DepressionRCDSNCT02292394
Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers
A study testing Multicomponent Cognitive Behavioral Telephone Intervention and Telephone Intervention Pleasant Activities in people with Depression, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Caring for dependent persons can give rise to depression in non-professional caregivers, placing a burden on health care services and threatening the quality of the care dispensed to the dependent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Multicomponent Cognitive Behavioral Telephone Intervention and Telephone Intervention Pleasant Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serves as an informal caregiver for dependent family member
- Dependence is recognized by the Xunta de Galicia
- Commitment to participate in all assessments
- A CES-D score ≥16
- Not suffering from a depressive episode
- Provides informed consent
- Has a telephone
Who cannot join
- Having received psychological or pharmacological treatment in the previous 2 months
- To present other conditions that may act as confounders (e.g., symptoms due to substance use)
- Presenting serious psychological or medical disorders that require immediate intervention (e.g., suicidal ideation) or prevent study implementation (e.g., significant cognitive impairment, severe hearing impairment)
- The dependent has a serious or terminal prognosis for the next 14 months
- Planning a change of address or institutionalization of the family member
Trial locations and contacts
1 site in 1 country.
Spain1 site
Depressive Disorders Unit. School of Psychology. University of Santiago de Compostela.
Santiago de Compostela, Galicia/A Coruña, 15782
About this study
Official title: A Study of Randomized Controlled Dismantling of a Brief Telephone Psychological Intervention Applied to Informal Caregivers With Depressive Symptoms
Caring for dependent persons can give rise to depression in non-professional caregivers, placing a burden on health care services and threatening the quality of the care dispensed to the dependent. Unfortunately, the ability of these patients to attend therapy sessions is often limited precisely by their role as caregivers. Preventive measures that are accessible to caregivers are thus called for. The primary aim of this project is to evaluate the efficacy of telephonic administration of a brief indicated preventive psychological intervention for depression that in previous work proved effective when administered in person in group sessions. With a view to optimizing resource usage by maximizing interventional efficacy, the secondary aim is to determine the contribution to overall efficacy of that part of the intervention that consists in increasing pleasant activities. To these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for inclusion in the study will be randomized to one of three interventions (≈ 60 participants per intervention): the full cognitive-behavioural programme; a program focused only on the component of pleasant activities; or a usual care condition. Both programmes will be administered in five 90 minute sessions by audio tele-conference. All sessions will be recorded for verification of adherence to the intervention protocols. Participants will be re-evaluated at the end of their intervention (when participant satisfaction with the cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months later; all evaluations will be performed by trained interviewers who will be blind to the aims of the study, the interventions employed, and the group to which any given participant belongs. Analyses of these evaluations will compare the short- and long-term efficacies of the three groups. Factors that mediate participant improvement or predict results will also be investigated, and the cost-effectiveness of the interventions will be estimated.The central hypothesis of the proposed study is that a multicomponent cognitive-behavioral telephone intervention and a protocol assessing participation in pleasant activities will both significantly reduce the incidence of depression and depressive symptoms compared to a control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month follow-up visits.
- Conditions
- Depression
- Being tested
- Multicomponent Cognitive Behavioral Telephone Intervention, Telephone Intervention Pleasant Activities
- Keywords
- Depression, Depressive symptoms, Prevention, Caregivers, Telephone intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Cognitive Behavioral Telephone InterventionBehavioural
Telephone Intervention Pleasant ActivitiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Cognitive Behavioral Telephone Intervention | Experimental | In this study, we will apply a telephone intervention that is a modified version of a brief prevention intervention for depressed caregivers that previously was applied in person in a group format during five 90-minute sessions (Vazquez et al., 2014). During the intervention, participants will be trained in various behavioral and cognitive abilities such as increasing pleasant activities, self-reinforcement, relaxation techniques, assertive communication, strategies to increase social contacts and social skills, and strategies to increase positive thoughts and decrease depressive ones. Receives: Behavioral: Multicomponent Cognitive Behavioral Telephone Intervention |
| Telephone Intervention Pleasant Activities | Experimental | This intervention is also a modified version of a protocol described by Vazquez et al. (2014). However, in this case, we will specifically focus on the behavioral activation components of the multicomponent cognitive-behavioral telephone intervention. This intervention will also be structured in groups and administered by phone in five 90-minute sessions. Receives: Behavioral: Telephone Intervention Pleasant Activities |
| Usual care | No intervention | Individuals assigned to this group will receive no intervention or material, but they will have unrestricted access to any routine medical or psychological care that they might want to seek to treat depressive symptoms. The use of such treatments will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
The presence of a major depressive episode will be assessed with the Structured Clinical Interview for Axis I Disorders from the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Clinical Version (Structured Clinical Interview for DSM-IV, Clinician Version [SCID-CV]; First, Spitzer, Gibbon and Williams, 1997/1999). This is a semi-structured interview that provides a DSM-IV diagnosis and must be administered by a clinician. It consists of six modules of diagnostic interviews: mood episodes, psychotic symptoms, psychotic disorders, mood disorders, substance use disorders, anxiety disorders, and other disorders. The SCID-CV has good test-retest reliability and adequate reliability for psychiatric patients (kappa index = 0.61)
Measured: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
Secondary outcomes (1)
Change from baseline depressive symptomatology to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale [CES-D] (Radloff, 1977; Spanish version of Vazquez, White, and Lopez, 2007). This 20-item scale is self-administered and assesses depressive symptoms. The person evaluates each item based on how often they have experienced it in the last week using a Likert scale with four response options ranging from 0 (rarely or none of the time) to 3 (most of the time). The total score ranges from 0 to 60, and higher scores correspond to greater depressive symptomatology. Internal consistency (Cronbach's alpha) of the scale ranges from .85 and .90, with .89 for the Spanish version (Vazquez et al., 2007 and 2014).
Measured: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Ministry of Work and Welfare - Xunta de Galicia
- Responsible party
- Principal investigator, Fernando Lino Vázquez González, University of Santiago de Compostela
- Investigators
- Fernando L. Vázquez González, Associate Professor, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292394
- Sponsor's protocol ID
- PSI2012-37396
- Acronym
- RCDS
- Status last verified
- May 2016
- First submitted
- 6 Nov 2014
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Armento ME, Hopko DR. The Environmental Reward Observation Scale (EROS): development, validity, and reliability. Behav Ther. 2007 Jun;38(2):107-19. doi: 10.1016/j.beth.2006.05.003. Epub 2006 Dec 12.
PubMed 17499078Attkisson CC; Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In Maruish ME, editor, The use of psychological testing for treatment planning and outcomes assessment. 3rd ed. Volume 3. Mahwah, NJ: Lawrence Erlbaum Associates; 2004. p. 799-811.
Baessler J; Schwarzer R. Evaluación de la autoeficacia: Adaptación española de la escala de Autoeficacia General. Anxiety & Stress 1996; 2: 1-8.
Barraca J; Pérez-Álvaro M. Adaptación española del Environmental Reward Observation Scale (EROS). Anxiety & Stress 2010; 16: 95-107.
First MB; Spitzer RL; Gibbon M; Williams, JBW Structured Clinical Interview for DSM-IV axis I disorders (SCID). New York: New York State Psychiatric Institute, Biometrics Research; 1997.
Hollon SD; Kendall PC. Cognitive self-statements in depression: development of an Automatic Thought Questionnaire. Cognitive Ther Res 1980; 4: 383-395.
Jerusalem M; Schwarzer R. Self-efficacy as a resource factor in stress appraisal processes. In Schwarzer R, editor. Self-efficacy: Thought control of action. Washington, DC: Hemisphere; 1992. p. 195-213.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
PubMed 10245370Radloff LS. A CES-D scale: a self-report depression scale for research in the general population. Appl Psychl Meas 1977; 1: 385-401.
Vazquez FL, Blanco V, Lopez M. An adaptation of the Center for Epidemiologic Studies Depression Scale for use in non-psychiatric Spanish populations. Psychiatry Res. 2007 Jan 15;149(1-3):247-52. doi: 10.1016/j.psychres.2006.03.004. Epub 2006 Dec 1.
PubMed 17141880Vázquez FL; Hermida E; Torres A; Otero P; Blanco V; Díaz O. Eficacia de una intervención preventiva cognitivo conductual en cuidadoras con síntomas depresivos elevados. Behav Psychol 2014; 22: 77-94.
Vázquez FL; Torres A; Otero P. CSQ-8 Castilian (TMS.047). Disponible en http://www.CSQscales.com; 2009.
Vazquez FL, Torres A, Diaz O, Otero P, Blanco V, Hermida E. Protocol for a randomized controlled dismantling study of a brief telephonic psychological intervention applied to non-professional caregivers with symptoms of depression. BMC Psychiatry. 2015 Nov 23;15:300. doi: 10.1186/s12888-015-0682-8.
PubMed 26597295
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Randomized Controlled Dismantling of a Brief Telephone Psychological Intervention Applied to Informal Caregivers With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT02292394
- Acronym / sponsor ID
- RCDS / PSI2012-37396
- Conditions
- Depression
- Keywords
- Depression, Depressive symptoms, Prevention, Caregivers, Telephone intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Ministry of Work and Welfare - Xunta de Galicia
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
Caring for dependent persons can give rise to depression in non-professional caregivers, placing a burden on health care services and threatening the quality of the care dispensed to the dependent. Unfortunately, the ability of these patients to attend therapy sessions is often limited precisely by their role as caregivers. Preventive measures that are accessible to caregivers are thus called for. The primary aim of this project is to evaluate the efficacy of telephonic administration of a brief indicated preventive psychological intervention for depression that in previous work proved effective when administered in person in group sessions. With a view to optimizing resource usage by maximizing interventional efficacy, the secondary aim is to determine the contribution to overall efficacy of that part of the intervention that consists in increasing pleasant activities. To these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for inclusion in the study will be randomized to one of three interventions (≈ 60 participants per intervention): the full cognitive-behavioural programme; a program focused only on the component of pleasant activities; or a usual care condition. Both programmes will be administered in five 90 minute sessions by audio tele-conference. All sessions will be recorded for verification of adherence to the intervention protocols. Participants will be re-evaluated at the end of their intervention (when participant satisfaction with the cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months later; all evaluations will be performed by trained interviewers who will be blind to the aims of the study, the interventions employed, and the group to which any given participant belongs. Analyses of these evaluations will compare the short- and long-term efficacies of the three groups. Factors that mediate participant improvement or predict results will also be investigated, and the cost-effectiveness of the interventions will be estimated.The central hypothesis of the proposed study is that a multicomponent cognitive-behavioral telephone intervention and a protocol assessing participation in pleasant activities will both significantly reduce the incidence of depression and depressive symptoms compared to a control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month follow-up visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Cognitive Behavioral Telephone Intervention | Experimental | Behavioral: Multicomponent Cognitive Behavioral Telephone InterventionIn this study, we will apply a telephone intervention that is a modified version of a brief prevention intervention for depressed caregivers that previously was applied in person in a group format during five 90-minute sessions (Vazquez et al., 2014). During the intervention, participants will be trained in various behavioral and cognitive abilities such as increasing pleasant activities, self-reinforcement, relaxation techniques, assertive communication, strategies to increase social contacts and social skills, and strategies to increase positive thoughts and decrease depressive ones. |
| Telephone Intervention Pleasant Activities | Experimental | Behavioral: Telephone Intervention Pleasant ActivitiesThis intervention is also a modified version of a protocol described by Vazquez et al. (2014). However, in this case, we will specifically focus on the behavioral activation components of the multicomponent cognitive-behavioral telephone intervention. This intervention will also be structured in groups and administered by phone in five 90-minute sessions. |
| Usual care | No intervention | –Individuals assigned to this group will receive no intervention or material, but they will have unrestricted access to any routine medical or psychological care that they might want to seek to treat depressive symptoms. The use of such treatments will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serves as an informal caregiver for dependent family member
- Dependence is recognized by the Xunta de Galicia
- Commitment to participate in all assessments
- A CES-D score ≥16
- Not suffering from a depressive episode
Key exclusion criteria (5 listed)
- Having received psychological or pharmacological treatment in the previous 2 months
- To present other conditions that may act as confounders (e.g., symptoms due to substance use)
- Presenting serious psychological or medical disorders that require immediate intervention (e.g., suicidal ideation) or prevent study implementation (e.g., significant cognitive impairment, severe hearing impairment)
- The dependent has a serious or terminal prognosis for the next 14 months
- Planning a change of address or institutionalization of the family member
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 |
|---|---|---|
| Multicomponent Cognitive Behavioral Telephone Intervention | Behavioural | Multicomponent Cognitive Behavioral Telephone Intervention |
| Telephone Intervention Pleasant Activities | Behavioural | Telephone Intervention Pleasant Activities |
Primary outcome
Change from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
Time frame: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
The presence of a major depressive episode will be assessed with the Structured Clinical Interview for Axis I Disorders from the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Clinical Version (Structured Clinical Interview for DSM-IV, Clinician Version [SCID-CV]; First, Spitzer, Gibbon and Williams, 1997/1999). This is a semi-structured interview that provides a DSM-IV diagnosis and must be administered by a clinician. It consists of six modules of diagnostic interviews: mood episodes, psychotic symptoms, psychotic disorders, mood disorders, substance use disorders, anxiety disorders, and other disorders. The SCID-CV has good test-retest reliability and adequate reliability for psychiatric patients (kappa index = 0.61)
1 secondary outcome
Change from baseline depressive symptomatology to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
Time frame: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
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 11 May 2016.
- Background: PubMed 17499078Armento ME, Hopko DR. The Environmental Reward Observation Scale (EROS): development, validity, and reliability. Behav Ther. 2007 Jun;38(2):107-19. doi: 10.1016/j.beth.2006.05.003. Epub 2006 Dec 12.
- BackgroundAttkisson CC; Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In Maruish ME, editor, The use of psychological testing for treatment planning and outcomes assessment. 3rd ed. Volume 3. Mahwah, NJ: Lawrence Erlbaum Associates; 2004. p. 799-811.
- BackgroundBaessler J; Schwarzer R. Evaluación de la autoeficacia: Adaptación española de la escala de Autoeficacia General. Anxiety & Stress 1996; 2: 1-8.
- BackgroundBarraca J; Pérez-Álvaro M. Adaptación española del Environmental Reward Observation Scale (EROS). Anxiety & Stress 2010; 16: 95-107.
- BackgroundFirst MB; Spitzer RL; Gibbon M; Williams, JBW Structured Clinical Interview for DSM-IV axis I disorders (SCID). New York: New York State Psychiatric Institute, Biometrics Research; 1997.
- BackgroundHollon SD; Kendall PC. Cognitive self-statements in depression: development of an Automatic Thought Questionnaire. Cognitive Ther Res 1980; 4: 383-395.
- BackgroundJerusalem M; Schwarzer R. Self-efficacy as a resource factor in stress appraisal processes. In Schwarzer R, editor. Self-efficacy: Thought control of action. Washington, DC: Hemisphere; 1992. p. 195-213.
- Background: PubMed 10245370Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- BackgroundRadloff LS. A CES-D scale: a self-report depression scale for research in the general population. Appl Psychl Meas 1977; 1: 385-401.
- Background: PubMed 17141880Vazquez FL, Blanco V, Lopez M. An adaptation of the Center for Epidemiologic Studies Depression Scale for use in non-psychiatric Spanish populations. Psychiatry Res. 2007 Jan 15;149(1-3):247-52. doi: 10.1016/j.psychres.2006.03.004. Epub 2006 Dec 1.
- BackgroundVázquez FL; Hermida E; Torres A; Otero P; Blanco V; Díaz O. Eficacia de una intervención preventiva cognitivo conductual en cuidadoras con síntomas depresivos elevados. Behav Psychol 2014; 22: 77-94.
- BackgroundVázquez FL; Torres A; Otero P. CSQ-8 Castilian (TMS.047). Disponible en http://www.CSQscales.com; 2009.
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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.
Fernando L. Vázquez González, Associate Professor principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Cognitive Behavioral Telephone Intervention and Telephone Intervention Pleasant Activities in people with Depression, run by University of Santiago de Compostela 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 7 inclusion and 5 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 11 May 2016. 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 from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months (time frame: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months). 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 NCT02292394, which also lists 13 linked publications.
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 11 May 2016.