlow, Allen and Choate (2004). Receives: Behavioral: Cognitive-Behavioral Therapy |
| Wait List Group | Other | Participants at Wait List Group will be evaluated pre-post and 3, 6, 9 and 12 months follow up periods, like experimental groups. Receives: Other: Wait List Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
frequency and intensity of depression symptoms measured by Short form of the Beck Depression Inventory based on the cognitive-affective subscale (BDI-IA-SCA)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Post-treatment (after last session, after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start9 Oct 2019
- Primary completion30 Mar 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are simple randomized to three experimental conditions (Behavioral activation, Acceptance and commitment therapy and Cognitive-behavior therapy) and a Wait List control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Concepción Fernández-Rodríguez, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117464
- Sponsor's protocol ID
- FPU17/01181
- Acronym
- TRANSACTIVA
- Status last verified
- May 2022
- First submitted
- 30 Sep 2019
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication are going to be share on an official data repository (Mendeley Data)
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.
PubMed 35426318
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04117464
- Acronym / sponsor ID
- TRANSACTIVA / FPU17/01181
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, behavioral activation therapy, acceptance and commitment therapy, cognitive-behavioral therapy, transdiagnostic, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- Develop a unified treatment protocol for emotional disorders for implementation in primary care.
Specific objectives are:
- Identify patterns of psychological inflexibility (experiential avoidance; activation and cognitive fusion) and cognitive biases in people with emotional disorders (anxiety and / or depression).
- 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.
- 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.
- Identify the active therapeutic ingredients of the therapies on the results of the efficacy, effectiveness and adequacy of the interventions.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are simple randomized to three experimental conditions (Behavioral activation, Acceptance and commitment therapy and Cognitive-behavior therapy) and a Wait List control group
| Arm | Type | Receives |
|---|---|---|
| Behavioral activation therapy | Experimental | Behavioral: Behavioral activation therapyBehavioral activation therapy was applied following the protocol designed by Martell, Dimidjian \& Herman-Dunn (2013). |
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment therapy was applied following the protocol designed by Hayes, Strosahl \& Wilson, (2011). |
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral TherapyCognitive-Behavioral Therapy was applied following the protocol designed by Barlow, Allen and Choate (2004). |
| Wait List Group | Other | Other: Wait List GroupParticipants at Wait List Group will be evaluated pre-post and 3, 6, 9 and 12 months follow up periods, like experimental groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral activation therapyAlso: BABehavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes. | Behavioural | Behavioral activation therapy |
| Acceptance and Commitment TherapyAlso: ACTAcceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes. | Behavioural | Acceptance and Commitment Therapy |
| Cognitive-Behavioral TherapyAlso: CBTCognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes. | Behavioural | Cognitive-Behavioral Therapy |
| Wait List GroupAlso: Control GroupNo psychological intervention | Other | Wait List Group |
Primary outcome
Change at Depression subscale (7 items of HADS)
Time frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
frequency and intensity of depression symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of depression subscale
Change at Anxiety subscale (7 items of HADS)
Time frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
frequency and intensity of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of anxiety subscale
17 secondary outcomes
Change at Depression scale (BDI-IA-SCA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)
Patient satisfaction scale (CSQ-8)
Time frame: Post-treatment (after last session, after 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 35426318Fernandez-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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication are going to be share on an official data repository (Mendeley Data)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation therapy, Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy in people with Anxiety and Depression, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change at Depression subscale (7 items of HADS) (time frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.