Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers

NCT02292394 | Completed DMC

• 1 other identifier: PSI2012-37396
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Depression; Depressive symptoms; Prevention; Caregivers; Telephone intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months

Other Outcomes (7)

• Socio-demographic characteristics

  Pre-intervention

• Change from baseline Automatic negative thoughts to post-treatment (6 weeks)

  Pre- and post-intervention (6 weeks)

• Change from baseline Behavioral activation to post-treatment (6 weeks)

  Pre- and post-intervention (6 weeks)

Study Arms (3)

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.

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.

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.

Interventions

Multicomponent Cognitive Behavioral Telephone Intervention BEHAVIORAL

Multicomponent Cognitive Behavioral Telephone Intervention

Telephone Intervention Pleasant Activities BEHAVIORAL

Telephone Intervention Pleasant Activities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Ministry of Work and Welfare - Xunta de Galicia: collaborator

Study Sites (1)

Depressive Disorders Unit. School of Psychology. University of Santiago de Compostela.

Santiago de Compostela, Galicia/A Coruña, 15782, Spain

Location

Related Publications (13)

• 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.

  PMID: 17499078 BACKGROUND

• Attkisson 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.

  BACKGROUND

• Baessler J; Schwarzer R. Evaluación de la autoeficacia: Adaptación española de la escala de Autoeficacia General. Anxiety & Stress 1996; 2: 1-8.

  BACKGROUND

• Barraca J; Pérez-Álvaro M. Adaptación española del Environmental Reward Observation Scale (EROS). Anxiety & Stress 2010; 16: 95-107.

  BACKGROUND

• 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.

  BACKGROUND

• Hollon SD; Kendall PC. Cognitive self-statements in depression: development of an Automatic Thought Questionnaire. Cognitive Ther Res 1980; 4: 383-395.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10245370 BACKGROUND

• Radloff LS. A CES-D scale: a self-report depression scale for research in the general population. Appl Psychl Meas 1977; 1: 385-401.

  BACKGROUND

• 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.

  PMID: 17141880 BACKGROUND

• Vázquez 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.

  BACKGROUND

• Vázquez FL; Torres A; Otero P. CSQ-8 Castilian (TMS.047). Disponible en http://www.CSQscales.com; 2009.

  BACKGROUND

• 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.

  PMID: 26597295 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Fernando L. Vázquez González, Associate Professor

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor [Tenured Professor]

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 17, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

ES (1)