Evidence-based Synthesis Program 

(ESP) 

Family Involved Psychosocial Treatments For Adults 

with Dementia and Cancer

A Review of the Evidence

Joan M. Griffin, PhD

Core Investigator

Center for Chronic Disease Outcomes Research

Minneapolis VA Healthcare System

November 14, 2013
Evidence-based Synthesis Program 

(ESP) 

Acknowledgements 

Co-Authors

o Laura Meis, PhD

o Nancy Greer, PhD

o Agnes C. Jensen, BS

o Roderick MacDonald, MS

o Maureen Carlyle, MPH

o Indulis Rutks, BS

o Timothy J. Wilt, MD, MPH

Expert Panel/Reviewers

o Sonja Batten, PhD

o Linda Nichols, PhD

o Mark Kunik, MD, MPH 

o Meg Kabat, MSW

o Maria Silveira, MD, MPH

o Shelley MacDermid Wadsworth, 

PhD

o Connie Uphold, PhD
Evidence-based Synthesis Program 

(ESP) 

Disclosure

This report is based on research conducted by the Evidence-based Synthesis 

Program (ESP) Center located at the Minneapolis VA Healthcare System, 

Minneapolis, Minnesota, funded by the Department of Veterans Affairs, Veterans 

Health Administration, Office of Research and Development, Quality 

Enhancement Research Initiative. The findings and conclusions in this document 

are those of the author(s) who are responsible for its contents; the findings and 

conclusions do not necessarily represent the views of the Department of Veterans 

Affairs or the United States government. Therefore, no statement in this article 

should be construed as an official position of the Department of Veterans Affairs. 

No investigators have any affiliations or financial involvement (e.g., employment, 

consultancies, honoraria, stock ownership or options, expert testimony, grants or 

patents received or pending, or royalties) that conflict with material presented in 

the report.
Evidence-based Synthesis Program 

(ESP) 

VA Evidence-based Synthesis (ESP)

Program Overview

• Sponsored by VA Office of Research & Development, Quality Enhancement 

Research Initiative (QUERI).

• Established to provide timely and accurate syntheses/reviews of healthcare 

topics identified by VA clinicians, managers and policy-makers, as they work 

to improve the health and healthcare of Veterans. 

• Builds on staff and expertise already in place at the Evidence-based Practice 

Centers (EPC) designated by AHRQ. Four of these EPCs are also ESP 

Centers: 

o Durham VA Medical Center; VA Greater Los Angeles Health Care 

System; Portland VA Medical Center; and Minneapolis VA Medical 

Center.
Evidence-based Synthesis Program 

(ESP) 

• Provides evidence syntheses on important clinical practice topics relevant 

to Veterans, and these reports help:

o develop clinical policies informed by evidence, 

o the implementation of effective services to improve patient 

outcomes and to support VA clinical practice guidelines and 

performance measures, and 

o guide the direction for future research to address gaps in clinical 

knowledge.

• Broad topic nomination process – e.g. VACO, VISNs, field – facilitated by 

ESP Coordinating Center (Portland) through online process: 

 http://www.hsrd.research.va.gov/publications/esp/TopicNomination.cfm
Poll Question #1

What is your position in the VA? 

1. Student, trainee, or fellow

2. Clinician

3. Researcher

4. Manager or other policy maker

5. Other
Poll Question #2

What is your primary role in your position? (Feel free to choose multiple 

categories). 

1. I provide care/support Veteran’s families.

2. I provide care to Veterans with cancer.

3. I provide care to Veterans with dementia/Alzheimer’s Disease.

4. I am a researcher with interests in cancer.

5. I am a researcher with interests in dementia.

6. I am a researcher with interests in caregiving.

7. I am a caregiver, caring for a Veteran.

8. I develop caregiving or family-focused support programs.

9. I manage caregiver programs. 

 
Family Involved Psychosocial Treatments

Overview

1. Need for Review

2. Key Questions

3. Search Strategy

4. Analyses and Approach

5. Results

• Describe RCTs Broadly

• Address Key Question 1 by Condition

• Address Key Question 2 by Condition

6. Summarize 

7. Limitations 

8. Future Research

8 
Family Involved Psychosocial Treatments

Rationale

•Shifts in VA Care

o Greater emphasis on including families

o Expanding VA authority to provide family services

•Need to Identify

o Efficacious and promising family interventions

o Which family interventions are superior to alternative approaches 

(individually-oriented or family-oriented) 

o Which physical and mental health conditions most benefit from 

these interventions

9 
Key Question 1

What are the benefits/harms of family and 

caregiver psychosocial interventions for adult 

patients with cancer or memory related disorders

compared to usual care or wait list? 

18 cancer trials

19 memory-related disorders
Key Question 2

What are the benefits/harms of family and 

caregiver psychosocial interventions for adult 

patients with cancer or memory related disorders

compared to either: 

13 Cancer trials

14 Memory-related trials
Analytic Framework with Patient 

(vs. Caregiver) Focused Outcomes

13

Population

Adults and 

their family 

members

Patient Outcomes

Patient Outcomes: Quality of life 

(global, physical, general 

psychological functioning, 

cognitive, and social functioning), 

patient depression/anxiety, 

symptom control/management, 

and health care utilization 

Family Outcomes: Relationship 

adjustment

Adverse 

Effects

Intervention: 

Family-involved care

Comparators: 

KQ1. Usual care/wait-list 

control

KQ2. Individuallyoriented treatment/

alternative family 

treatment 

Potential modifiers

Stage of illness, relationship 

to patient, relationship quality
Search Strategy

• Literature Search: 

– MEDLINE and PsycINFO

– Search terms included: 

• family, couples, home nursing, caregivers, legal 

guardians, grandparents OR 

• couple therapy, family therapy, and marital therapy 
Search Strategy: 

Inclusion Criteria

o 1996 to Dec 2012

o English

o RCT/RCT review

o Family-involved psychosocial treatment

o Physical health condition (cancer or memory-related condition)

o Included one of the following outcomes:

 Physical functioning

 Cognitive functioning

 General psychological functioning

 Overall quality of life

 Depression/anxiety

 Symptom management/control

 Institutionalization/Health care utilization 

 
Analyses

Data extracted: 

 Condition (type and severity)

 Intervention type (multi-component, single 

component)

 Study sample characteristics

 Inclusion/exclusion criteria

 Comparator(s)

 Length of follow up

 Outcomes (assessed and data)

 Harms
Analyses

Categorization of interventions: 

 Telephone or web-based counseling (provided 

separately for family and patients)

 Behavioral couples therapy/adaptations of cognitive 

behavior therapy

 Training for family members to control patient’s 

symptoms

 Training for family members to control patient’s 

symptoms AND family support or counseling

 Unique interventions with unique intervention targets
Analyses

For all interventions, we rated their efficacy, strength of 

evidence, and quality of each RCT 

Efficacy 

1. Efficacious and specific: superior in at least 2 RCTs conducted by 

independent research teams compared to an alternative 

intervention 

2. Efficacious: superior in at least 2 RCTs conducted by independent 

research teams compared to usual care/waitlist 

3. Possibly efficacious and specific: criteria from (1) are met by a 1 

study 

4. Possibly efficacious: criteria from (2) are met by a 1 study 
Analyses

Study Quality (good, fair, poor)

1. Allocation concealment, blinding, intention-to-treat analysis, reporting of 

withdrawals/drop-outs (Higgins, 2011)

2. Treatment integrity: Stated protocol, fidelity to protocol

Strength of Evidence (low, moderate, high):

1. Confidence that the evidence reflects true effect and additional research 

is unlikely to change estimate of the effect (Owens, 2010)
Literature Search Results

Screening: 2,771 abstracts reviewed 

(excluded 1,990); 781 full text articles 

reviewed

Full Text Review: 781 articles 

(excluded 736); hand search/author 

correspondence added 14

 Included: 59 articles

 56 unique RCTs
Overview of RCTs

Health Condition Unique Trials

Trials with 

Veterans

Cancer 27 1 

Dementia/Alzheimer’s Disease 29 3 

Total 56 4 

NR = not reported
Results-Cancer

Table 1. Cancer - Summary of Baseline Characteristics (27 trials) 

Characteristics Number/mean (range) Number of trials 

reporting

Total number of patient/family dyads randomized 4195 (12-476) 27

Total number of patients from dyads analyzed 3345 (10-441) 26

Manualized/protocol based intervention Yes 23

Not reported 4 

Family intervention with:

Wife/female intimate 

partner 3 

Husband/male intimate 

partner 1 

Husband/wife or 

male/female intimate 

partner

7 

Any identified family 

member 16

Family intervention compared to (4 studies had 

usual care and active control arms)

Wait list 1 

Usual care 17

Individual treatment 2 

Other family treatment(s) 

11
Results-Cancer

Table 1. Cancer - Summary of Baseline Characteristics (27 trials) 

Characteristics Number/mean 

(range)

Number of trials 

reporting

Age of patients, years 60 (46-71) 26

Age of family members, years 56 (49-62) 21

Participant marital status, % married 80 (49-100) 19

Patient gender, % male 51 (0-100) 26

Family member gender, % female 61 (0-100) 18

Race, % non-white patients 21 (2-100) 21

Stage of cancer diagnosis* 

Early (stage 0-1) 16

Mid (stage 2-3) 16

Late (stage 4-5) 10

End of life 3 

*Groups are not mutually exclusive. 
Key Question 1 Results-Cancer

Intervention compared to usual care/waitlist

18 cancer trials

5/18 showed a significant difference in outcome

Included patients with:

Prostate cancer (n=6) 

Women with breast cancer (n=5) 

Men or women with any type of cancer (n=7) 

Compared family-involved interventions to: 

Usual care (n=17)

Wait list (n=1)

Quality 

Poor (n=3)

Fair quality (n=15) 
Summary of results

• 5/18 trials showed any significant intervention effects.

• Of these, 3 showed significant effects across multiple outcomes.

• These 3 trials targeted patients with different cancers and used intervention 

strategies. 

• Trials did not consistently improve any outcomes

• None of the studies reported on hospitalizations or institutionalization. 

• Significant trials were “possibly efficacious” (1 study, not replicated).

• Significant effect sizes were typically small to moderate. 

• Strength of evidence for intervention effectiveness was low for all outcomes, 

due to moderate risk of bias, imprecision of the effect size and poor 

methodological quality.

• Studies did not report that any patients were harmed. 

• Two trials reported family outcomes were worse for those in the 

family/couple intervention conditions than in comparator conditions. 

Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist
Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist Symptom control/management:

• 11/18 trials assessed symptom control/management 

• 4 showed significant improvements in symptom control 

• Overall moderate risk of bias and low confidence evidence reflects true effect. 

 Author Intervention Comparator Quality Efficacy

Budin Telephone Counseling Usual care fair 4 

McCorkle Family assisted approach to care Usual care poor 4 

Nezu Family assisted approach to care Wait list poor 4 

McMillan CBT (coping and problem solving) Usual care fair 4 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist

General psychological functioning:

• 10/18 trials assessed psychological functioning (including distress, well-being)

• 2 showed significant improvements in psychological functioning.

• Overall moderate risk of bias and low confidence evidence reflects true effect. 

Author Intervention Comparator Quality Efficacy

Budin TC Usual care fair 4 

Nezu Family assisted 

approach to care

Wait list poor 4 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist

Depression/anxiety

• 9/18 trials assessed depression/anxiety.

• 2 trials showed significant improvements. 

• Overall moderate risk of bias and low confidence evidence 

reflects true effect. 

Author Intervention Comparator Quality Efficacy

Nezu Family assisted 

approach to care

Wait list poor 4 

Kurtz CBT (coping and 

problem solving)

Usual care fair 4 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist

Physical and social functioning

• 9/18 trials assessed physical functioning

• 5/18 trials assessed social functioning

• 1 trial (the same trial) showed significant improvements

• Overall moderate risk of bias and low confidence evidence 

reflects true effect. 

Author Intervention Comparator Quality Efficacy

Kurtz CBT (coping and problem solving) Usual care fair 4 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 = 

Possibly Efficacious (1 study)
Global quality of life

• 6/18 assessed global quality of life

• None reported any intervention effect. 

Relationship adjustment

• 5/18 assessed relationship adjustment. 

• None reported any intervention effect. 

Key Question 1 Results-Cancer

Intervention compared to usual 

care/waitlist
Key Question 2 Results-Cancer

Intervention compared to another 

intervention

13 cancer trials

7/13 showed a significant difference in outcome

Included patients with:

Prostate cancer (n=4)

Breast cancer (n=2)

GI cancer (n=1)

Lung cancer (n=2)

Any type of cancer (n=4) 

Compared family-involved interventions to: 

Another family-involved intervention (usually psychoeducation) (n=11)

Patient-centered intervention (n=3)

Quality

Poor (n=2)

Fair (n=9)

Good (n=2)
Key Question 2 Results-Cancer

Intervention compared to another intervention

Summary 

• 7/13 trials showed a significant intervention effect.

• Of these, 2 showed significant effects across multiple outcomes.

• Significant trials were “possibly efficacious and specific” (1 study, not replicated).

• Some individual trials did improve general psychological functioning, 

depression/anxiety, and symptom control/management, but findings were inconsistent 

across trials. 

• Of the 3 trials that compared individual treatment to family or couple treatment, we 

found that the interventions were equally effective at improving outcomes at postintervention 

• The overall evidence was either low or insufficient to conclude that family-involved 

interventions were more effective than other active controls. 

• The overall strength of evidence for the superiority of family-involved interventions 

compared to active controls was low.

• Studies did not report that any patients or caregivers were harmed.
Key Question 2 Results-Cancer

Intervention compared to another intervention

Symptom control/management:

• 10/13 trials assessed symptom control/management

• 3 showed significant improvements in symptom control (2 postintervention; 1 at 6 month follow-up).

• Overall moderate risk of bias. Insufficient evidence to determine effect. 

Author Intervention Comparator Quality Efficacy

Nezu Family assisted approaches

to patient care

Patient only 

intervention

poor 3 

Gustafson Unique Education only fair 3 

Stephenson Unique Attention 

control

fair 3 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Cancer

Intervention compared to another intervention

General psychological functioning:

• 7/13 trials assessed psychological functioning (including distress, well-being)

• 3 trials reported significant differences in psychological functioning. 

• Overall moderate risk of bias and low confidence evidence reflects true effect. 

 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)

Author Intervention Comparator Quality Efficacy

Budin TC psychoeducatio

n 

fair 3 

Nezu Family assisted approaches

to patient care

patient only 

intervention

poor 3 

Mokuau Unique education fair 3 
Key Question 2 Results-Cancer

Intervention compared to another intervention

Depression/anxiety

• 5/13 trials assessed depression/anxiety.

• 2 trials showed significant improvements.

• Overall moderate risk of bias and low confidence evidence 

reflects true effect. 

Author Intervention Comparator Quality Efficacy

Badger 2007 TC 1) attention control

2) exercise

fair 3 

Stephenson Unique Attention control fair 3 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Cancer

Intervention compared to another intervention

Relationship adjustment

• 3/13 assessed relationship adjustment. 

• One reported an intervention effect. 

• Overall moderate risk of bias. Insufficient evidence to 

determine effect. 

Author Intervention Comparator Quality Efficacy

Porter Couples CBT Education/support good 3 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Cancer

Intervention compared to another intervention

Physical and social functioning

• 4/13 trials assessed physical functioning

• 2/13 trials assessed social functioning

• None of the interventions showed significant improvements over controls

• Overall moderate risk of bias. Insufficient evidence to determine effect. 

Global quality of life

• 2/13 assessed global quality of life

• Neither reported any intervention effect. 

• Overall high risk of bias. Insufficient evidence to determine effect. 
Results-Memory Related Disorders

Table 1. Memory-related Disorders- Summary of Baseline Characteristics (29 trials) 

Characteristics Number/mean (range) Number of trials 

reporting

Total number of patient/family dyads randomized 4631 29

Total number of patients from dyads analyzed 4108 29

Manualized/protocol-based intervention Yes 16

Not reported 13

Family intervention exclusively with:

 

 

 

Wife/female intimate 

partner 0 

Husband/male intimate 

partner 0 

Husband/wife or 

male/female intimate 

partner

5 

Any identified family 

member 24

Family intervention compared to (4 studies had 

usual care and active control arms)

Wait list 6 

Usual care 13

Individual treatment 1 

Other family treatment(s) 

11
Results-Memory Related Disorders

Table 1. Memory-related Disorders - Summary of Baseline Characteristics (29 trials) 

Characteristics Number/mean (range) Number of trials 

reporting

Age of patients, years 78 (73-86) 26

Age of family members, years 65 (48-74) 26

Patient gender, % male 45 (11-65) 22

Family member gender, % female 73 (54-100) 26

Participant marital status, % married 80 (51-100) 9 

Race, % non-white patients 19 (4-65) 16
Key Question 1 Results for Dementia-Intervention 

compared to usual care/waitlist

19 dementia trials

10/19 trials showed significant intervention effects.

Included patients with:

Dementia/Alzheimer’s disease

Compared family-involved interventions to: 

Usual care (n=13)

Wait list (n=6)

Sample sizes:

Range (47-406 dyads), median of 103/trial

Quality 

Poor (n=8)

Fair (n=8)

Good (n=3)
Key Question 1 Results for DementiaIntervention compared to usual care/waitlist

Summary of findings:

• Targeted interventions to groups of patients with specific symptoms 

(e.g., depression) may be more effective in managing and controlling 

symptoms and reducing depression than usual care. 

• Unique interventions (exercise promotion, quality family visits, support 

groups) significantly improved symptoms and depression Significant 

trials were “possibly efficacious” (1 study, not replicated).

• Magnitude of significant effect sizes were typically small to moderate. 

• Overall strength of evidence for intervention effectiveness was low for all 

outcomes, due to moderate risk of bias, imprecision of the effect size 

and poor methodological quality.

• Studies did not report that any patients were harmed.
Key Question 1 Results for DementiaIntervention compared to usual care/waitlist

Symptom management:

• 11/19 studies assessed symptom management or control

• 5 showed significant improvements compared to usual care or wait list 

control conditions. 

• Overall moderate risk of bias and low confidence evidence reflects true 

effect. 

Author Intervention Comparator Quality Efficacy

Gitlin, 2001 Family assisted approaches

to patient care

Usual care poor 4

Gitlin, 2008 Family assisted approaches

to patient care

Wait list good 4

Gitlin 2010 Adapted CBT Usual care fair 4

McCallion,1999 Unique intervention Usual care fair 4

Robison Unique intervention Usual care poor 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 1 Results for DementiaIntervention compared to usual care/waitlist

Depression:

• 5/19 studies that assessed depression or anxiety

• 4 showed significant improvements over control conditions.

• Overall moderate risk of bias and low confidence evidence reflects true 

effect. 

 

Author Intervention Comparator Quality Efficacy

Teri, 1997 Adapted CBT 1) Usual care

2) Wait list

fair 4

Logsdon, 2010 Unique Wait list poor 4

McCallion,1999 Unique 

intervention

Usual care fair 4

Teri, 2003 Unique Usual care fair 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 1 Results for DementiaIntervention compared to usual care/waitlist

Quality of life/overall functioning:

• 4/19 trials assessed patient quality of life

• 2 showed significant improvements over control conditions. 

• Overall moderate risk of bias and low confidence evidence reflects true 

effect. 

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)

Author Intervention Comparator Quality Efficacy

Teri, 2005 Family assisted approaches to 

patient care

Usual care fair 4

Logsdon, 2010 Unique Wait list poor 4
Key Question 1 Results for DementiaIntervention compared to usual care/waitlist

Physical functioning:

• 8/19 trials assessed

• 2 showed significant improvements. 

• Overall high risk of bias and low confidence evidence reflects true effect. 

Author Intervention Comparator Quality Efficacy

Gitlin, 2001 Family assisted approaches to 

patient care

Usual care poor 4

Teri, 2003 Unique Usual care fair 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Cognitive functioning: 

• 5/19 trials assessed

• 2 showed significant improvements.

• Overall high risk of bias and low confidence evidence reflects true effect. 

 

Author Intervention Comparator Quality Efficacy

Teri, 2005 Family assisted approaches to 

patient care

Usual care fair 4

Teri, 1997 Adapted CBT 1) Usual care

2) Wait list

fair 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)

Key Question 1 Results for Dementia-Intervention 

compared to usual care/waitlist
Health care utilization: 

• 6/19 trials assessed

• 1 showed significant reductions in institutionalization

• Overall high risk of bias and low confidence evidence reflects true effect. 

Author Intervention Comparator Quality Efficacy

Mittelman Adapted CBT Usual care good 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)

Key Question 1 Results for Dementia-Intervention 

compared to usual care/waitlist
Key Question 2 Results-Dementia

Intervention compared to another intervention

14 dementia trials

4/14 showed a significant difference in outcome

Included patients with:

Dementia/Alzheimer’s disease

Compared family-involved interventions to: 

Another family intervention (n=12)

• 9/12 included an attention control condition

A patient intervention (n=1)

Sample sizes:

Range (36-518 dyads), median of 97/trial

Quality:

Poor (n=6)

Fair (n=5)

Good (n=3)
Summary of findings:

• Studies comparing a caregiver-involved intervention to an attention 

control condition showed few improvements on outcomes. 

• Evidence is not strong enough to suggest that interventions beyond 

providing education and minimal support to caregivers are beneficial to 

patients. 

• Data were insufficient to suggest that one type of intervention is 

superior to another at improving patient outcomes. 

• Significant trials were “possibly efficacious and specific” (1 study, not 

replicated).

• Strength of evidence for intervention effectiveness was low for all 

outcomes, due to moderate risk of bias, imprecision of the effect size 

and poor methodological quality.

• No study reported poorer outcomes among patients or family members.

Key Question 2 Results-Dementia

Intervention compared to another intervention
Key Question 2 Results-Dementia

Intervention compared to another intervention

Symptom management:

• 12/14 studies assessed symptom management or control

• 2 showed significant improvements compared control conditions. 

• Overall moderate risk of bias and low confidence evidence reflects true 

effect. 

Author Intervention Comparator Quality Efficacy

Bourgeois, 2002 Family assisted 

approaches to patient care

1) Attention control

2) Self-care

good 3

Jirovec, 2001 Unique Attention control poor 3

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Dementia

Intervention compared to another intervention

Depression:

• 2/14 studies that assessed depression or anxiety

• None showed significant improvements

• Overall moderate risk of bias and low confidence evidence reflects true 

effect. 
Key Question 2 Results-Dementia

Intervention compared to another intervention

Quality of life:

• 2/14 trials assessed patient quality of life

• 1 showed significant improvements over control condition 

post-intervention. 

• Overall moderate risk of bias and low confidence evidence 

reflects true effect. 

Author Intervention Comparator Quality Efficacy

Belle, 2006 Adapted CBT Attention control fair 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Dementia

Intervention compared to another intervention

Physical functioning:

• 5/14 trials assessed patient quality of life

• 1 showed significant improvements over control condition 

post-intervention. 

• Overall moderate risk of bias and low confidence evidence 

reflects true effect. 

Author Intervention Comparator Quality Efficacy

Gitlin, 

2010

Adapted CBT Telephone support

and education

good 4

1 = Efficacious & Specific; 2 = Efficacious; 3 = Possibly Efficacious & Specific (1 study); 4 =Possibly Efficacious (1 study)
Key Question 2 Results-Dementia

Intervention compared to another intervention

Cognitive functioning: 

• 6/14 trials assessed

• None showed significant improvements.

Health care utilization: 

• 1/14 trials assessed utilization

• Did not show a reduction in institutionalization
Limitations

Studies published since 1996

• Earlier studies may yield different findings

Studies conducted in the US

• Additional work exists outside the US, but applicability of 

these trials to US Veterans unknown

Only RCTs

• Numerous observational studies and family interventions in 

various stages of development and evaluation

Only patient outcomes of interest

• Caregiver outcomes are important and possibly difficult to 

disentangle from patient outcomes
Conclusions

Limitations among Trials Reviewed

Study quality:

• Fair to poor quality

• Moderate risk of bias

• Low confidence that evidence reflects true effect.

• Poor reporting of randomization methods

• Insufficient reports of harms, final outcomes, postintervention change

• Improvements over time, but not always between 

intervention and control groups
Summary of findings:

• Tailored interventions targeting specific 

problems/behaviors may have limited effect compared to 

usual care/wait list or education only.

• Targeted interventions to distressed families/patients may 

be effective at improving outcomes. 

• No one trial was found to be efficacious or efficacious and 

specific 

• Insufficient data existed to examine effect of moderators 

(stage of disease, relationship with patient, relationship 

quality) on outcomes

• Insufficient data reported for many outcomes

• Methodological limitations to many studies 

• Clinical vs. statistical significance rarely reported
Steps forward

• Promote higher quality research 

– intervention allocation concealment and blinding most important

• Promote more consistency across studies 

– measures, intervention dose, follow up

• Replication of studies needed

• Measure and assess clinically relevant outcomes and determine 

evaluate clinically meaningful changes

• Stronger link between caregiver and care recipient outcomes needed

• Targeting sub-groups at risk may be more effective approach than 

targeting broader populations of caregivers. 

• Research specific to benefits available to caregivers of Veterans
Evidence-based Synthesis Program 

(ESP)

Questions?

If you have further questions, 

feel free to contact:

Joan Griffin, PhD

612-467-4232

Joan.Griffin@va.gov

The full report and cyberseminar presentation is available on the ESP website: 

http://www.hsrd.research.va.gov/publications/esp/